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1. Effects of restrictive fluid therapy on the time to resolution of hyperlactatemia in ICU patients with septic shock. A secondary post hoc analysis of the CLASSIC randomized trial

Author

Ahlstedt, Christian, Sivapalan, Praleene, Kriz, Miroslav, Jacobson, Gustaf, Sylvest Meyhoff, Tine, Skov Kaas-Hansen, Benjamin, Holm, Manne, Hollenberg, Jacob, Nalos, Marek, Rooijackers, Olav, Hylander Møller, Morten, Cronhjort, Maria, Perner, Anders, and Grip, Jonathan

Published
2024
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2. How often are infusion sets for central venous catheters changed in Australian and New Zealand Intensive Care Units? A point prevalence survey

Author

Hammond, Naomi, Freeman-Sanderson, Amy, Ganu, Subodh, Howe, Belinda, Litton, Ed, Mackle, Diane, Saxena, Manoj, Seppelt, Ian, Towns, Miriam, Yarad, Elizabeth, Knowles, Serena, Gao, Annie, Li, Yang, Myburgh, John, Nangla, Conrad, Butt, Fatima, Duke, Graeme, Hunter, Stephanie, Evans, Julie, Parker, Dianne, Loughnan, Clare, Thomas, Blessy, Gilder, Eileen, Robertson, Melissa, McMahon, Ellie, Ali, Farisha, Cowdrey, Keri-Anne, McArthur, Colin, Chen, Yan, Simmonds, Catherine, McConnochie, Rachael, O'Connor, Caroline, El-Khawas, Khaled, Hill, Dianne, Cattigan, Claire, Horton, Michelle, Trickey, Jemma, Knott, Cameron, Smith, Julie, Boschert, Catherine, Sara, Treena, Nand, Kiran, Ramanan, Mahesh, Marella, Prashanti, Affleck, Julia, Simpson, Shannon, Ellem, Katrina, McKenna, Toni, Nourse, Mary, Leung, Kristine, Edmunds, Tash, McDonald, Bree, Mehrtens, Jan, Cross, Rosalba, Wong, Helen, Twardowski, Pawel, France, Dawn, Hanlon, Gabrielle, Barrett, Jonathan, Palermo, Annamaria, Pellicano, Susan, Eroglu, Ege, Bihari, Shailesh, Brown, Julia, Grear, Laura, Jin, Xia, French, Craig, Bates, Samantha, Marshall, Fiona, McEldrew, Rebecca, McCullough, James, Tallott, Mandy, Gough, Maimoonbe, Nalos, Marek, Younger, Laura, Krishnamurphy, Ravi, Trent, Louise, How, Janet, Stuart, Anne, Chadwick, Llesley, Bhadange, Neeraj, Tyler, Steven, Sosnowski, Kellie, Morrison, Lynette, Sutton, Joanne, Soar, Natalie, Lee, David, Doyle, Marina, Jongebloed, Katherine, Finnis, Mackenzie, Wilson, Jane, Williams, Tony, Song, Rima, Lai, Vivian, Girijadevi, Dinu, Habraken, Hannah, Browne, Alex, Koelle, Jette, McNab, Charlotte, Masters, Kristy, Gresham, Rebecca, Lowrey, Julie, Whitehead, Christina, Liang, Janet, Harward, Meg, Jones, Cassie, Peake, Sandra, Williams, Tricia, Kurenda, Catherine, Tabah, Alexis, Duroux, Maree, Warhurst, Timothy, Ratcliffe, Megan, Pollock, Hamish, Baker, Stuart, Sonawane, Ravikiran, O'Connor, Stephanie, Brown, Nerissa, Glasby, Kathleen, Rivett, Justine, Campbell, Lewis, Tabuzo, Vera, Smyth, Kirsty, Bass, Frances, O'Connor, Anne, Leonard, Anton, Waterson, Sharon, Coles, Jennifer, Buhr, Heidi, Newman, Duncan, Boorawong, Piyaporn, Bregolin, Vanessa, Yun, Ji-Hyun, Anstey, Matthew, Rock, Lara, Endemann, Anthadene, Lo, Wei, Ferrier, Janet, Reynolds, Claire, Santamaria, John, Holmes, Jennifer, Beca, John, Sherring, Claire, Garrett, Peter, Murray, Lauren, Brailsford, Jane, Browne, Troy, Goodson, Jennifer, Udy, Andrew, Young, Meredith, Board, Jasmin, McCracken, Phoebe, Martin, Emma-Leah, Martynoga, Robert, Butler, Amelia, Trask, Kara, Olatunji, Shaanti, Cruz, Rhoze Sol, Cruz, Raulle Sol, Navarra, Leanlove, Delaney, Kirsha, Lesona, Eden, Young, Chelsea, Spring, Amelia, Aguilar, April, Young, Paul, Law, Erin, Anstey, Matthew H., Maxwell, Nicky, Rickard, Claire M., Hammond, Naomi E., and McGain, Forbes

Published
2024
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3. Long-term effects of restriction of intravenous fluid in adult ICU patients with septic shock

Author

Kjær, Maj-Brit Nørregaard, Meyhoff, Tine Sylvest, Sivapalan, Praleene, Granholm, Anders, Hjortrup, Peter Buhl, Madsen, Martin Bruun, Møller, Morten Hylander, Egerod, Ingrid, Wetterslev, Jørn, Lange, Theis, Cronhjort, Maria, Laake, Jon Henrik, Jakob, Stephan M., Nalos, Marek, Ostermann, Marlies, Gould, Doug, Cecconi, Maurizio, Malbrain, Manu L. N. G., Ahlstedt, Christian, Kiel, Louise Bendix, Bestle, Morten H., Nebrich, Lars, Hildebrandt, Thomas, Russell, Lene, Vang, Marianne, Rasmussen, Michael Lindhart, Sølling, Christoffer, Brøchner, Anne Craveiro, Krag, Mette, Pfortmueller, Carmen, Kriz, Miroslav, Siegemund, Martin, Albano, Giovanni, Aagaard, Søren Rosborg, Bundgaard, Helle, Crone, Vera, Wichmann, Sine, Johnstad, Bror, Martin, Yvonne Karin, Seidel, Philipp, Mårtensson, Johan, Hollenberg, Jacob, Wistrand, Mats, Donati, Abele, Barbara, Enrico, Karvunidis, Thomas, Hollinger, Alexa, Carsetti, Andrea, Lumlertgul, Nuttha, Joelsson-Alm, Eva, Lambiris, Nikolas, Aslam, Tayyba Naz, Friberg, Fredrik Femtehjell, Vesterlund, Gitte Kingo, Mortensen, Camilla Bekker, Vestergaard, Stine Rom, Caspersen, Sidsel Fjordbak, Jensen, Diana Bertelsen, Borup, Morten, Rasmussen, Bodil Steen, and Perner, Anders

Published
2023
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4. Host transcriptomics and machine learning for secondary bacterial infections in patients with COVID-19: a prospective, observational cohort study

Author

Carney, Meagan, Pelaia, Tiana M, Chew, Tracy, Teoh, Sally, Phu, Amy, Kim, Karan, Wang, Ya, Iredell, Jonathan, Cirmena, Gabriella, Ballestrero, Alberto, Cripps, Allan, Cox, Amanda, De Maria, Andrea, Kulasinghe, Arutha, Feng, Carl, Chaussabel, Damien, Rinchai, Darawan, Bedognetti, Davide, Zoppoli, Gabriele, Gunawan, Gunawan, Thevarajan, Irani, Audsley, Jennifer, Eden, John-Sebastian, Kralovcova, Marcela, Nalos, Marek, Radic, Marko, Matejovic, Martin, Bedognetti, Michele, Prucha, Miroslav, Toufiq, Mohammed, Teluguakula, Narasaraju, West, Nicholas, Cremonesi, Paolo, Britton, Philip, Branco, Ricardo G, Bilyy, Rostyslav, MacDonald, Stephen, Karvunidis, Thomas, Kwan, Tim, Herwanto, Velma, Kuan, Win Sen, Zerbib, Yoann, McLean, Anthony, Schughart, Klaus, Tang, Benjamin, Shojaei, Maryam, Short, Kirsty R, and Pelaia, Tiana Maria

Published
2024
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5. How much do we throw away in the intensive care unit? An observational point prevalence study of Australian and New Zealand ICUs

Author

Hammond, Naomi, Knowles, Serena, Freeman-Sanderson, Amy, Ganu, Subodh, Howe, Belinda, Litton, Ed, Mackle, Diane, Saxena, Manoj, Seppelt, Ian, Towns, Miriam, Yarad, Elizabeth, Hammond, Gao, Annie, Li, Yang, Myburgh, John, Nangla, Conrad, Butt, Fatima, Duke, Graeme, Hunter, Stephanie, Evans, Julie, Parker, Dianne, Loughnan, Clare, Thomas, Blessy, Gilder, Eileen, Robertson, Melissa, McMahon, Ellie, Ali, Farisha, Cowdrey, Keri-Anne, McArthur, Colin, Chen, Yan, Simmonds, Catherine, McConnochie, Rachael, O'Connor, Caroline, El-Khawas, Khaled, Hill, Dianne, Cattigan, Claire, Horton, Michelle, Trickey, Jemma, Knott, Cameron, Smith, Julie, Boschert, Catherine, Sara, Treena, Nand, Kiran, Ramanan, Mahesh, Marella, Prashanti, Affleck, Julia, Simpson, Shannon, Ellem, Katrina, McKenna, Toni, Nourse, Mary, Leung, Kristine, Edmunds, Tash, McDonald, Bree, Mehrtens, Jan, Cross, Rosalba, Wong, Helen, Twardowski, Pawel, France, Dawn, Hanlon, Gabrielle, Barrett, Jonathan, Palermo, Annamaria, Pellicano, Susan, Eroglu, Ege, Bihari, Shailesh, Brown, Julia, Grear, Laura, Jin, Xia, French, Craig, Bates, Samantha, Marshall, Fiona, McEldrew, Rebecca, McCullough, James, Tallott, Mandy, Gough, Maimoonbe, Nalos, Marek, Younger, Laura, Krishnamurphy, Ravi, Trent, Louise, How, Janet, Stuart, Anne, Chadwick, Llesley, Bhadange, Neeraj, Tyler, Steven, Sosnowski, Kellie, Morrison, Lynette, Sutton, Joanne, Soar, Natalie, Lee, David, Doyle, Marina, Jongebloed, Katherine, Finnis, Mackenzie, Wilson, Jane, Williams, Tony, Song, Rima, Lai, Vivian, Girijadevi, Dinu, Habraken, Hannah, Browne, Alex, Koelle, Jette, McNab, Charlotte, Masters, Kristy, Gresham, Rebecca, Lowrey, Julie, Whitehead, Christina, Liang, Janet, Harward, Meg, Jones, Cassie, Peake, Sandra, Williams, Tricia, Kurenda, Catherine, Tabah, Alexis, Duroux, Maree, Warhurst, Timothy, Ratcliffe, Megan, Pollock, Hamish, Baker, Stuart, Sonawane, Ravikiran, O'Connor, Stephanie, Brown, Nerissa, Glasby, Kathleen, Rivett, Justine, Campbell, Lewis, Tabuzo, Vera, Smyth, Kirsty, Bass, Frances, O'Connor, Anne, Leonard, Anton, Waterson, Sharon, Coles, Jennifer, Buhr, Heidi, Newman, Duncan, Boorawong, Piyaporn, Bregolin, Vanessa, Yun, Ji-Hyun, Anstey, Matthew, Rock, Lara, Endemann, Anthadene, Lo, Wei, Ferrier, Janet, Reynolds, Claire, Santamaria, John, Holmes, Jennifer, Beca, John, Sherring, Claire, Garrett, Peter, Murray, Lauren, Brailsford, Jane, Browne, Troy, Goodson, Jennifer, Udy, Andrew, Young, Meredith, Board, Jasmin, McCracken, Phoebe, Martin, Emma-Leah, Martynoga, Robert, Butler, Amelia, Trask, Kara, Olatunji, Shaanti, Cruz, Rhoze Sol, Cruz, Raulle Sol, Navarra, Leanlove, Delaney, Kirsha, Lesona, Eden, Young, Chelsea, Spring, Amelia, Aguilar, April, Young, Paul, Law, Erin, Anstey, Matthew H., Bhonagiri, Deepak, Hammond, Naomi E., and McGain, Forbes

Published
2023
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6. Long-term effects of restriction of intravenous fluid in adult ICU patients with septic shock

Author

Kjær, Maj Brit Nørregaard, primary, Meyhoff, Tine S., additional, Sivapalan, Praleene, additional, Granholm, Andrers, additional, Hjortrup, Peter B., additional, Madsen, Martin B., additional, Hylander, Morten H., additional, Egerod, Ingrid, additional, Wetterslev, Jørn, additional, Lange, Theis, additional, Cronhjort, Maria, additional, Laake, Jon H., additional, Jakob, Stephan M., additional, Nalos, Marek, additional, Ostermann, Marlies, additional, Gould, Doug, additional, Cecconi, Maurizio, additional, Malbrain, Manu L.N.G., additional, Ahlstedt, Christian, additional, Kiel, Louise B., additional, Bestle, Morten H., additional, Nebrich, Lars, additional, Hildebrandt, Thomas, additional, Russell, Lene, additional, Vang, Marianne, additional, Rasmussen, Michael L., additional, Sølling, Christioffer, additional, Brøchner, Anne C., additional, Krag, Mette, additional, and Perner, Anders, additional

Published
2024
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7. How often are infusion sets for central venous catheters changed in Australian and New Zealand Intensive Care Units? A point prevalence survey

Author

Anstey, Matthew H., primary, Maxwell, Nicky, additional, Rickard, Claire M., additional, Hammond, Naomi E., additional, Knowles, Serena, additional, McGain, Forbes, additional, Hammond, Naomi, additional, Freeman-Sanderson, Amy, additional, Ganu, Subodh, additional, Howe, Belinda, additional, Litton, Ed, additional, Mackle, Diane, additional, Saxena, Manoj, additional, Seppelt, Ian, additional, Towns, Miriam, additional, Yarad, Elizabeth, additional, Gao, Annie, additional, Li, Yang, additional, Myburgh, John, additional, Nangla, Conrad, additional, Butt, Fatima, additional, Duke, Graeme, additional, Hunter, Stephanie, additional, Evans, Julie, additional, Parker, Dianne, additional, Loughnan, Clare, additional, Thomas, Blessy, additional, Gilder, Eileen, additional, Robertson, Melissa, additional, McMahon, Ellie, additional, Ali, Farisha, additional, Cowdrey, Keri-Anne, additional, McArthur, Colin, additional, Chen, Yan, additional, Simmonds, Catherine, additional, McConnochie, Rachael, additional, O'Connor, Caroline, additional, El-Khawas, Khaled, additional, Hill, Dianne, additional, Cattigan, Claire, additional, Horton, Michelle, additional, Trickey, Jemma, additional, Knott, Cameron, additional, Smith, Julie, additional, Boschert, Catherine, additional, Sara, Treena, additional, Nand, Kiran, additional, Ramanan, Mahesh, additional, Marella, Prashanti, additional, Affleck, Julia, additional, Simpson, Shannon, additional, Ellem, Katrina, additional, McKenna, Toni, additional, Nourse, Mary, additional, Leung, Kristine, additional, Edmunds, Tash, additional, McDonald, Bree, additional, Mehrtens, Jan, additional, Cross, Rosalba, additional, Wong, Helen, additional, Twardowski, Pawel, additional, France, Dawn, additional, Hanlon, Gabrielle, additional, Barrett, Jonathan, additional, Palermo, Annamaria, additional, Pellicano, Susan, additional, Eroglu, Ege, additional, Bihari, Shailesh, additional, Brown, Julia, additional, Grear, Laura, additional, Jin, Xia, additional, French, Craig, additional, Bates, Samantha, additional, Marshall, Fiona, additional, McEldrew, Rebecca, additional, McCullough, James, additional, Tallott, Mandy, additional, Gough, Maimoonbe, additional, Nalos, Marek, additional, Younger, Laura, additional, Krishnamurphy, Ravi, additional, Trent, Louise, additional, How, Janet, additional, Stuart, Anne, additional, Chadwick, Llesley, additional, Bhadange, Neeraj, additional, Tyler, Steven, additional, Sosnowski, Kellie, additional, Morrison, Lynette, additional, Sutton, Joanne, additional, Soar, Natalie, additional, Lee, David, additional, Doyle, Marina, additional, Jongebloed, Katherine, additional, Finnis, Mackenzie, additional, Wilson, Jane, additional, Williams, Tony, additional, Song, Rima, additional, Lai, Vivian, additional, Girijadevi, Dinu, additional, Habraken, Hannah, additional, Browne, Alex, additional, Koelle, Jette, additional, McNab, Charlotte, additional, Masters, Kristy, additional, Gresham, Rebecca, additional, Lowrey, Julie, additional, Whitehead, Christina, additional, Liang, Janet, additional, Harward, Meg, additional, Jones, Cassie, additional, Peake, Sandra, additional, Williams, Tricia, additional, Kurenda, Catherine, additional, Tabah, Alexis, additional, Duroux, Maree, additional, Warhurst, Timothy, additional, Ratcliffe, Megan, additional, Pollock, Hamish, additional, Baker, Stuart, additional, Sonawane, Ravikiran, additional, O'Connor, Stephanie, additional, Brown, Nerissa, additional, Glasby, Kathleen, additional, Rivett, Justine, additional, Campbell, Lewis, additional, Tabuzo, Vera, additional, Smyth, Kirsty, additional, Bass, Frances, additional, O'Connor, Anne, additional, Leonard, Anton, additional, Waterson, Sharon, additional, Coles, Jennifer, additional, Buhr, Heidi, additional, Newman, Duncan, additional, Boorawong, Piyaporn, additional, Bregolin, Vanessa, additional, Yun, Ji-Hyun, additional, Anstey, Matthew, additional, Rock, Lara, additional, Endemann, Anthadene, additional, Lo, Wei, additional, Ferrier, Janet, additional, Reynolds, Claire, additional, Santamaria, John, additional, Holmes, Jennifer, additional, Beca, John, additional, Sherring, Claire, additional, Garrett, Peter, additional, Murray, Lauren, additional, Brailsford, Jane, additional, Browne, Troy, additional, Goodson, Jennifer, additional, Udy, Andrew, additional, Young, Meredith, additional, Board, Jasmin, additional, McCracken, Phoebe, additional, Martin, Emma-Leah, additional, Martynoga, Robert, additional, Butler, Amelia, additional, Trask, Kara, additional, Olatunji, Shaanti, additional, Cruz, Rhoze Sol, additional, Cruz, Raulle Sol, additional, Navarra, Leanlove, additional, Delaney, Kirsha, additional, Lesona, Eden, additional, Young, Chelsea, additional, Spring, Amelia, additional, Aguilar, April, additional, Young, Paul, additional, and Law, Erin, additional

Published
2024
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8. Effects of IV fluid restriction according to site‐specific intensity of standard fluid treatment—protocol.

Author

Sivapalan, Praleene, Kaas‐Hansen, Benjamin Skov, Meyhoff, Tine Sylvest, Hjortrup, Peter Buhl, Kjær, Maj‐Brit N., Laake, Jon Henrik, Cronhjort, Maria, Jakob, Stephan M., Cecconi, Maurizio, Nalos, Marek, Ostermann, Marlies, Malbrain, Manu L. N. G., Møller, Morten Hylander, Perner, Anders, and Granholm, Anders

Subjects
MACHINE learning, BOOSTING algorithms, SEPTIC shock, FLUID therapy, SHOCK therapy
Abstract

Background: Variation in usual practice in fluid trials assessing lower versus higher volumes may affect overall comparisons. To address this, we will evaluate the effects of heterogeneity in treatment intensity in the Conservative versus Liberal Approach to Fluid Therapy of Septic Shock in Intensive Care trial. This will reflect the effects of differences in site‐specific intensities of standard fluid treatment due to local practice preferences while considering participant characteristics. Methods: We will assess the effects of heterogeneity in treatment intensity across one primary (all‐cause mortality) and three secondary outcomes (serious adverse events or reactions, days alive without life support and days alive out of hospital) after 90 days. We will classify sites based on the site‐specific intensity of standard fluid treatment, defined as the mean differences in observed versus predicted intravenous fluid volumes in the first 24 h in the standard‐fluid group while accounting for differences in participant characteristics. Predictions will be made using a machine learning model including 22 baseline predictors using the extreme gradient boosting algorithm. Subsequently, sites will be grouped into fluid treatment intensity subgroups containing at least 100 participants each. Subgroups differences will be assessed using hierarchical Bayesian regression models with weakly informative priors. We will present the full posterior distributions of relative (risk ratios and ratios of means) and absolute differences (risk differences and mean differences) in each subgroup. Discussion: This study will provide data on the effects of heterogeneity in treatment intensity while accounting for patient characteristics in critically ill adult patients with septic shock. Registrations: The European Clinical Trials Database (EudraCT): 2018‐000404‐42, ClinicalTrials. gov: NCT03668236. [ABSTRACT FROM AUTHOR]

Published
2024
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9. Albumin use in patients with septic shock—Post-hoc analyses of an international randomised fluid trial

Author

Meyhoff, Tine Sylvest, Granholm, Anders, Hjortrup, Peter Buhl, Sivapalan, Praleene, Lange, Theis, Laake, Jon Henrik, Cronhjort, Maria, Jakob, Stephan M., Cecconi, Maurizio, Nalos, Marek, Ostermann, Marlies, Malbrain, Manu L.N.G., Møller, Morten Hylander, Perner, Anders, Meyhoff, Tine Sylvest, Granholm, Anders, Hjortrup, Peter Buhl, Sivapalan, Praleene, Lange, Theis, Laake, Jon Henrik, Cronhjort, Maria, Jakob, Stephan M., Cecconi, Maurizio, Nalos, Marek, Ostermann, Marlies, Malbrain, Manu L.N.G., Møller, Morten Hylander, and Perner, Anders

Abstract

Background Albumin administration is suggested in patients with sepsis and septic shock who have received large volumes of crystalloids. Given lack of firm evidence, clinical practice variation may exist. To address this, we investigated if patient characteristics or trial site were associated with albumin use in septic shock. Methods We conducted a post-hoc study of the CLASSIC international, randomised clinical trial of fluid volumes in septic shock. Associations between selected baseline variables and trial site with albumin use during ICU stay were assessed in Cox models considering death, ICU discharge, and loss-to-follow-up as competing events. Baseline variables were first assessed individually, adjusted for treatment allocation (restrictive vs. standard IV fluid), and then adjusted for allocation and the other baseline variables. Site was assessed in a model adjusted for allocation and baseline variables. Results We analysed 1541 of 1554 patients randomised in CLASSIC (99.2%). During ICU stay, 36.3% of patients in the restrictive-fluid group and 52.6% in the standard-fluid group received albumin. Gastrointestinal focus of infection and higher doses of norepinephrine were most strongly associated with albumin use (subgroup with highest quartile of norepinephrine doses, hazard ratio (HR) 2.58, 95% CI 1.89 to 3.53). HRs for associations between site and albumin use ranged from 0.11 (95% CI 0.05 to 0.26) to 1.70 (95% CI 1.06 to 2.74); test for overall effect of site: p < .001. Conclusions In adults with septic shock, gastrointestinal focus of infection and higher doses of norepinephrine at baseline were associated with albumin use, which also varied substantially between sites., Background: Albumin administration is suggested in patients with sepsis and septic shock who have received large volumes of crystalloids. Given lack of firm evidence, clinical practice variation may exist. To address this, we investigated if patient characteristics or trial site were associated with albumin use in septic shock. Methods: We conducted a post-hoc study of the CLASSIC international, randomised clinical trial of fluid volumes in septic shock. Associations between selected baseline variables and trial site with albumin use during ICU stay were assessed in Cox models considering death, ICU discharge, and loss-to-follow-up as competing events. Baseline variables were first assessed individually, adjusted for treatment allocation (restrictive vs. standard IV fluid), and then adjusted for allocation and the other baseline variables. Site was assessed in a model adjusted for allocation and baseline variables. Results: We analysed 1541 of 1554 patients randomised in CLASSIC (99.2%). During ICU stay, 36.3% of patients in the restrictive-fluid group and 52.6% in the standard-fluid group received albumin. Gastrointestinal focus of infection and higher doses of norepinephrine were most strongly associated with albumin use (subgroup with highest quartile of norepinephrine doses, hazard ratio (HR) 2.58, 95% CI 1.89 to 3.53). HRs for associations between site and albumin use ranged from 0.11 (95% CI 0.05 to 0.26) to 1.70 (95% CI 1.06 to 2.74); test for overall effect of site: p <.001. Conclusions: In adults with septic shock, gastrointestinal focus of infection and higher doses of norepinephrine at baseline were associated with albumin use, which also varied substantially between sites.

Published
2024

10. Restrictive versus standard IV fluid therapy in adult ICU patients with septic shock—Bayesian analyses of the CLASSIC trial

Author

Sivapalan, Praleene, Meyhoff, Tine Sylvest, Hjortrup, Peter Buhl, Lange, Theis, Kaas-Hansen, Benjamin Skov, Kjær, Maj Brit N., Laake, Jon Henrik, Cronhjort, Maria, Jakob, Stephan M., Cecconi, Maurizio, Nalos, Marek, Ostermann, Marlies, Malbrain, Manu L.N.G., Møller, Morten Hylander, Perner, Anders, Granholm, Anders, Sivapalan, Praleene, Meyhoff, Tine Sylvest, Hjortrup, Peter Buhl, Lange, Theis, Kaas-Hansen, Benjamin Skov, Kjær, Maj Brit N., Laake, Jon Henrik, Cronhjort, Maria, Jakob, Stephan M., Cecconi, Maurizio, Nalos, Marek, Ostermann, Marlies, Malbrain, Manu L.N.G., Møller, Morten Hylander, Perner, Anders, and Granholm, Anders

Abstract

Background The CLASSIC trial assessed the effects of restrictive versus standard intravenous (IV) fluid therapy in adult intensive care unit (ICU) patients with septic shock. This pre-planned study provides a probabilistic interpretation and evaluates heterogeneity in treatment effects (HTE). Methods We analysed mortality, serious adverse events (SAEs), serious adverse reactions (SARs) and days alive without life-support within 90 days using Bayesian models with weakly informative priors. HTE on mortality was assessed according to five baseline variables: disease severity, vasopressor dose, lactate levels, creatinine values and IV fluid volumes given before randomisation. Results The absolute difference in mortality was 0.2%-points (95% credible interval: −5.0 to 5.4; 47% posterior probability of benefit [risk difference <0.0%-points]) with restrictive IV fluid. The posterior probabilities of benefits with restrictive IV fluid were 72% for SAEs, 52% for SARs and 61% for days alive without life-support. The posterior probabilities of no clinically important differences (absolute risk difference ≤2%-points) between the groups were 56% for mortality, 49% for SAEs, 90% for SARs and 38% for days alive without life-support. There was 97% probability of HTE for previous IV fluid volumes analysed continuously, that is, potentially relatively lower mortality of restrictive IV fluids with higher previous IV fluids. No substantial evidence of HTE was found in the other analyses. Conclusion We could not rule out clinically important effects of restrictive IV fluid therapy on mortality, SAEs or days alive without life-support, but substantial effects on SARs were unlikely. IV fluids given before randomisation might interact with IV fluid strategy., Background: The CLASSIC trial assessed the effects of restrictive versus standard intravenous (IV) fluid therapy in adult intensive care unit (ICU) patients with septic shock. This pre-planned study provides a probabilistic interpretation and evaluates heterogeneity in treatment effects (HTE). Methods: We analysed mortality, serious adverse events (SAEs), serious adverse reactions (SARs) and days alive without life-support within 90 days using Bayesian models with weakly informative priors. HTE on mortality was assessed according to five baseline variables: disease severity, vasopressor dose, lactate levels, creatinine values and IV fluid volumes given before randomisation. Results: The absolute difference in mortality was 0.2%-points (95% credible interval: −5.0 to 5.4; 47% posterior probability of benefit [risk difference <0.0%-points]) with restrictive IV fluid. The posterior probabilities of benefits with restrictive IV fluid were 72% for SAEs, 52% for SARs and 61% for days alive without life-support. The posterior probabilities of no clinically important differences (absolute risk difference ≤2%-points) between the groups were 56% for mortality, 49% for SAEs, 90% for SARs and 38% for days alive without life-support. There was 97% probability of HTE for previous IV fluid volumes analysed continuously, that is, potentially relatively lower mortality of restrictive IV fluids with higher previous IV fluids. No substantial evidence of HTE was found in the other analyses. Conclusion: We could not rule out clinically important effects of restrictive IV fluid therapy on mortality, SAEs or days alive without life-support, but substantial effects on SARs were unlikely. IV fluids given before randomisation might interact with IV fluid strategy.

Published
2024

13. Implementation and Evaluation of a 24/7 eICU (Enhanced ICU) Model of Care in Regional and Rural NSW ICUs

Author

Bhonagiri, Deepak, primary, Hillman, Ken, additional, Lakshmanan, Ramanthan, additional, Shah, Umesh, additional, Harrison, Reema, additional, Ali, Irshad, additional, Nalos, Marek, additional, Sharma, Anurag, additional, parr, michael, additional, Lombardo, Lein, additional, pervez-Iqbal, Maha, additional, Singh, Florence, additional, Descaller, Joseph, additional, Featon, Karen, additional, Jones, Peta, additional, Varghese, Sobha, additional, Pulletz, Mark, additional, Gray, Nicole, additional, Hangar, Gail, additional, chen, Jack, additional, and Andersen, Janice, additional

Published
2023
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15. Albumin administration in septic shock—Protocol for post‐hoc analyses of data from a multicentre RCT

Author

Meyhoff, Tine Sylvest, primary, Granholm, Anders, additional, Hjortrup, Peter Buhl, additional, Sivapalan, Praleene, additional, Lange, Theis, additional, Laake, Jon Henrik, additional, Cronhjort, Maria, additional, Jakob, Stephan M., additional, Cecconi, Maurizio, additional, Nalos, Marek, additional, Ostermann, Marlies, additional, Malbrain, Manu L. N. G., additional, Møller, Morten Hylander, additional, and Perner, Anders, additional

Published
2023
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16. Albumin administration in septic shock-Protocol for post-hoc analyses of data from a multicentre RCT

Author

Meyhoff, Tine Sylvest, Granholm, Anders, Hjortrup, Peter Buhl, Sivapalan, Praleene, Lange, Theis, Laake, Jon Henrik, Cronhjort, Maria, Jakob, Stephan M, Cecconi, Maurizio, Nalos, Marek, Ostermann, Marlies, Malbrain, Manu L N G, Møller, Morten Hylander, and Perner, Anders

Subjects
Anesthesiology and Pain Medicine, 610 Medicine & health, General Medicine
Abstract

BACKGROUND Intravenous (IV) albumin is suggested for patients with septic shock who have received large amounts of IV crystalloids; a conditional recommendation based on moderate certainty of evidence. Clinical variation in the administration of IV albumin in septic shock may exist according to patient characteristics and location. METHODS This is a protocol and statistical analysis plan for a post-hoc secondary study of the Conservative versus Liberal Approach to Fluid Therapy of Septic Shock in Intensive Care (CLASSIC) RCT of 1554 adult ICU patients with septic shock. We will assess if specific baseline characteristics or trial site are associated with the administration of IV albumin during ICU stay using Cox models with competing events. All models will be adjusted for the treatment allocation in CLASSIC (restrictive vs. standard IV fluid), and all analyses will consider competing events (death, ICU discharge and loss-to-follow-up). We will present results as hazard ratios with 95% confidence intervals and p-values for the associations of baseline characteristics or site with IV albumin administration. Between-group differences (interactions) will be assessed using p-values from likelihood ratio tests. All results will be considered exploratory only. DISCUSSION This secondary study of the CLASSIC RCT may yield important insight into potential practice variation in the administration of albumin in septic shock.

Published
2023

17. Long-term effects of restriction of intravenous fluid in adult ICU patients with septic shock

Author

Kjær, Maj-Brit Nørregaard, primary, Meyhoff, Tine Sylvest, additional, Sivapalan, Praleene, additional, Granholm, Anders, additional, Hjortrup, Peter Buhl, additional, Madsen, Martin Bruun, additional, Møller, Morten Hylander, additional, Egerod, Ingrid, additional, Wetterslev, Jørn, additional, Lange, Theis, additional, Cronhjort, Maria, additional, Laake, Jon Henrik, additional, Jakob, Stephan M., additional, Nalos, Marek, additional, Ostermann, Marlies, additional, Gould, Doug, additional, Cecconi, Maurizio, additional, Malbrain, Manu L. N. G., additional, Ahlstedt, Christian, additional, Kiel, Louise Bendix, additional, Bestle, Morten H, additional, Nebrich, Lars, additional, Hildebrandt, Thomas, additional, Russell, Lene, additional, Vang, Marianne, additional, Lindhart, Michael, additional, Søllling, Christoffer, additional, Brøchner, Anne Craveiro, additional, Krag, Mette, additional, Pfortmueller, Carmen, additional, Kriz, Miroslav, additional, Siegemund, Martin, additional, Albano, Giovanni, additional, Aagaard, Søren Rosborg, additional, Bundgaard, Helle, additional, Crone, Vera, additional, Wichmann, Sine, additional, Johnstad, Bror, additional, Martin, Yvonne Karin, additional, Seidel, Philipp, additional, Mårtensson, Johan, additional, Hollenberg, Jacob, additional, Witstrand, Mats, additional, Donati, Abele, additional, Barbara, Enrico, additional, Karvunidis, Thomas, additional, Hollinger, Alexa, additional, Carsetti, Andrea, additional, Lumlertgul, Nuttha, additional, Joelsson-Alm, Eva, additional, Lambiris, Nikolas, additional, Aslam, Tayyba Naz, additional, Friberg, Fredrik Femtehjell, additional, Vesterlund, Gitte Kingo, additional, Mortensen, Camilla Bekker, additional, Vestergaard, Stine Rom, additional, Caspersen, Sidsel Fjordbak, additional, Jensen, Diana Bertelsen, additional, Brorup, Morten, additional, Rasmussen, Bodil Steen, additional, and Perner, Anders, additional

Published
2023
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19. Long-term effects of restriction of intravenous fluid in adult ICU patients with septic shock

Author

Kjær, Maj Brit Nørregaard, Meyhoff, Tine Sylvest, Sivapalan, Praleene, Granholm, Anders, Hjortrup, Peter Buhl, Madsen, Martin Bruun, Møller, Morten Hylander, Egerod, Ingrid, Wetterslev, Jørn, Lange, Theis, Cronhjort, Maria, Laake, Jon Henrik, Jakob, Stephan M., Nalos, Marek, Ostermann, Marlies, Gould, Doug, Cecconi, Maurizio, Malbrain, Manu L.N.G., Ahlstedt, Christian, Kiel, Louise Bendix, Bestle, Morten H., Nebrich, Lars, Hildebrandt, Thomas, Russell, Lene, Vang, Marianne, Rasmussen, Michael Lindhart, Sølling, Christoffer, Brøchner, Anne Craveiro, Krag, Mette, Pfortmueller, Carmen, Kriz, Miroslav, Siegemund, Martin, Albano, Giovanni, Aagaard, Søren Rosborg, Bundgaard, Helle, Crone, Vera, Wichmann, Sine, Johnstad, Bror, Martin, Yvonne Karin, Seidel, Philipp, Mårtensson, Johan, Hollenberg, Jacob, Wistrand, Mats, Donati, Abele, Barbara, Enrico, Karvunidis, Thomas, Hollinger, Alexa, Carsetti, Andrea, Lumlertgul, Nuttha, Joelsson-Alm, Eva, Lambiris, Nikolas, Aslam, Tayyba Naz, Friberg, Fredrik Femtehjell, Vesterlund, Gitte Kingo, Mortensen, Camilla Bekker, Vestergaard, Stine Rom, Caspersen, Sidsel Fjordbak, Jensen, Diana Bertelsen, Borup, Morten, Rasmussen, Bodil Steen, Perner, Anders, Kjær, Maj Brit Nørregaard, Meyhoff, Tine Sylvest, Sivapalan, Praleene, Granholm, Anders, Hjortrup, Peter Buhl, Madsen, Martin Bruun, Møller, Morten Hylander, Egerod, Ingrid, Wetterslev, Jørn, Lange, Theis, Cronhjort, Maria, Laake, Jon Henrik, Jakob, Stephan M., Nalos, Marek, Ostermann, Marlies, Gould, Doug, Cecconi, Maurizio, Malbrain, Manu L.N.G., Ahlstedt, Christian, Kiel, Louise Bendix, Bestle, Morten H., Nebrich, Lars, Hildebrandt, Thomas, Russell, Lene, Vang, Marianne, Rasmussen, Michael Lindhart, Sølling, Christoffer, Brøchner, Anne Craveiro, Krag, Mette, Pfortmueller, Carmen, Kriz, Miroslav, Siegemund, Martin, Albano, Giovanni, Aagaard, Søren Rosborg, Bundgaard, Helle, Crone, Vera, Wichmann, Sine, Johnstad, Bror, Martin, Yvonne Karin, Seidel, Philipp, Mårtensson, Johan, Hollenberg, Jacob, Wistrand, Mats, Donati, Abele, Barbara, Enrico, Karvunidis, Thomas, Hollinger, Alexa, Carsetti, Andrea, Lumlertgul, Nuttha, Joelsson-Alm, Eva, Lambiris, Nikolas, Aslam, Tayyba Naz, Friberg, Fredrik Femtehjell, Vesterlund, Gitte Kingo, Mortensen, Camilla Bekker, Vestergaard, Stine Rom, Caspersen, Sidsel Fjordbak, Jensen, Diana Bertelsen, Borup, Morten, Rasmussen, Bodil Steen, and Perner, Anders

Abstract

Purpose: To assess long-term outcomes of restrictive versus standard intravenous (IV) fluid therapy in adult intensive care unit (ICU) patients with septic shock included in the European Conservative versus Liberal Approach to Fluid Therapy in Septic Shock in Intensive Care (CLASSIC) trial. Methods: We conducted the pre-planned analyses of mortality, health-related quality of life (HRQoL) using EuroQol (EQ)-5D-5L index values and EQ visual analogue scale (VAS), and cognitive function using Mini Montreal Cognitive Assessment (Mini MoCA) test at 1 year. Deceased patients were assigned numerical zero for HRQoL as a state equal to death and zero for cognitive function outcomes as worst possible score, and we used multiple imputation for missing data on HRQoL and cognitive function. Results: Among 1554 randomized patients, we obtained 1-year data on mortality in 97.9% of patients, HRQoL in 91.3%, and cognitive function in 86.3%. One-year mortality was 385/746 (51.3%) in the restrictive-fluid group versus 383/767 (49.9%) in the standard-fluid group, absolute risk difference 1.5%-points [99% confidence interval (CI) − 4.8 to 7.8]. Mean differences were 0.00 (99% CI − 0.06 to 0.05) for EQ-5D-5L index values, − 0.65 for EQ VAS (− 5.40 to 4.08), and − 0.14 for Mini MoCA (− 1.59 to 1.14) for the restrictive-fluid group versus the standard-fluid group. The results for survivors only were similar in both groups. Conclusions: Among adult ICU patients with septic shock, restrictive versus standard IV fluid therapy resulted in similar survival, HRQoL, and cognitive function at 1 year, but clinically important differences could not be ruled out.

Published
2023

20. IFI27 transcription is an early predictor for COVID-19 outcomes, a multi-cohort observational study

Author

Shojaei, Maryam, Shamshirian, Amir, Monkman, James, Grice, Laura, Tran, Minh, Tan, Chin Wee, Teo, Siok Min, Rodrigues Rossi, Gustavo, McCulloch, Timothy R., Nalos, Marek, Raei, Maedeh, Razavi, Alireza, Ghasemian, Roya, Gheibi, Mobina, Roozbeh, Fatemeh, Sly, Peter D., Spann, Kirsten M., Chew, Keng Yih, Zhu, Yanshan, Xia, Yao, Wells, Timothy J., Senegaglia, Alexandra Cristina, Kuniyoshi, Carmen Lúcia, Franck, Claudio Luciano, dos Santos, Anna Flavia Ribeiro, Noronha, Lucia de, Motamen, Sepideh, Valadan, Reza, Amjadi, Omolbanin, Gogna, Rajan, Madan, Esha, Alizadeh-Navaei, Reza, Lamperti, Liliana, Zuñiga, Felipe, Nova-Lamperti, Estefania, Labarca, Gonzalo, Knippenberg, Ben, Herwanto, Velma, Wang, Ya, Phu, Amy, Chew, Tracy, Kwan, Timothy, Kim, Karan, Teoh, Sally, Pelaia, Tiana M., Kuan, Win Sen, Jee, Yvette, Iredell, Jon, O’Byrne, Ken, Fraser, John F., Davis, Melissa J., Belz, Gabrielle T., Warkiani, Majid E., Gallo, Carlos Salomon, Souza-Fonseca-Guimaraes, Fernando, Nguyen, Quan, Mclean, Anthony, Kulasinghe, Arutha, Short, Kirsty R., Tang, Benjamin, Shojaei, Maryam, Shamshirian, Amir, Monkman, James, Grice, Laura, Tran, Minh, Tan, Chin Wee, Teo, Siok Min, Rodrigues Rossi, Gustavo, McCulloch, Timothy R., Nalos, Marek, Raei, Maedeh, Razavi, Alireza, Ghasemian, Roya, Gheibi, Mobina, Roozbeh, Fatemeh, Sly, Peter D., Spann, Kirsten M., Chew, Keng Yih, Zhu, Yanshan, Xia, Yao, Wells, Timothy J., Senegaglia, Alexandra Cristina, Kuniyoshi, Carmen Lúcia, Franck, Claudio Luciano, dos Santos, Anna Flavia Ribeiro, Noronha, Lucia de, Motamen, Sepideh, Valadan, Reza, Amjadi, Omolbanin, Gogna, Rajan, Madan, Esha, Alizadeh-Navaei, Reza, Lamperti, Liliana, Zuñiga, Felipe, Nova-Lamperti, Estefania, Labarca, Gonzalo, Knippenberg, Ben, Herwanto, Velma, Wang, Ya, Phu, Amy, Chew, Tracy, Kwan, Timothy, Kim, Karan, Teoh, Sally, Pelaia, Tiana M., Kuan, Win Sen, Jee, Yvette, Iredell, Jon, O’Byrne, Ken, Fraser, John F., Davis, Melissa J., Belz, Gabrielle T., Warkiani, Majid E., Gallo, Carlos Salomon, Souza-Fonseca-Guimaraes, Fernando, Nguyen, Quan, Mclean, Anthony, Kulasinghe, Arutha, Short, Kirsty R., and Tang, Benjamin

Abstract

Purpose: Robust biomarkers that predict disease outcomes amongst COVID-19 patients are necessary for both patient triage and resource prioritisation. Numerous candidate biomarkers have been proposed for COVID-19. However, at present, there is no consensus on the best diagnostic approach to predict outcomes in infected patients. Moreover, it is not clear whether such tools would apply to other potentially pandemic pathogens and therefore of use as stockpile for future pandemic preparedness. Methods: We conducted a multi-cohort observational study to investigate the biology and the prognostic role of interferon alpha-inducible protein 27 (IFI27) in COVID-19 patients. Results: We show that IFI27 is expressed in the respiratory tract of COVID-19 patients and elevated IFI27 expression in the lower respiratory tract is associated with the presence of a high viral load. We further demonstrate that the systemic host response, as measured by blood IFI27 expression, is associated with COVID-19 infection. For clinical outcome prediction (e.g., respiratory failure), IFI27 expression displays a high sensitivity (0.95) and specificity (0.83), outperforming other known predictors of COVID-19 outcomes. Furthermore, IFI27 is upregulated in the blood of infected patients in response to other respiratory viruses. For example, in the pandemic H1N1/09 influenza virus infection, IFI27-like genes were highly upregulated in the blood samples of severely infected patients. Conclusion: These data suggest that prognostic biomarkers targeting the family of IFI27 genes could potentially supplement conventional diagnostic tools in future virus pandemics, independent of whether such pandemics are caused by a coronavirus, an influenza virus or another as yet-to-be discovered respiratory virus.

Published
2023

21. IFI27 transcription is an early predictor for COVID-19 outcomes, a multi-cohort observational study

Author

Shojaei, Maryam, primary, Shamshirian, Amir, additional, Monkman, James, additional, Grice, Laura, additional, Tran, Minh, additional, Tan, Chin Wee, additional, Teo, Siok Min, additional, Rodrigues Rossi, Gustavo, additional, McCulloch, Timothy R., additional, Nalos, Marek, additional, Raei, Maedeh, additional, Razavi, Alireza, additional, Ghasemian, Roya, additional, Gheibi, Mobina, additional, Roozbeh, Fatemeh, additional, Sly, Peter D., additional, Spann, Kirsten M., additional, Chew, Keng Yih, additional, Zhu, Yanshan, additional, Xia, Yao, additional, Wells, Timothy J., additional, Senegaglia, Alexandra Cristina, additional, Kuniyoshi, Carmen Lúcia, additional, Franck, Claudio Luciano, additional, dos Santos, Anna Flavia Ribeiro, additional, Noronha, Lucia de, additional, Motamen, Sepideh, additional, Valadan, Reza, additional, Amjadi, Omolbanin, additional, Gogna, Rajan, additional, Madan, Esha, additional, Alizadeh-Navaei, Reza, additional, Lamperti, Liliana, additional, Zuñiga, Felipe, additional, Nova-Lamperti, Estefania, additional, Labarca, Gonzalo, additional, Knippenberg, Ben, additional, Herwanto, Velma, additional, Wang, Ya, additional, Phu, Amy, additional, Chew, Tracy, additional, Kwan, Timothy, additional, Kim, Karan, additional, Teoh, Sally, additional, Pelaia, Tiana M., additional, Kuan, Win Sen, additional, Jee, Yvette, additional, Iredell, Jon, additional, O’Byrne, Ken, additional, Fraser, John F., additional, Davis, Melissa J., additional, Belz, Gabrielle T., additional, Warkiani, Majid E., additional, Gallo, Carlos Salomon, additional, Souza-Fonseca-Guimaraes, Fernando, additional, Nguyen, Quan, additional, Mclean, Anthony, additional, Kulasinghe, Arutha, additional, Short, Kirsty R., additional, and Tang, Benjamin, additional

Published
2023
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23. Restriction of Intravenous Fluid in ICU Patients with Septic Shock

Author

Meyhoff, Tine S., Hjortrup, Peter B., Wetterslev, Jørn, Sivapalan, Praleene, Laake, Jon H., Cronhjort, Maria, Jakob, Stephan M., Cecconi, Maurizio, Nalos, Marek, Ostermann, Marlies, Malbrain, Manu, Pettilä, Ville, Møller, Morten H., Kjær, Maj-Brit N., Lange, Theis, Overgaard-Steensen, Christian, Brand, Björn A., Winther-Olesen, Marie, White, Jonathan O., Quist, Lars, Westergaard, Bo, Jonsson, Andreas B., Hjortsø, Carl J.S., Meier, Nick, Jensen, Thomas S., Engstrøm, Janus, Nebrich, Lars, Andersen-Ranberg, Nina C., Jensen, Jacob V., Joseph, Neeliya A., Poulsen, Lone M., Herløv, Louise S., Sølling, Christoffer G., Pedersen, Susan K., Knudsen, Kurt K., Straarup, Therese S., Vang, Marianne L., Bundgaard, Helle, Rasmussen, B. S., Aagaard, S. R., Hildebrandt, Thomas, Russell, Lene, Bestle, Morten H., Schønemann-Lund, Martin, Brøchner, Anne C., Elvander, Claes F., Hoffmann, Søren K.L., Rasmussen, Michael L., Martin, Yvonne K., Friberg, Fredrik F., Seter, Herman, Aslam, Tayyba N., Ådnøy, Sigrid, Seidel, Philipp, Strand, Kristian, Johnstad, Bror, Joelsson-Alm, Eva, Christensen, Jens, Ahlstedt, Christian, Pfortmueller, Carmen A., Siegemund, Martin, Greco, Massimiliano, Raděj, Jaroslav, Kříž, Miroslav, Gould, Doug W., Rowan, Kathy M., Mouncey, Paul R., Perner, Anders, Siegumfeldt, Rine Moulvad, and Vestergaard, Stine Rom

Subjects
PROTOCOL, Adult, SEPSIS, RESUSCITATION, MORTALITY, Critical Care/methods, ADULTS, General Medicine, Intensive Care Units, TRIALS, MANAGEMENT, Humans, Administration, Intravenous, 610 Medicine & health, Shock, Septic/mortality, Fluid Therapy/adverse effects
Abstract

BACKGROUND: Intravenous fluids are recommended for the treatment of patients who are in septic shock, but higher fluid volumes have been associated with harm in patients who are in the intensive care unit (ICU).METHODS: In this international, randomized trial, we assigned patients with septic shock in the ICU who had received at least 1 liter of intravenous fluid to receive restricted intravenous fluid or standard intravenous fluid therapy; patients were included if the onset of shock had been within 12 hours before screening. The primary outcome was death from any cause within 90 days after randomization.RESULTS: We enrolled 1554 patients; 770 were assigned to the restrictive-fluid group and 784 to the standard-fluid group. Primary outcome data were available for 1545 patients (99.4%). In the ICU, the restrictive-fluid group received a median of 1798 ml of intravenous fluid (interquartile range, 500 to 4366); the standard-fluid group received a median of 3811 ml (interquartile range, 1861 to 6762). At 90 days, death had occurred in 323 of 764 patients (42.3%) in the restrictive-fluid group, as compared with 329 of 781 patients (42.1%) in the standard-fluid group (adjusted absolute difference, 0.1 percentage points; 95% confidence interval [CI], -4.7 to 4.9; P = 0.96). In the ICU, serious adverse events occurred at least once in 221 of 751 patients (29.4%) in the restrictive-fluid group and in 238 of 772 patients (30.8%) in the standard-fluid group (adjusted absolute difference, -1.7 percentage points; 99% CI, -7.7 to 4.3). At 90 days after randomization, the numbers of days alive without life support and days alive and out of the hospital were similar in the two groups.CONCLUSIONS: Among adult patients with septic shock in the ICU, intravenous fluid restriction did not result in fewer deaths at 90 days than standard intravenous fluid therapy. (Funded by the Novo Nordisk Foundation and others; CLASSIC ClinicalTrials.gov number, NCT03668236.).

Published
2022

24. Restriction of Intravenous Fluid in ICU Patients with Septic Shock

Author

Meyhoff, Tine S., primary, Hjortrup, Peter B., additional, Wetterslev, Jørn, additional, Sivapalan, Praleene, additional, Laake, Jon H., additional, Cronhjort, Maria, additional, Jakob, Stephan M., additional, Cecconi, Maurizio, additional, Nalos, Marek, additional, Ostermann, Marlies, additional, Malbrain, Manu, additional, Pettilä, Ville, additional, Møller, Morten H., additional, Kjær, Maj-Brit N., additional, Lange, Theis, additional, Overgaard-Steensen, Christian, additional, Brand, Björn A., additional, Winther-Olesen, Marie, additional, White, Jonathan O., additional, Quist, Lars, additional, Westergaard, Bo, additional, Jonsson, Andreas B., additional, Hjortsø, Carl J.S., additional, Meier, Nick, additional, Jensen, Thomas S., additional, Engstrøm, Janus, additional, Nebrich, Lars, additional, Andersen-Ranberg, Nina C., additional, Jensen, Jacob V., additional, Joseph, Neeliya A., additional, Poulsen, Lone M., additional, Herløv, Louise S., additional, Sølling, Christoffer G., additional, Pedersen, Susan K., additional, Knudsen, Kurt K., additional, Straarup, Therese S., additional, Vang, Marianne L., additional, Bundgaard, Helle, additional, Rasmussen, Bodil S., additional, Aagaard, Søren R., additional, Hildebrandt, Thomas, additional, Russell, Lene, additional, Bestle, Morten H., additional, Schønemann-Lund, Martin, additional, Brøchner, Anne C., additional, Elvander, Claes F., additional, Hoffmann, Søren K.L., additional, Rasmussen, Michael L., additional, Martin, Yvonne K., additional, Friberg, Fredrik F., additional, Seter, Herman, additional, Aslam, Tayyba N., additional, Ådnøy, Sigrid, additional, Seidel, Philipp, additional, Strand, Kristian, additional, Johnstad, Bror, additional, Joelsson-Alm, Eva, additional, Christensen, Jens, additional, Ahlstedt, Christian, additional, Pfortmueller, Carmen A., additional, Siegemund, Martin, additional, Greco, Massimiliano, additional, Raděj, Jaroslav, additional, Kříž, Miroslav, additional, Gould, Doug W., additional, Rowan, Kathy M., additional, Mouncey, Paul R., additional, and Perner, Anders, additional

Published
2022
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26. How much do we throw away in the intensive care unit? An observational point prevalence study of Australian and New Zealand ICUs

Author

Anstey, Matthew H., Trent, Louise, Bhonagiri, Deepak, Hammond, Naomi E., Knowles, Serena, McGain, Forbes, Hammond, Naomi, Knowles, Serena, Freeman-Sanderson, Amy, Ganu, Subodh, Howe, Belinda, Litton, Ed, Mackle, Diane, Saxena, Manoj, Seppelt, Ian, Towns, Miriam, Yarad, Elizabeth, Hammond, Knowles, Serena, Gao, Annie, Li, Yang, Myburgh, John, Seppelt, Ian, Nangla, Conrad, Butt, Fatima, Duke, Graeme, Hunter, Stephanie, Evans, Julie, Parker, Dianne, Loughnan, Clare, Thomas, Blessy, Gilder, Eileen, Robertson, Melissa, McMahon, Ellie, Ali, Farisha, Cowdrey, Keri-Anne, McArthur, Colin, Chen, Yan, Simmonds, Catherine, McConnochie, Rachael, O'Connor, Caroline, El-Khawas, Khaled, Hill, Dianne, Cattigan, Claire, Horton, Michelle, Trickey, Jemma, Knott, Cameron, Smith, Julie, Boschert, Catherine, Sara, Treena, Nand, Kiran, Duke, Graeme, Hunter, Stephanie, Evans, Julie, Parker, Dianne, Loughnan, Clare, Thomas, Blessy, Ramanan, Mahesh, Marella, Prashanti, Affleck, Julia, Simpson, Shannon, Ellem, Katrina, McKenna, Toni, Nourse, Mary, Leung, Kristine, Edmunds, Tash, McDonald, Bree, Mehrtens, Jan, Cross, Rosalba, Wong, Helen, Twardowski, Pawel, France, Dawn, Hanlon, Gabrielle, Barrett, Jonathan, Palermo, Annamaria, Pellicano, Susan, Eroglu, Ege, Bihari, Shailesh, Brown, Julia, Grear, Laura, Jin, Xia, French, Craig, Bates, Samantha, Towns, Miriam, Marshall, Fiona, McEldrew, Rebecca, McCullough, James, Tallott, Mandy, Gough, Maimoonbe, Nalos, Marek, Younger, Laura, Krishnamurphy, Ravi, Trent, Louise, How, Janet, Stuart, Anne, Chadwick, Llesley, Bhadange, Neeraj, Tyler, Steven, Sosnowski, Kellie, Morrison, Lynette, Sutton, Joanne, Soar, Natalie, Lee, David, Duke, Graeme, Hunter, Stephanie, Evans, Julie, Parker, Dianne, Loughnan, Clare, Doyle, Marina, Jongebloed, Katherine, Finnis, Mackenzie, Wilson, Jane, Williams, Tony, Song, Rima, Lai, Vivian, Girijadevi, Dinu, Habraken, Hannah, Browne, Alex, Koelle, Jette, McNab, Charlotte, Masters, Kristy, Gresham, Rebecca, Lowrey, Julie, Whitehead, Christina, Liang, Janet, Harward, Meg, Jones, Cassie, Peake, Sandra, Williams, Tricia, Kurenda, Catherine, Tabah, Alexis, Duroux, Maree, Warhurst, Timothy, Ratcliffe, Megan, Pollock, Hamish, Baker, Stuart, Sonawane, Ravikiran, O'Connor, Stephanie, Brown, Nerissa, Glasby, Kathleen, Rivett, Justine, Campbell, Lewis, Tabuzo, Vera, Smyth, Kirsty, Yarad, Elizabeth, Bass, Frances, Hammond, Naomi, O'Connor, Anne, Leonard, Anton, Waterson, Sharon, Coles, Jennifer, Buhr, Heidi, Newman, Duncan, Boorawong, Piyaporn, Bregolin, Vanessa, Yun, Ji-Hyun, Anstey, Matthew, Rock, Lara, Endemann, Anthadene, Lo, Wei, Ferrier, Janet, Palermo, Annamaria, Reynolds, Claire, Santamaria, John, Holmes, Jennifer, Beca, John, Sherring, Claire, Garrett, Peter, Murray, Lauren, Brailsford, Jane, French, Craig, Bates, Samantha, Towns, Miriam, Marshall, Fiona, McEldrew, Rebecca, Browne, Troy, Goodson, Jennifer, Udy, Andrew, Young, Meredith, Board, Jasmin, McCracken, Phoebe, Martin, Emma-Leah, Martynoga, Robert, Butler, Amelia, Trask, Kara, Olatunji, Shaanti, Cruz, Rhoze Sol, Cruz, Raulle Sol, Navarra, Leanlove, Delaney, Kirsha, Lesona, Eden, Young, Chelsea, Spring, Amelia, Aguilar, April, Young, Paul, and Law, Erin

Abstract

During the current COVID pandemic, waste generation has been more evident with increased use of single use masks, gowns and other personal protective equipment. We aimed to understand the scale of waste generation, recycling rates and participation in Australian and New Zealand (ANZ) ICUs.

Published
2023
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27. IFI27 transcription is an early predictor for COVID-19 outcomes; a multi-cohort observational study

Author

Shojaei, Maryam, primary, Shamshirian, Amir, additional, Monkman, James, additional, Grice, Laura, additional, Tran, Minh, additional, Tan, Chin Wee, additional, Rossi, Gustavo Rodrigues, additional, McCulloch, Timothy R., additional, Nalos, Marek, additional, Chew, Keng Yih, additional, Zhu, Yanshan, additional, Xia, Yao, additional, Wells, Timothy J., additional, Senegaglia, Alexandra Cristina, additional, Rebelatto, Carmen Lúcia Kuniyoshi, additional, Franck, Claudio Luciano, additional, dos Santos, Anna Flavia Ribeiro, additional, de Noronha, Lucia, additional, Motamen, Sepideh, additional, Valadan, Reza, additional, Amjadi, Omolbanin, additional, Gogna, Rajan, additional, Madan, Esha, additional, Alizadeh-Navaei, Reza, additional, Lamperti, Liliana, additional, Zuñiga, Felipe, additional, Nova-Lamperti, Estefania, additional, Labarca, Gonzalo, additional, Knippenberg, Ben, additional, Herwanto, Velma, additional, Wang, Ya, additional, Phu, Amy, additional, Chew, Tracy, additional, Kwan, Timothy, additional, Kim, Karan, additional, Teoh, Sally, additional, Pelaia, Tiana M, additional, Kuan, Win Sen, additional, Jee, Yvette, additional, Iredell, Jon, additional, O’Byrne, Ken, additional, Fraser, John F., additional, Davis, Melissa J., additional, Belz, Gabrielle, additional, Warkiani, Majid, additional, Gallo, Carlos Salomon, additional, Souza-Fonseca-Guimaraes, Fernando, additional, Nguyen, Quan, additional, Mclean, Anthony, additional, Kulasinghe, Arutha, additional, Short, Kirsty R., additional, and Tang, Benjamin, additional

Published
2021
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28. How often are infusion sets for central venous catheters changed in Australian and New Zealand Intensive Care Units? A point prevalence survey

Author

Anstey, Matthew H., Maxwell, Nicky, Rickard, Claire M., Hammond, Naomi E., Knowles, Serena, McGain, Forbes, Hammond, Naomi, Knowles, Serena, Freeman-Sanderson, Amy, Ganu, Subodh, Howe, Belinda, Litton, Ed, Mackle, Diane, Saxena, Manoj, Seppelt, Ian, Towns, Miriam, Yarad, Elizabeth, Hammond, Naomi, Knowles, Serena, Gao, Annie, Li, Yang, Myburgh, John, Seppelt, Ian, Nangla, Conrad, Butt, Fatima, Duke, Graeme, Hunter, Stephanie, Evans, Julie, Parker, Dianne, Loughnan, Clare, Thomas, Blessy, Gilder, Eileen, Robertson, Melissa, McMahon, Ellie, Ali, Farisha, Cowdrey, Keri-Anne, McArthur, Colin, Chen, Yan, Simmonds, Catherine, McConnochie, Rachael, O’Connor, Caroline, El-Khawas, Khaled, Hill, Dianne, Cattigan, Claire, Horton, Michelle, Trickey, Jemma, Knott, Cameron, Smith, Julie, Boschert, Catherine, Sara, Treena, Nand, Kiran, Duke, Graeme, Hunter, Stephanie, Evans, Julie, Parker, Dianne, Loughnan, Clare, Thomas, Blessy, Ramanan, Mahesh, Marella, Prashanti, Affleck, Julia, Simpson, Shannon, Ellem, Katrina, McKenna, Toni, Nourse, Mary, Leung, Kristine, Edmunds, Tash, McDonald, Bree, Mehrtens, Jan, Cross, Rosalba, Wong, Helen, Twardowski, Pawel, France, Dawn, Hanlon, Gabrielle, Barrett, Jonathan, Palermo, Annamaria, Pellicano, Susan, Eroglu, Ege, Bihari, Shailesh, Brown, Julia, Grear, Laura, Jin, Xia, French, Craig, Bates, Samantha, Towns, Miriam, Marshall, Fiona, McEldrew, Rebecca, McCullough, James, Tallott, Mandy, Gough, Maimoonbe, Nalos, Marek, Younger, Laura, Krishnamurphy, Ravi, Trent, Louise, How, Janet, Stuart, Anne, Chadwick, Llesley, Bhadange, Neeraj, Tyler, Steven, Sosnowski, Kellie, Morrison, Lynette, Sutton, Joanne, Soar, Natalie, Lee, David, Duke, Graeme, Hunter, Stephanie, Evans, Julie, Parker, Dianne, Loughnan, Clare, Doyle, Marina, Jongebloed, Katherine, Finnis, Mackenzie, Wilson, Jane, Williams, Tony, Song, Rima, Lai, Vivian, Girijadevi, Dinu, Habraken, Hannah, Browne, Alex, Koelle, Jette, McNab, Charlotte, Masters, Kristy, Gresham, Rebecca, Lowrey, Julie, Whitehead, Christina, Liang, Janet, Harward, Meg, Jones, Cassie, Peake, Sandra, Williams, Tricia, Kurenda, Catherine, Tabah, Alexis, Duroux, Maree, Warhurst, Timothy, Ratcliffe, Megan, Pollock, Hamish, Baker, Stuart, Sonawane, Ravikiran, O'Connor, Stephanie, Brown, Nerissa, Glasby, Kathleen, Rivett, Justine, Campbell, Lewis, Tabuzo, Vera, Smyth, Kirsty, Yarad, Elizabeth, Bass, Frances, Hammond, Naomi, O'Connor, Anne, Leonard, Anton, Waterson, Sharon, Coles, Jennifer, Buhr, Heidi, Newman, Duncan, Boorawong, Piyaporn, Bregolin, Vanessa, Yun, Ji-Hyun, Anstey, Matthew, Rock, Lara, Endemann, Anthadene, Lo, Wei, Ferrier, Janet, Palermo, Annamaria, Reynolds, Claire, Santamaria, John, Holmes, Jennifer, Beca, John, Sherring, Claire, Garrett, Peter, Murray, Lauren, Brailsford, Jane, French, Craig, Bates, Samantha, Towns, Miriam, Marshall, Fiona, McEldrew, Rebecca, Browne, Troy, Goodson, Jennifer, Udy, Andrew, Young, Meredith, Board, Jasmin, McCracken, Phoebe, Martin, Emma-Leah, Martynoga, Robert, Butler, Amelia, Trask, Kara, Olatunji, Shaanti, Cruz, Rhoze Sol, Cruz, Raulle Sol, Navarra, Leanlove, Delaney, Kirsha, Lesona, Eden, Young, Chelsea, Spring, Amelia, Aguilar, April, Young, Paul, and Law, Erin

Abstract

Infusion sets (comprising the tubing, measuring burettes, fluid containers, transducers) that are connected to invasive vascular devices are changed on a regular basis in an effort to reduce bacterial colonisation and bloodstream infection. There is a balance between reducing infection and creating unnecessary waste. Current evidence suggests that for central venous catheters, changing infusion sets at 7 days does not increase infection risks.

Published
2023
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29. Preferences for albumin use in adult intensive care unit patients with shock: An international survey.

Author

Sivapalan, Praleene, Ellekjaer, Karen Louise, Perner, Anders, Møller, Morten Hylander, Granholm, Anders, Grønningsæter, Lasse, Ostermann, Marlies, Sweeney, Rob Mac, Cronhjort, Maria, Hästbacka, Johanna, Pfortmueller, Carmen, De Waele, Jan, Nalos, Marek, Jovaisa, Tomas, Reintam Blaser, Annika, Cecconi, Maurizio, Ergan, Begum, Al‐Fares, Abdulrahman, Young, Paul J., and Szczeklik, Wojciech

Subjects
*INTENSIVE care patients, *ALBUMINS, *SERUM albumin, *INTENSIVE care units, *CARDIOGENIC shock
Abstract

Introduction Methods Results Conclusions Use of albumin is suggested for some patients with shock, but preferences for its use may vary among intensive care unit (ICU) physicians.We conducted an international online survey of ICU physicians with 20 questions about their use of albumin and their opinion towards a randomised trial among adults with shock comparing the use versus no use of albumin.A total of 1248 respondents participated, with a mean response rate of 37%, ranging from 18% to 75% across 21 countries. Respondents mainly worked in mixed ICUs and 92% were specialists in intensive care medicine. The reported use of albumin in general shock varied as 18% reported ‘almost never’, 22% ‘rarely’, 34% ‘occasionally’, 22% ‘frequently’ and 4% ‘almost always’ using albumin. In septic shock, 19% reported ‘almost never’, 22% ‘rarely’, 29% ‘occasionally’, 22% ‘frequently’ and 7% ‘almost always’ using albumin. Physicians’ preferences were more consistent for haemorrhagic‐ and cardiogenic shock, with more than 45% reporting ‘almost never’ using albumin. While the reported use of albumin for other purposes than resuscitation was infrequent (40%–85% reported ‘almost never’ for five other indications), the most frequent other indications were low serum albumin levels and improvement of the efficacy of diuretics. Most respondents (93%) would randomise adult ICU patients with shock to a trial of albumin versus no albumin.In this international survey, the reported preferences for the use of albumin in adult ICU patients with shock varied considerably among surveyed ICU physicians. The support for a future randomised trial was high. [ABSTRACT FROM AUTHOR]

Published
2024
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30. Albumin use in patients with septic shock-Post-hoc analyses of an international randomised fluid trial.

Author

Meyhoff TS, Granholm A, Hjortrup PB, Sivapalan P, Lange T, Laake JH, Cronhjort M, Jakob SM, Cecconi M, Nalos M, Ostermann M, Malbrain MLNG, Møller MH, and Perner A

Subjects
Adult, Humans, Norepinephrine therapeutic use, Albumins therapeutic use, Fluid Therapy adverse effects, Shock, Septic drug therapy, Shock, Septic complications, Sepsis drug therapy, Sepsis etiology
Abstract

Background: Albumin administration is suggested in patients with sepsis and septic shock who have received large volumes of crystalloids. Given lack of firm evidence, clinical practice variation may exist. To address this, we investigated if patient characteristics or trial site were associated with albumin use in septic shock., Methods: We conducted a post-hoc study of the CLASSIC international, randomised clinical trial of fluid volumes in septic shock. Associations between selected baseline variables and trial site with albumin use during ICU stay were assessed in Cox models considering death, ICU discharge, and loss-to-follow-up as competing events. Baseline variables were first assessed individually, adjusted for treatment allocation (restrictive vs. standard IV fluid), and then adjusted for allocation and the other baseline variables. Site was assessed in a model adjusted for allocation and baseline variables., Results: We analysed 1541 of 1554 patients randomised in CLASSIC (99.2%). During ICU stay, 36.3% of patients in the restrictive-fluid group and 52.6% in the standard-fluid group received albumin. Gastrointestinal focus of infection and higher doses of norepinephrine were most strongly associated with albumin use (subgroup with highest quartile of norepinephrine doses, hazard ratio (HR) 2.58, 95% CI 1.89 to 3.53). HRs for associations between site and albumin use ranged from 0.11 (95% CI 0.05 to 0.26) to 1.70 (95% CI 1.06 to 2.74); test for overall effect of site: p < .001., Conclusions: In adults with septic shock, gastrointestinal focus of infection and higher doses of norepinephrine at baseline were associated with albumin use, which also varied substantially between sites., (© 2023 Acta Anaesthesiologica Scandinavica Foundation.)

Published
2024
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31. Restrictive versus standard IV fluid therapy in adult ICU patients with septic shock-Bayesian analyses of the CLASSIC trial.

Author

Sivapalan P, Meyhoff TS, Hjortrup PB, Lange T, Kaas-Hansen BS, Kjaer MN, Laake JH, Cronhjort M, Jakob SM, Cecconi M, Nalos M, Ostermann M, Malbrain MLNG, Møller MH, Perner A, and Granholm A

Subjects
Adult, Humans, Bayes Theorem, Fluid Therapy, Intensive Care Units, Randomized Controlled Trials as Topic, Shock, Septic therapy
Abstract

Background: The CLASSIC trial assessed the effects of restrictive versus standard intravenous (IV) fluid therapy in adult intensive care unit (ICU) patients with septic shock. This pre-planned study provides a probabilistic interpretation and evaluates heterogeneity in treatment effects (HTE)., Methods: We analysed mortality, serious adverse events (SAEs), serious adverse reactions (SARs) and days alive without life-support within 90 days using Bayesian models with weakly informative priors. HTE on mortality was assessed according to five baseline variables: disease severity, vasopressor dose, lactate levels, creatinine values and IV fluid volumes given before randomisation., Results: The absolute difference in mortality was 0.2%-points (95% credible interval: -5.0 to 5.4; 47% posterior probability of benefit [risk difference <0.0%-points]) with restrictive IV fluid. The posterior probabilities of benefits with restrictive IV fluid were 72% for SAEs, 52% for SARs and 61% for days alive without life-support. The posterior probabilities of no clinically important differences (absolute risk difference ≤2%-points) between the groups were 56% for mortality, 49% for SAEs, 90% for SARs and 38% for days alive without life-support. There was 97% probability of HTE for previous IV fluid volumes analysed continuously, that is, potentially relatively lower mortality of restrictive IV fluids with higher previous IV fluids. No substantial evidence of HTE was found in the other analyses., Conclusion: We could not rule out clinically important effects of restrictive IV fluid therapy on mortality, SAEs or days alive without life-support, but substantial effects on SARs were unlikely. IV fluids given before randomisation might interact with IV fluid strategy., (© 2023 The Authors. Acta Anaesthesiologica Scandinavica published by John Wiley & Sons Ltd on behalf of Acta Anaesthesiologica Scandinavica Foundation.)

Published
2024
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