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2. 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
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3. Restrictive fluids versus standard care in adults with sepsis in the emergency department ( REFACED ): A multicenter, randomized feasibility trial

Author

Jessen, Marie K., primary, Andersen, Lars W., additional, Thomsen, Marie‐Louise H., additional, Kristensen, Peter, additional, Hayeri, Wazhma, additional, Hassel, Ranva E., additional, Messerschmidt, Tina G., additional, Sølling, Christoffer G., additional, Perner, Anders, additional, Petersen, Jens Aage K., additional, and Kirkegaard, Hans, additional

Published
2022
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4. Long‐term cognitive and functional status in Danish ICU patients with COVID ‐19

Author

Weihe, Sarah, primary, Mortensen, Camilla B., additional, Haase, Nicolai, additional, Andersen, Lars P. K., additional, Mohr, Thomas, additional, Siegel, Hanna, additional, Ibsen, Michael, additional, Jørgensen, Vibeke R. L., additional, Buck, David L., additional, Pedersen, Helle B. S., additional, Pedersen, Henrik P., additional, Iversen, Susanne, additional, Ribergaard, Niels, additional, Rasmussen, Bodil S., additional, Winding, Robert, additional, Espelund, Ulrick S., additional, Bundgaard, Helle, additional, Sølling, Christoffer G., additional, Christensen, Steffen, additional, Garcia, Ricardo S., additional, Brøchner, Anne C., additional, Michelsen, Jens, additional, Michagin, George, additional, Kirkegaard, Lynge, additional, Perner, Anders, additional, Mathiesen, Ole, additional, and Poulsen, Lone M., additional

Published
2022
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5. 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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6. Restrictive fluids versus standard care in adults with sepsis in the emergency department (REFACED):A multicenter, randomized feasibility trial

Author

Jessen, Marie K., Andersen, Lars W., Thomsen, Marie-Louise H., Kristensen, Peter, Hayeri, Wazhma, Hassel, Ranva E., Messerschmidt, Tina G., Sølling, Christoffer G., Perner, Anders, Petersen, Jens Aage K., Kirkegaard, Hans, Jessen, Marie K., Andersen, Lars W., Thomsen, Marie-Louise H., Kristensen, Peter, Hayeri, Wazhma, Hassel, Ranva E., Messerschmidt, Tina G., Sølling, Christoffer G., Perner, Anders, Petersen, Jens Aage K., and Kirkegaard, Hans

Abstract

Background: Fluid treatment in sepsis is a challenge and clinical equipoise exists regarding intravenous (IV) volumes. We aimed to determine whether a 24-h protocol restricting IV fluid was feasible in adult patients with sepsis without shock presenting to the emergency department (ED). Methods: The REFACED Sepsis trial is an investigator-initiated, multicenter, randomized, open-label, feasibility trial, assigning sepsis patients without shock to 24 h of restrictive, crystal IV fluid administration or standard care. In the IV fluid restriction group fluid boluses were only permitted if predefined criteria for hypoperfusion occurred. Standard care was at the discretion of the treating team. The primary outcome was total IV crystalloid fluid volumes at 24 h after randomization. Secondary outcomes included total fluid volumes, feasibility measures, and patient-centered outcomes. Results: We included 123 patients (restrictive 61 patients and standard care 62 patients) in the primary analysis. A total of 32% (95% confidence interval [CI] 28%–37%) of eligible patients meeting all inclusion criteria and no exclusion criteria were included. At 24 h, the mean (±SD) IV crystalloid fluid volumes were 562 (±1076) ml versus 1370 (±1438) ml in the restrictive versus standard care group (mean difference –801 ml, 95% CI −1257 to −345 ml, p = 0.001). Protocol violations occurred in 21 (34%) patients in the fluid-restrictive group. There were no differences between groups in adverse events, use of mechanical ventilation or vasopressors, acute kidney failure, length of stay, or mortality. Conclusions: A protocol restricting IV crystalloid fluids in ED patients with sepsis reduced 24-h fluid volumes compared to standard care. A future trial powered toward patient-centered outcomes appears feasible.

Published
2022

7. Long-term cognitive and functional status in Danish ICU patients with COVID-19

Author

Weihe, Sarah, Mortensen, Camilla B., Haase, Nicolai, Andersen, Lars P.K., Mohr, Thomas, Siegel, Hanna, Ibsen, Michael, Jørgensen, Vibeke R.L., Buck, David L., Pedersen, Helle B.S., Pedersen, Henrik P., Iversen, Susanne, Ribergaard, Niels, Rasmussen, Bodil S., Winding, Robert, Espelund, Ulrick S., Bundgaard, Helle, Sølling, Christoffer G., Christensen, Steffen, Garcia, Ricardo S., Brøchner, Anne C., Michelsen, Jens, Michagin, George, Kirkegaard, Lynge, Perner, Anders, Mathiesen, Ole, Poulsen, Lone M., Weihe, Sarah, Mortensen, Camilla B., Haase, Nicolai, Andersen, Lars P.K., Mohr, Thomas, Siegel, Hanna, Ibsen, Michael, Jørgensen, Vibeke R.L., Buck, David L., Pedersen, Helle B.S., Pedersen, Henrik P., Iversen, Susanne, Ribergaard, Niels, Rasmussen, Bodil S., Winding, Robert, Espelund, Ulrick S., Bundgaard, Helle, Sølling, Christoffer G., Christensen, Steffen, Garcia, Ricardo S., Brøchner, Anne C., Michelsen, Jens, Michagin, George, Kirkegaard, Lynge, Perner, Anders, Mathiesen, Ole, and Poulsen, Lone M.

Abstract

Background: ICU admission due to COVID-19 may result in cognitive and physical impairment. We investigated the long-term cognitive and physical status of Danish ICU patients with COVID-19. Methods: We included all patients with COVID-19 admitted to Danish ICUs between March 10 and May 19, 2020. Patients were the contacted prospectively at 6 and 12 months for follow-up. Our primary outcomes were cognitive function and frailty at 6 and 12 months after ICU admission, estimated by the Mini Montreal Cognitive Assessment, and the Clinical Frailty Scale. Secondary outcomes were 6- and 12-month mortality, health-related quality of life (HRQoL) assessed by EQ-5D-5L, functional status (Barthel activities of daily living and Lawton–Brody instrumental activities of daily living), and fatigue (Fatigue Assessment Scale). The study had no information on pre-ICU admission status for the participants. Results: A total of 326 patients were included. The 6- and 12-month mortality was 37% and 38%, respectively. Among the 204 six-month survivors, 105 (51%) participated in the 6-month follow-up; among the 202 twelve-month survivors, 95 (47%) participated in the 12-month follow-up. At 6 months, cognitive scores indicated impairment for 26% (95% confidence interval [CI], 11.4–12.4) and at 12 months for 17% (95% CI, 12.0–12.8) of participants. Frailty was indicated in 20% (95% CI, 3.4–3.9) at 6 months, and for 18% (95% CI, 3.3–3.8) at 12 months. Fatigue was reported by 52% at 6 months, and by 47% at 12 months. For HRQoL, moderate, severe, or extreme health problems were reported by 28% at 6 months, and by 25% at 12 months. Conclusion: Long-term cognitive, functional impairment was found in up to one in four of patients surviving intensive care for COVID-19. Fatigue was present in nearly half the survivors at both 6 and 12 months. However, pre-ICU admission status of the patients was unknown.

Published
2022

8. Oxygenation targets in ICU patients with COVID-19:a post-hoc sub-group analysis of the HOT-ICU trial

Author

Rasmussen, Bodil S., Klitgaard, Thomas L., Perner, Anders, Brand, Björn A., Hildebrandt, Thomas, Siegemund, Martin, Hollinger, Alexa, Aagaard, Søren R., Bestle, Morten H., Marcussen, Klaus V., Brøchner, Anne C., Sølling, Christoffer G., Poulsen, Lone M., Laake, Jon H., Aslam, Tayyba N., Bäcklund, Minna, Okkonen, Marjatta, Morgan, Matthew, Sharman, Mike, Lange, Theis, Wetterslev, Jørn, Schjørring, Olav L., Rasmussen, Bodil S., Klitgaard, Thomas L., Perner, Anders, Brand, Björn A., Hildebrandt, Thomas, Siegemund, Martin, Hollinger, Alexa, Aagaard, Søren R., Bestle, Morten H., Marcussen, Klaus V., Brøchner, Anne C., Sølling, Christoffer G., Poulsen, Lone M., Laake, Jon H., Aslam, Tayyba N., Bäcklund, Minna, Okkonen, Marjatta, Morgan, Matthew, Sharman, Mike, Lange, Theis, Wetterslev, Jørn, and Schjørring, Olav L.

Abstract

Background Supplemental oxygen is the key intervention for severe and critical COVID-19 patients. With the unstable supplies of oxygen in many countries it is important to define the lowest safe dosage. Methods In spring 2020, 110 COVID-19 patients were enrolled as part of the Handling Oxygenation Targets in the ICU trial (HOT-ICU). Patients were allocated within 12 hours of ICU admission. Oxygen therapy was titrated to a partial pressure of arterial oxygen (PaO2) of 8 kPa (lower oxygenation group) or a PaO2 of 12 kPa (higher oxygenation group) during ICU stay up to 90 days. We report key outcomes at 90 days for the sub-group of COVID-19 patients. Results At 90 days, 22 of 54 patients (40.7 in the lower oxygenation group and 23 of 55 patients (41.8 in the higher oxygenation group had died (adjusted risk ratio: 0.87; 95 0.58 - 1.32). Percentage of days alive without life support was significantly higher in the lower oxygenation group (p=0.03). Numbers of severe ischemic events were low with no difference between the two groups. Proning and inhaled vasodilators were used more frequently, and the positive end-expiratory pressure was higher in the higher oxygenation group. Tests for interactions with the results of the remaining HOT-ICU population were insignificant. Conclusions Targeting a PaO2 of 8 kPa may be beneficial in ICU patients with COVID-19. These results come with uncertainty due to the low number of patients in this unplanned sub-group analysis, and insignificant tests for interaction with the main HOT-ICU trial.

Published
2022

9. Oxygenation targets in ICU patients with COVID‐19: A post hoc subgroup analysis of the HOT‐ICU trial

Author

Rasmussen, Bodil S., primary, Klitgaard, Thomas L., additional, Perner, Anders, additional, Brand, Björn A., additional, Hildebrandt, Thomas, additional, Siegemund, Martin, additional, Hollinger, Alexa, additional, Aagaard, Søren R., additional, Bestle, Morten H., additional, Marcussen, Klaus V., additional, Brøchner, Anne C., additional, Sølling, Christoffer G., additional, Poulsen, Lone M., additional, Laake, Jon H., additional, Aslam, Tayyba N., additional, Bäcklund, Minna, additional, Okkonen, Marjatta, additional, Morgan, Matthew, additional, Sharman, Mike, additional, Lange, Theis, additional, Wetterslev, Jørn, additional, and Schjørring, Olav L., additional

Published
2021
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10. Lower or Higher Oxygenation Targets for Acute Hypoxemic Respiratory Failure

Author

Schjørring, Olav L., primary, Klitgaard, Thomas L., additional, Perner, Anders, additional, Wetterslev, Jørn, additional, Lange, Theis, additional, Siegemund, Martin, additional, Bäcklund, Minna, additional, Keus, Frederik, additional, Laake, Jon H., additional, Morgan, Matthew, additional, Thormar, Katrin M., additional, Rosborg, Søren A., additional, Bisgaard, Jannie, additional, Erntgaard, Annette E.S., additional, Lynnerup, Anne-Sofie H., additional, Pedersen, Rasmus L., additional, Crescioli, Elena, additional, Gielstrup, Theis C., additional, Behzadi, Meike T., additional, Poulsen, Lone M., additional, Estrup, Stine, additional, Laigaard, Jens P., additional, Andersen, Cheme, additional, Mortensen, Camilla B., additional, Brand, Björn A., additional, White, Jonathan, additional, Jarnvig, Inge-Lise, additional, Møller, Morten H., additional, Quist, Lars, additional, Bestle, Morten H., additional, Schønemann-Lund, Martin, additional, Kamper, Maj K., additional, Hindborg, Mathias, additional, Hollinger, Alexa, additional, Gebhard, Caroline E., additional, Zellweger, Núria, additional, Meyhoff, Christian S., additional, Hjort, Mathias, additional, Bech, Laura K., additional, Grøfte, Thorbjørn, additional, Bundgaard, Helle, additional, Østergaard, Lars H.M., additional, Thyø, Maria A., additional, Hildebrandt, Thomas, additional, Uslu, Bülent, additional, Sølling, Christoffer G., additional, Møller-Nielsen, Nette, additional, Brøchner, Anne C., additional, Borup, Morten, additional, Okkonen, Marjatta, additional, Dieperink, Willem, additional, Pedersen, Ulf G., additional, Andreasen, Anne S., additional, Buus, Lone, additional, Aslam, Tayyba N., additional, Winding, Robert R., additional, Schefold, Joerg C., additional, Thorup, Stine B., additional, Iversen, Susanne A., additional, Engstrøm, Janus, additional, Kjær, Maj-Brit N., additional, and Rasmussen, Bodil S., additional

Published
2021
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11. Oxygenation targets in ICU patients with COVID‐19: A post hoc subgroup analysis of the HOT‐ICU trial.

Author

Rasmussen, Bodil S., Klitgaard, Thomas L., Perner, Anders, Brand, Björn A., Hildebrandt, Thomas, Siegemund, Martin, Hollinger, Alexa, Aagaard, Søren R., Bestle, Morten H., Marcussen, Klaus V., Brøchner, Anne C., Sølling, Christoffer G., Poulsen, Lone M., Laake, Jon H., Aslam, Tayyba N., Bäcklund, Minna, Okkonen, Marjatta, Morgan, Matthew, Sharman, Mike, and Lange, Theis

Subjects
COVID-19, OXYGEN in the blood, POSITIVE end-expiratory pressure, SUBGROUP analysis (Experimental design), OXYGEN therapy
Abstract

Background: Supplemental oxygen is the key intervention for severe and critical COVID‐19 patients. With the unstable supplies of oxygen in many countries, it is important to define the lowest safe dosage. Methods: In spring 2020, 110 COVID‐19 patients were enrolled as part of the Handling Oxygenation Targets in the ICU trial (HOT‐ICU). Patients were allocated within 12 h of ICU admission. Oxygen therapy was titrated to a partial pressure of arterial oxygen (PaO2) of 8 kPa (lower oxygenation group) or a PaO2 of 12 kPa (higher oxygenation group) during ICU stay up to 90 days. We report key outcomes at 90 days for the subgroup of COVID‐19 patients. Results: At 90 days, 22 of 54 patients (40.7%) in the lower oxygenation group and 23 of 55 patients (41.8%) in the higher oxygenation group had died (adjusted risk ratio: 0.87; 95% confidence interval, 0.58–1.32). The percentage of days alive without life support was significantly higher in the lower oxygenation group (p = 0.03). The numbers of severe ischemic events were low with no difference between the two groups. Proning and inhaled vasodilators were used more frequently, and the positive end‐expiratory pressure was higher in the higher oxygenation group. Tests for interactions with the results of the remaining HOT‐ICU population were insignificant. Conclusions: Targeting a PaO2 of 8 kPa may be beneficial in ICU patients with COVID‐19. These results come with uncertainty due to the low number of patients in this unplanned subgroup analysis, and insignificant tests for interaction with the main HOT‐ICU trial. Trial registration number: ClinicalTrials.gov number, NCT03174002. Date of registration: June 2, 2017. [ABSTRACT FROM AUTHOR]

Published
2022
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12. Pantoprazole in Patients at Risk for Gastrointestinal Bleeding in the ICU

Author

Krag, Mette, primary, Marker, Søren, additional, Perner, Anders, additional, Wetterslev, Jørn, additional, Wise, Matt P., additional, Schefold, Joerg C., additional, Keus, Frederik, additional, Guttormsen, Anne B., additional, Bendel, Stepani, additional, Borthwick, Mark, additional, Lange, Theis, additional, Rasmussen, Bodil S., additional, Siegemund, Martin, additional, Bundgaard, Helle, additional, Elkmann, Thomas, additional, Jensen, Jacob V., additional, Nielsen, Rune D., additional, Liboriussen, Lisbeth, additional, Bestle, Morten H., additional, Elkjær, Jeanie M., additional, Palmqvist, Dorte F., additional, Bäcklund, Minna, additional, Laake, Jon H., additional, Bådstøløkken, Per M., additional, Grönlund, Juha, additional, Breum, Olena, additional, Walli, Akil, additional, Winding, Robert, additional, Iversen, Susanne, additional, Jarnvig, Inge-Lise, additional, White, Jonathan O., additional, Brand, Björn, additional, Madsen, Martin B., additional, Quist, Lars, additional, Thornberg, Klaus J., additional, Møller, Anders, additional, Wiis, Jørgen, additional, Granholm, Anders, additional, Anthon, Carl T., additional, Meyhoff, Tine S., additional, Hjortrup, Peter B., additional, Aagaard, Søren R., additional, Andreasen, Jo B., additional, Sørensen, Christina A., additional, Haure, Pernille, additional, Hauge, Jacob, additional, Hollinger, Alexa, additional, Scheuzger, Jonas, additional, Tuchscherer, Daniel, additional, Vuilliomenet, Thierry, additional, Takala, Jukka, additional, Jakob, Stephan M., additional, Vang, Marianne L., additional, Pælestik, Kim B., additional, Andersen, Karen L.D., additional, van der Horst, Iwan C.C., additional, Dieperink, Willem, additional, Fjølner, Jesper, additional, Kjer, Cilia K.W., additional, Sølling, Christine, additional, Sølling, Christoffer G., additional, Karttunen, Johanna, additional, Morgan, Matt P.G., additional, Sjøbø, Brit, additional, Engstrøm, Janus, additional, Agerholm-Larsen, Birgit, additional, and Møller, Morten H., additional

Published
2018
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13. Lower or Higher Oxygenation Targets for Acute Hypoxemic Respiratory Failure

Author

Schjørring, Olav L, Klitgaard, Thomas L, Perner, Anders, Wetterslev, Jørn, Lange, Theis, Siegemund, Martin, Bäcklund, Minna, Keus, Frederik, Laake, Jon H, Morgan, Matthew, Thormar, Katrin M, Rosborg, Søren A, Bisgaard, Jannie, Erntgaard, Annette E S, Lynnerup, Anne-Sofie H, Pedersen, Rasmus L, Crescioli, Elena, Gielstrup, Theis C, Behzadi, Meike T, Poulsen, Lone M, Estrup, Stine, Laigaard, Jens P, Andersen, Cheme, Mortensen, Camilla B, Brand, Björn A, White, Jonathan, Jarnvig, Inge-Lise, Møller, Morten H, Quist, Lars, Bestle, Morten H, Schønemann-Lund, Martin, Kamper, Maj K, Hindborg, Mathias, Hollinger, Alexa, Gebhard, Caroline E, Zellweger, Núria, Meyhoff, Christian S, Hjort, Mathias, Bech, Laura K, Grøfte, Thorbjørn, Bundgaard, Helle, Østergaard, Lars H M, Thyø, Maria A, Hildebrandt, Thomas, Uslu, Bülent, Sølling, Christoffer G, Møller-Nielsen, Nette, Brøchner, Anne C, Borup, Morten, Okkonen, Marjatta, Dieperink, Willem, Pedersen, Ulf G, Andreasen, Anne S, Buus, Lone, Aslam, Tayyba N, Winding, Robert R, Schefold, Joerg C, Thorup, Stine B, Iversen, Susanne A, Engstrøm, Janus, Kjær, Maj-Brit N, and Rasmussen, Bodil S

Subjects
610 Medicine & health, 3. Good health
Abstract

BACKGROUND Patients with acute hypoxemic respiratory failure in the intensive care unit (ICU) are treated with supplemental oxygen, but the benefits and harms of different oxygenation targets are unclear. We hypothesized that using a lower target for partial pressure of arterial oxygen (Pao2) would result in lower mortality than using a higher target. METHODS In this multicenter trial, we randomly assigned 2928 adult patients who had recently been admitted to the ICU (≤12 hours before randomization) and who were receiving at least 10 liters of oxygen per minute in an open system or had a fraction of inspired oxygen of at least 0.50 in a closed system to receive oxygen therapy targeting a Pao2 of either 60 mm Hg (lower-oxygenation group) or 90 mm Hg (higher-oxygenation group) for a maximum of 90 days. The primary outcome was death within 90 days. RESULTS At 90 days, 618 of 1441 patients (42.9%) in the lower-oxygenation group and 613 of 1447 patients (42.4%) in the higher-oxygenation group had died (adjusted risk ratio, 1.02; 95% confidence interval, 0.94 to 1.11; P = 0.64). At 90 days, there was no significant between-group difference in the percentage of days that patients were alive without life support or in the percentage of days they were alive after hospital discharge. The percentages of patients who had new episodes of shock, myocardial ischemia, ischemic stroke, or intestinal ischemia were similar in the two groups (P = 0.24). CONCLUSIONS Among adult patients with acute hypoxemic respiratory failure in the ICU, a lower oxygenation target did not result in lower mortality than a higher target at 90 days. (Funded by the Innovation Fund Denmark and others; HOT-ICU ClinicalTrials.gov number, NCT03174002.).

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