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1. Gender differences in mortality and quality of life after septic shock: A post-hoc analysis of the ARISE study

Author

Luethi, N, Bailey, M, Higgins, A, Howe, B, Peake, S, Delaney, A, Bellomo, R, Bennett, V, Board, J, McCracken, P, McGloughlin, S, Nanjayya, V, Teo, A, Hill, E, O'Brien, PJE, Sawtell, F, Schimanski, K, Wilson, D, Bolch, S, Eastwood, G, Kerr, F, Peak, L, Young, H, Edington, J, Fletcher, J, Smith, J, Ghelani, D, Nand, K, Sara, T, Cross, A, Flemming, D, Grummisch, M, Purdue, A, Fulton, E, Grove, K, Harney, A, Milburn, K, Millar, R, Mitchell, I, Rodgers, H, Scanlon, S, Coles, T, Connor, H, Dennett, J, Van Berkel, A, Barrington-Onslow, S, Henderson, S, Mehrtens, J, Dryburgh, J, Tankel, A, Braitberg, G, O'Bree, B, Shepherd, K, Vij, S, Allsop, S, Haji, D, Haji, K, Vuat, J, Bone, A, Elderkin, T, Orford, N, Ragg, M, Kelly, S, Stewart, D, Woodward, N, Harjola, V-P, Pettila, MO, Sutinen, S, Wilkman, E, Fratzia, J, Halkhoree, J, Treloar, S, Ryan, K, Sandford, T, Walsham, J, Jenkins, C, Williamson, D, Burrows, J, Hawkins, D, Tang, C, Dimakis, A, Holdgate, A, Micallef, S, Parr, M, White, H, Morrison, L, Sosnowski, K, Ramadoss, R, Soar, N, Wood, J, Franks, M, Williams, A, Hogan, C, Song, R, Tilsley, A, Rainsford, D, Wells, R, Dowling, J, Galt, P, Lamac, T, Lightfoot, D, Walker, C, Braid, K, DeVillecourt, T, Tan, HS, Seppelt, I, Chang, LF, Cheung, WS, Fok, SK, Lam, PK, Lam, SM, So, HM, Yan, W, Altea, A, Lancashire, B, Gomersall, CD, Graham, CA, Leung, P, Arora, S, Bass, F, Shehabi, Y, Isoardi, J, Isoardi, K, Powrie, D, Lawrence, S, Ankor, A, Chester, L, Davies, M, O'Connor, S, Poole, A, Soulsby, T, Sundararajan, K, Williams, J, Greenslade, JH, MacIsaac, C, Gorman, K, Jordan, A, Moore, L, Ankers, S, Bird, S, Fogg, T, Hickson, E, Jewell, T, Kyneur, K, O'Connor, A, Townsend, J, Yarad, E, Brown, S, Chamberlain, J, Cooper, J, Jenkinson, E, McDonald, E, Webb, S, Buhr, H, Coakley, J, Cowell, J, Hutch, D, Gattas, D, Keir, M, Rajbhandari, D, Rees, C, Baker, S, Roberts, B, Farone, E, Holmes, J, Santamaria, J, Winter, C, Finckh, A, Knowles, S, McCabe, J, Nair, P, Reynolds, C, Ahmed, B, Barton, D, Meaney, E, Nichol, A, Harris, R, Shields, L, Thomas, K, Karlsson, S, Kuitunen, A, Kukkurainen, A, Tenhunen, J, Varila, S, Ryan, N, Trethewy, C, Crosdale, J, Smith, JC, Vellaichamy, M, Furyk, J, Gordon, G, Jones, L, Senthuran, S, Bates, S, Butler, J, French, C, Tippett, A, Kelly, J, Kwans, J, Murphy, M, O'Flynn, D, Kurenda, C, Otto, T, Raniga, V, Williams, P, Ho, HF, Leung, A, Wu, H, Luethi, N, Bailey, M, Higgins, A, Howe, B, Peake, S, Delaney, A, Bellomo, R, Bennett, V, Board, J, McCracken, P, McGloughlin, S, Nanjayya, V, Teo, A, Hill, E, O'Brien, PJE, Sawtell, F, Schimanski, K, Wilson, D, Bolch, S, Eastwood, G, Kerr, F, Peak, L, Young, H, Edington, J, Fletcher, J, Smith, J, Ghelani, D, Nand, K, Sara, T, Cross, A, Flemming, D, Grummisch, M, Purdue, A, Fulton, E, Grove, K, Harney, A, Milburn, K, Millar, R, Mitchell, I, Rodgers, H, Scanlon, S, Coles, T, Connor, H, Dennett, J, Van Berkel, A, Barrington-Onslow, S, Henderson, S, Mehrtens, J, Dryburgh, J, Tankel, A, Braitberg, G, O'Bree, B, Shepherd, K, Vij, S, Allsop, S, Haji, D, Haji, K, Vuat, J, Bone, A, Elderkin, T, Orford, N, Ragg, M, Kelly, S, Stewart, D, Woodward, N, Harjola, V-P, Pettila, MO, Sutinen, S, Wilkman, E, Fratzia, J, Halkhoree, J, Treloar, S, Ryan, K, Sandford, T, Walsham, J, Jenkins, C, Williamson, D, Burrows, J, Hawkins, D, Tang, C, Dimakis, A, Holdgate, A, Micallef, S, Parr, M, White, H, Morrison, L, Sosnowski, K, Ramadoss, R, Soar, N, Wood, J, Franks, M, Williams, A, Hogan, C, Song, R, Tilsley, A, Rainsford, D, Wells, R, Dowling, J, Galt, P, Lamac, T, Lightfoot, D, Walker, C, Braid, K, DeVillecourt, T, Tan, HS, Seppelt, I, Chang, LF, Cheung, WS, Fok, SK, Lam, PK, Lam, SM, So, HM, Yan, W, Altea, A, Lancashire, B, Gomersall, CD, Graham, CA, Leung, P, Arora, S, Bass, F, Shehabi, Y, Isoardi, J, Isoardi, K, Powrie, D, Lawrence, S, Ankor, A, Chester, L, Davies, M, O'Connor, S, Poole, A, Soulsby, T, Sundararajan, K, Williams, J, Greenslade, JH, MacIsaac, C, Gorman, K, Jordan, A, Moore, L, Ankers, S, Bird, S, Fogg, T, Hickson, E, Jewell, T, Kyneur, K, O'Connor, A, Townsend, J, Yarad, E, Brown, S, Chamberlain, J, Cooper, J, Jenkinson, E, McDonald, E, Webb, S, Buhr, H, Coakley, J, Cowell, J, Hutch, D, Gattas, D, Keir, M, Rajbhandari, D, Rees, C, Baker, S, Roberts, B, Farone, E, Holmes, J, Santamaria, J, Winter, C, Finckh, A, Knowles, S, McCabe, J, Nair, P, Reynolds, C, Ahmed, B, Barton, D, Meaney, E, Nichol, A, Harris, R, Shields, L, Thomas, K, Karlsson, S, Kuitunen, A, Kukkurainen, A, Tenhunen, J, Varila, S, Ryan, N, Trethewy, C, Crosdale, J, Smith, JC, Vellaichamy, M, Furyk, J, Gordon, G, Jones, L, Senthuran, S, Bates, S, Butler, J, French, C, Tippett, A, Kelly, J, Kwans, J, Murphy, M, O'Flynn, D, Kurenda, C, Otto, T, Raniga, V, Williams, P, Ho, HF, Leung, A, and Wu, H

Abstract

PURPOSE: To assess the impact of gender and pre-menopausal state on short- and long-term outcomes in patients with septic shock. MATERIAL AND METHODS: Cohort study of the Australasian Resuscitation in Sepsis Evaluation (ARISE) trial, an international randomized controlled trial comparing early goal-directed therapy (EGDT) to usual care in patients with early septic shock, conducted between October 2008 and April 2014. The primary exposure in this analysis was legal gender and the secondary exposure was pre-menopausal state defined by chronological age (≤ 50 years). RESULTS: 641 (40.3%) of all 1591 ARISE trial participants in the intention-to-treat population were females and overall, 337 (21.2%) (146 females) patients were 50 years of age or younger. After risk-adjustment, we could not identify any survival benefit for female patients at day 90 in the younger (≤50 years) (adjusted Odds Ratio (aOR): 0.91 (0.46-1.89), p = .85) nor in the older (>50 years) age-group (aOR: 1.10 (0.81-1.49), p = .56). Similarly, there was no gender-difference in ICU, hospital, 1-year mortality nor quality of life measures. CONCLUSIONS: This post-hoc analysis of a large multi-center trial in early septic shock has shown no short- or long-term survival effect for women overall as well as in the pre-menopausal age-group.

Published
2020

2. Can pre-hospital administration reduce time to initial antibiotic therapy in septic patients?.

Author

Lightfoot D., Santamaria J., Winter C., Bates S., Butler J., French C., Tippett A., Shepherd K., Vij S., Cudini D., Smith K., Bernard S., Stephenson M., Andrew E., Cameron P., Lum M., Udy A., Bennett V., Board J., McCracken P., McGloughlin S., Nanjayya V., Teo A., Bellomo R., Bolch S., Eastwood G., Kerr F., Peak L., Young H., Edington J., Fletcher J., Smith J., Cross A., Flemming D., Grummisch M., Purdue A., Coles T., Connor H., Dennett J., Van Berkel A., Braitberg G., O'Bree B., Allsop S., Haji D., Haji K., Vuat J., Bone A., Elderkin T., Orford N., Ragg M., Dowling J., Galt P., Lamac T., Walker C., MacIsaac C., Gorman K., Jordan A., Moore L., Farone E., Holmes J., Lightfoot D., Santamaria J., Winter C., Bates S., Butler J., French C., Tippett A., Shepherd K., Vij S., Cudini D., Smith K., Bernard S., Stephenson M., Andrew E., Cameron P., Lum M., Udy A., Bennett V., Board J., McCracken P., McGloughlin S., Nanjayya V., Teo A., Bellomo R., Bolch S., Eastwood G., Kerr F., Peak L., Young H., Edington J., Fletcher J., Smith J., Cross A., Flemming D., Grummisch M., Purdue A., Coles T., Connor H., Dennett J., Van Berkel A., Braitberg G., O'Bree B., Allsop S., Haji D., Haji K., Vuat J., Bone A., Elderkin T., Orford N., Ragg M., Dowling J., Galt P., Lamac T., Walker C., MacIsaac C., Gorman K., Jordan A., Moore L., Farone E., and Holmes J.

Abstract

Objective: To quantify the potential time saved with pre-hospital antibiotic therapy in sepsis. Method(s): Study data for adult patients transported by Ambulance Victoria (AV), and enrolled into the Australasian Resuscitation In Sepsis Evaluation (ARISE), were linked with pre-hospital electronic records. Result(s): An AV record was identified for 240 of 341 ARISE patients. The pre-hospital case notes referred to potential infection in 165 patients. The median time to first antibiotic administration from loading the patient into the ambulance was 107 (74-160) min. Conclusion(s): ARISE patients in Victoria were frequently identified pre-hospital. An opportunity exists to study the feasibility of pre-hospital antibiotic therapy.Copyright © 2019 Australasian College for Emergency Medicine

Published
2019

3. Can pre-hospital administration reduce time to initial antibiotic therapy in septic patients?.

Author

Lightfoot D., Santamaria J., Winter C., Bates S., Butler J., French C., Tippett A., Shepherd K., Vij S., Cudini D., Smith K., Bernard S., Stephenson M., Andrew E., Cameron P., Lum M., Udy A., Bennett V., Board J., McCracken P., McGloughlin S., Nanjayya V., Teo A., Bellomo R., Bolch S., Eastwood G., Kerr F., Peak L., Young H., Edington J., Fletcher J., Smith J., Cross A., Flemming D., Grummisch M., Purdue A., Coles T., Connor H., Dennett J., Van Berkel A., Braitberg G., O'Bree B., Allsop S., Haji D., Haji K., Vuat J., Bone A., Elderkin T., Orford N., Ragg M., Dowling J., Galt P., Lamac T., Walker C., MacIsaac C., Gorman K., Jordan A., Moore L., Farone E., Holmes J., Lightfoot D., Santamaria J., Winter C., Bates S., Butler J., French C., Tippett A., Shepherd K., Vij S., Cudini D., Smith K., Bernard S., Stephenson M., Andrew E., Cameron P., Lum M., Udy A., Bennett V., Board J., McCracken P., McGloughlin S., Nanjayya V., Teo A., Bellomo R., Bolch S., Eastwood G., Kerr F., Peak L., Young H., Edington J., Fletcher J., Smith J., Cross A., Flemming D., Grummisch M., Purdue A., Coles T., Connor H., Dennett J., Van Berkel A., Braitberg G., O'Bree B., Allsop S., Haji D., Haji K., Vuat J., Bone A., Elderkin T., Orford N., Ragg M., Dowling J., Galt P., Lamac T., Walker C., MacIsaac C., Gorman K., Jordan A., Moore L., Farone E., and Holmes J.

Abstract

Objective: To quantify the potential time saved with pre-hospital antibiotic therapy in sepsis. Method(s): Study data for adult patients transported by Ambulance Victoria (AV), and enrolled into the Australasian Resuscitation In Sepsis Evaluation (ARISE), were linked with pre-hospital electronic records. Result(s): An AV record was identified for 240 of 341 ARISE patients. The pre-hospital case notes referred to potential infection in 165 patients. The median time to first antibiotic administration from loading the patient into the ambulance was 107 (74-160) min. Conclusion(s): ARISE patients in Victoria were frequently identified pre-hospital. An opportunity exists to study the feasibility of pre-hospital antibiotic therapy.Copyright © 2019 Australasian College for Emergency Medicine

Published
2019

4. Day or overnight transfusion in critically ill patients: does it matter?

Author

Aubron, C., Kandane-Rathnayake, R., Andrianopoulos, N., Westbrook, A., Engelbrecht, S., Ozolins, I., Bailey, M., Murray, L., Cooper, D., Wood, E., McQuilten, Z., Pettilä, V., Nichol, A., Syres, G., Phillips, L., Street, A., French, C., Orford, N., Santamaria, J., Bellomo, R., Vallance, S., McArthur, C., McGuiness, S., Newby, L., Simmonds, C., Parke, R., Buhr, H., Goldsmith, D., O'Sullivan, K., Mercer, I., Gazzard, R., Tauschke, C., Hill, D., Fletcher, J., Boschert, C., Koch, G., Ernest, D., Eliott, S., Howe, B., Hawker, F., Ellem, K., Duff, K., Henderson, S., Mehrtens, J., Milliss, D., Wong, H., Arora, S., O'Bree, B., Shepherd, K., Ihle, B., Ho, S., Graan, M., Bernsten, A., Ryan, E., Botha, J., Vuat, J., Kinmonth, A., Fraser, M., Richards, B., Tallott, M., Whitbread, R., Freebairn, R., Thomas, L., Parr, M., Micallef, S., Deshpande, K., Wood, J., Williams, Teresa, Tai, J., Boase, A., Galt, P., King, B., Price, R., Tomlinson, J., Cole, L., Seppelt, I., Weisbrodt, L., Gresham, R., Nikas, M., Laing, J., Bell, J., McHugh, G., Hancock, D., Kirkham, S., Shehabi, Y., Campbell, M., Aubron, C., Kandane-Rathnayake, R., Andrianopoulos, N., Westbrook, A., Engelbrecht, S., Ozolins, I., Bailey, M., Murray, L., Cooper, D., Wood, E., McQuilten, Z., Pettilä, V., Nichol, A., Syres, G., Phillips, L., Street, A., French, C., Orford, N., Santamaria, J., Bellomo, R., Vallance, S., McArthur, C., McGuiness, S., Newby, L., Simmonds, C., Parke, R., Buhr, H., Goldsmith, D., O'Sullivan, K., Mercer, I., Gazzard, R., Tauschke, C., Hill, D., Fletcher, J., Boschert, C., Koch, G., Ernest, D., Eliott, S., Howe, B., Hawker, F., Ellem, K., Duff, K., Henderson, S., Mehrtens, J., Milliss, D., Wong, H., Arora, S., O'Bree, B., Shepherd, K., Ihle, B., Ho, S., Graan, M., Bernsten, A., Ryan, E., Botha, J., Vuat, J., Kinmonth, A., Fraser, M., Richards, B., Tallott, M., Whitbread, R., Freebairn, R., Thomas, L., Parr, M., Micallef, S., Deshpande, K., Wood, J., Williams, Teresa, Tai, J., Boase, A., Galt, P., King, B., Price, R., Tomlinson, J., Cole, L., Seppelt, I., Weisbrodt, L., Gresham, R., Nikas, M., Laing, J., Bell, J., McHugh, G., Hancock, D., Kirkham, S., Shehabi, Y., and Campbell, M.

Abstract

Background and objectives: The timing of blood administration in critically ill patients is first driven by patients' needs. This study aimed to define the epidemiology and significance of overnight transfusion in critically ill patients. Materials and methods: This is a post hoc analysis of a prospective multicentre observational study including 874 critically ill patients receiving red blood cells, platelets, fresh frozen plasma (FFP) or cryoprecipitate. Characteristics of patients receiving blood only during the day (8 am up until 8 pm) were compared to those receiving blood only overnight (8 pm up until 8 am). Characteristics of transfusion were compared, and factors independently associated with major bleeding were analysed. Results: The 287 patients transfused during the day only had similar severity and mortality to the 258 receiving blood products overnight only. Although bleeding-related admission diagnoses were similar, major bleeding was the indication for transfusion in 12% of patients transfused in daytime only versus 30% of patients transfused at night only (P < 0·001). Similar total amount of blood products were transfused at day and night (2856 versus 2927); however, patients were more likely to receive FFP and cryoprecipitate at night compared with daytime. Overnight transfusion was independently associated with increased odds of major bleeding (odds ratio, 3·16, 95% confidence interval, 2·00–5·01). Conclusion: Transfusion occurs evenly across day and night in ICU; nonetheless, there are differences in type of blood products administered that reflect differences in indication. Critically ill patients were more likely to receive blood for major bleeding at night irrespective of admission diagnosis.

Published
2018

5. Heparin-induced thrombocytopenia in the critically ill: Interpreting the 4Ts test in a randomized trial.

Author

Hebert P., Murphy E., Foxall J., Skrobik Y., Harvey J., Chitu S., Sirois C., Nadon C., Dolle S., Barge D., Caf T., Howe B., Bellomo R., Eastwood G., Peck L., Goldsmith D., O'Sullivan K., Ernest D., Radford S., Whitfield A., Cross A., Eliott S., Sidhu J., Mercer I., Hamilton A., Botha J., Vuat J., Allsop S., Fowler N., Crozier T., Barrett J., Wright C., Galt P., Culhane C., Ioannidis R., Burton S., Reily M., Weeraratna C., Seppelt I., Weisbrodt L., Bond R., Evans D., Rivett J., O'Connor S., Poole A., Woolfe C., Rajbhandari D., Rees C., Edington J., Fletcher J., Smith J., Boschert C., Reece G., Sara T., Nand K., Bersten A., Gallus A., Matheson E., O'Callaghan M., Orford N., Elderkin T., Fraser M., Bone A., Salerno T., Kinmonth A., Arora S., O'Bree B., Shepherd K., Davey-Quinn A., Sterba M., Johnson B.R., Xu R., Hill F., Ramadoss R., Wood J., Crowther M., Cook D., Guyatt G., Zytaruk N., McDonald E., Williamson D., Albert M., Dodek P., Finfer S., Vallance S., Heels-Ansdell D., McIntyre L., Mehta S., Lamontagne F., Muscedere J., Jacka M., Lesur O., Kutsiogiannis J., Friedrich J., Klinger J.R., Qushmaq I., Burry L., Khwaja K., Sheppard J.-A., Warkentin T.E., Tkaczyk A., Clarke F., Hall R., Rocker G., Julien L., Wright D., Roy C., Theriault J., Pleasance S., Meade M., Hand L., Freitag A., Wynne C., Duffett M., Kho M., Granton J., Matte A., Farias P., Chu L., Brockest N., Go S., McGrath-Chong M., Dennis M., Lipkus M., Stern E., Albert R., Langevin S., Lauzier F., Turgeon A.F., Blais M., Beauparlant M., Asselin J., Gagne C., Thibodeau M., Poirier G., Neas I., Spearson S., Watpool I., McArdle T., Gaudert C., Marchand P., Davidson C., Pagliarello J., Lewis M.-J., Gosselin A.-A., Deroy P., Ethier C., Tirgari S., Steinberg L., McDonald R., Sivanantham V., Bandayrel K., Quittnat-Pelletier F., Kramer-Kile M., Brown M., Kim S., Fowler R., Marinoff N., Code K., Bojilov B., Parsotam D., Marshall J., Smith O., Fry B., Porretta K., Lee Y., Morrissey J., Wen V., Fleury S., Godfrey N., Hammond S., Mann E., Myers M., Robinson A., Keenan S., Reynolds S., Svetik M., Osch M.V., Chittock D., Dhingra V., Gardner M., Logie S., Foster D., Autio R., Davies D., Ganz P., Smith L., Ashley B.J., Mans S., Doig C., Knox L., Wilson C., Champagne K., Ferguson N., Stevenson J., Elman J., Kutsogiannis J., Thompson P., Whalen N., Lellouche F., Ferland M.-C., Dussault P., Jacob C., Morneau M.-E., Laberge N., Karachi T., Irwin M., Chan C., Sonnema L., Marsh K., Maurer J., Kreidl T., Varden C., Kinjerski C., Banici L., Havell L., Wood G., Auld F., Atkins L., Proulx S., Hollinger G., Shende V., Belcastro V., Plaxton B., Foss A., Paunovic B., Wiebe K., Marten N., Eisenstat J., Doerle T., Sharpe M., Madady M., Cooper J., Davies A., Weatherburn C., Board J., Bennett V., Ramakrishnan N., Bird S., Potter J., O'Connor A., Ankers S., Cade J., Hebert P., Murphy E., Foxall J., Skrobik Y., Harvey J., Chitu S., Sirois C., Nadon C., Dolle S., Barge D., Caf T., Howe B., Bellomo R., Eastwood G., Peck L., Goldsmith D., O'Sullivan K., Ernest D., Radford S., Whitfield A., Cross A., Eliott S., Sidhu J., Mercer I., Hamilton A., Botha J., Vuat J., Allsop S., Fowler N., Crozier T., Barrett J., Wright C., Galt P., Culhane C., Ioannidis R., Burton S., Reily M., Weeraratna C., Seppelt I., Weisbrodt L., Bond R., Evans D., Rivett J., O'Connor S., Poole A., Woolfe C., Rajbhandari D., Rees C., Edington J., Fletcher J., Smith J., Boschert C., Reece G., Sara T., Nand K., Bersten A., Gallus A., Matheson E., O'Callaghan M., Orford N., Elderkin T., Fraser M., Bone A., Salerno T., Kinmonth A., Arora S., O'Bree B., Shepherd K., Davey-Quinn A., Sterba M., Johnson B.R., Xu R., Hill F., Ramadoss R., Wood J., Crowther M., Cook D., Guyatt G., Zytaruk N., McDonald E., Williamson D., Albert M., Dodek P., Finfer S., Vallance S., Heels-Ansdell D., McIntyre L., Mehta S., Lamontagne F., Muscedere J., Jacka M., Lesur O., Kutsiogiannis J., Friedrich J., Klinger J.R., Qushmaq I., Burry L., Khwaja K., Sheppard J.-A., Warkentin T.E., Tkaczyk A., Clarke F., Hall R., Rocker G., Julien L., Wright D., Roy C., Theriault J., Pleasance S., Meade M., Hand L., Freitag A., Wynne C., Duffett M., Kho M., Granton J., Matte A., Farias P., Chu L., Brockest N., Go S., McGrath-Chong M., Dennis M., Lipkus M., Stern E., Albert R., Langevin S., Lauzier F., Turgeon A.F., Blais M., Beauparlant M., Asselin J., Gagne C., Thibodeau M., Poirier G., Neas I., Spearson S., Watpool I., McArdle T., Gaudert C., Marchand P., Davidson C., Pagliarello J., Lewis M.-J., Gosselin A.-A., Deroy P., Ethier C., Tirgari S., Steinberg L., McDonald R., Sivanantham V., Bandayrel K., Quittnat-Pelletier F., Kramer-Kile M., Brown M., Kim S., Fowler R., Marinoff N., Code K., Bojilov B., Parsotam D., Marshall J., Smith O., Fry B., Porretta K., Lee Y., Morrissey J., Wen V., Fleury S., Godfrey N., Hammond S., Mann E., Myers M., Robinson A., Keenan S., Reynolds S., Svetik M., Osch M.V., Chittock D., Dhingra V., Gardner M., Logie S., Foster D., Autio R., Davies D., Ganz P., Smith L., Ashley B.J., Mans S., Doig C., Knox L., Wilson C., Champagne K., Ferguson N., Stevenson J., Elman J., Kutsogiannis J., Thompson P., Whalen N., Lellouche F., Ferland M.-C., Dussault P., Jacob C., Morneau M.-E., Laberge N., Karachi T., Irwin M., Chan C., Sonnema L., Marsh K., Maurer J., Kreidl T., Varden C., Kinjerski C., Banici L., Havell L., Wood G., Auld F., Atkins L., Proulx S., Hollinger G., Shende V., Belcastro V., Plaxton B., Foss A., Paunovic B., Wiebe K., Marten N., Eisenstat J., Doerle T., Sharpe M., Madady M., Cooper J., Davies A., Weatherburn C., Board J., Bennett V., Ramakrishnan N., Bird S., Potter J., O'Connor A., Ankers S., and Cade J.

Abstract

Background: Thrombocytopenia occurs in 20% to 45% of critically ill medical-surgical patients. The 4Ts heparin-induced thrombocytopenia (HIT) score (with 4 domains: Thrombocytopenia, Timing of thrombocytopenia, Thrombosis and o. Ther reason[s] for thrombocytopenia) might reliably identify patients at low risk for HIT. Interobserver agreement on 4Ts scoring is uncertain in this setting. Objective(s): To evaluate whether a published clinical prediction rule (the "4Ts score") reliably rules out HIT in "low-risk" intensive care unit (ICU) patients as assessed by research coordinators (who prospectively scored) and 2 adjudicators (who scored retrospectively) during an international heparin thromboprophylaxis trial (PROTECT, NCT00182143). Method(s): Of 3746 medical-surgical ICU patients in PROTECT, 794 met the enrollment criteria for this HIT substudy. Enrollment was predicated on one of the following occurring in ICU: platelets less than 50 x 109/L, platelets decreased to 50% of ICU admission value (if admission value <100 x 109/L), any venous thrombosis, or if HIT was otherwise clinically suspected. Independently, 4Ts scores were completed in real time by research coordinators blinded to study drug and laboratory HIT results, and retrospectively by 2 adjudicators blinded to study drug, laboratory HIT results, and research coordinators' scores; the adjudicators arrived at consensus in all cases. Of the 763 patients, 474 had a central or local laboratory HIT test performed and had 4Ts scoring by adjudicators; 432 were scored by trained research coordinators. Heparin-induced thrombocytopenia was defined by a centrally performed positive serotonin release assay (SRA). Result(s): Of the 474 patients with central adjudication, 407 (85.9%) had a 4Ts score of 3 or lower, conferring a low pretest probability (PTP) of HIT; of these, 6 (1.5% [95% confidence interval, 0.7%-3.2%) had a positive SRA. Fifty-nine (12.4%) had a moderate PTP (4Ts score of 4-5); of these, 4 (6.8%) had a p

Published
2014

6. Long-Term Survival and Dialysis Dependency Following Acute Kidney Injury in Intensive Care: Extended Follow-up of a Randomized Controlled Trial.

Author

Bird S., Caf T., Weisbrodt L., Whereat S., Shehabi Y., Bass F., Edhouse P., Jenkins M., Jordon A., O'Connor A., Totaro R., Honeysett L., Inskip D., Sidoli R., Nair P., Reynolds C., Banerjee A., Kong J., Skelly C., Brown J., Gilder E., McArthur C., Newby L., Simmonds C., Henderson S., Mehrtens J., Sugden D., Kalkoff M., McGregor K., Shaw C., Morgan J., Gregory K., Sutton J., Garrett P., Buckley A., McDonald S., Joyce C., Harward M., Sexton G., Perkins K., Starr T., Flabouris A., O'Connor S., Rivett J., Turner A., McAllister R., Trubody V., Eastwood G., Peck L., Fletcher J., Ihle B., Ho S., Micallef J., Murray L., Botha J., Allsop S., Vuat J., Cattigan C., Elderkin T., Walker C., Galt P., Gillies A., Harley N., Barge D., Santamaria J., Holmes J., Smith R., Scheinkestel C., Donaldson H., Vallance S., French C., Bates S., Butler J., Breheny F., Palermo A., Dobb G., Chamberlain J., Lord P., Jun M., Yianni A., D'Haeseleer S., Lipman J., Dunlop R., Lassig-Smith M., Gallagher M., Cass A., Bellomo R., Finfer S., Gattas D., Lee J., Lo S., McGuinness S., Myburgh J., Parke R., Rajbhandari D., Mitchell I., Taylor E., Whyte R., Raza A., Nand K., Sara T., Millis D., Wong H., Harrigan P., Hardie M., Whitaker D., Bhonagiri D., Micallef S., Ellem K., Lintott M., Cole L., Cuzner C., Bird S., Caf T., Weisbrodt L., Whereat S., Shehabi Y., Bass F., Edhouse P., Jenkins M., Jordon A., O'Connor A., Totaro R., Honeysett L., Inskip D., Sidoli R., Nair P., Reynolds C., Banerjee A., Kong J., Skelly C., Brown J., Gilder E., McArthur C., Newby L., Simmonds C., Henderson S., Mehrtens J., Sugden D., Kalkoff M., McGregor K., Shaw C., Morgan J., Gregory K., Sutton J., Garrett P., Buckley A., McDonald S., Joyce C., Harward M., Sexton G., Perkins K., Starr T., Flabouris A., O'Connor S., Rivett J., Turner A., McAllister R., Trubody V., Eastwood G., Peck L., Fletcher J., Ihle B., Ho S., Micallef J., Murray L., Botha J., Allsop S., Vuat J., Cattigan C., Elderkin T., Walker C., Galt P., Gillies A., Harley N., Barge D., Santamaria J., Holmes J., Smith R., Scheinkestel C., Donaldson H., Vallance S., French C., Bates S., Butler J., Breheny F., Palermo A., Dobb G., Chamberlain J., Lord P., Jun M., Yianni A., D'Haeseleer S., Lipman J., Dunlop R., Lassig-Smith M., Gallagher M., Cass A., Bellomo R., Finfer S., Gattas D., Lee J., Lo S., McGuinness S., Myburgh J., Parke R., Rajbhandari D., Mitchell I., Taylor E., Whyte R., Raza A., Nand K., Sara T., Millis D., Wong H., Harrigan P., Hardie M., Whitaker D., Bhonagiri D., Micallef S., Ellem K., Lintott M., Cole L., and Cuzner C.

Abstract

Background:The incidence of acute kidney injury (AKI) is increasing globally and it is much more common than end-stage kidney disease. AKI is associated with high mortality and cost of hospitalisation. Studies of treatments to reduce this high mortality have used differing renal replacement therapy (RRT) modalities and have not shown improvement in the short term. The reported long-term outcomes of AKI are variable and the effect of differing RRT modalities upon them is not clear. We used the prolonged follow-up of a large clinical trial to prospectively examine the long-term outcomes and effect of RRT dosing in patients with AKI.Methods and Findings:We extended the follow-up of participants in the Randomised Evaluation of Normal vs. Augmented Levels of RRT (RENAL) study from 90 days to 4 years after randomization. Primary and secondary outcomes were mortality and requirement for maintenance dialysis, respectively, assessed in 1,464 (97%) patients at a median of 43.9 months (interquartile range [IQR] 30.0-48.6 months) post randomization. A total of 468/743 (63%) and 444/721 (62%) patients died in the lower and higher intensity groups, respectively (risk ratio [RR] 1.04, 95% CI 0.96-1.12, p = 0.49). Amongst survivors to day 90, 21 of 411 (5.1%) and 23 of 399 (5.8%) in the respective groups were treated with maintenance dialysis (RR 1.12, 95% CI 0.63-2.00, p = 0.69). The prevalence of albuminuria among survivors was 40% and 44%, respectively (p = 0.48). Quality of life was not different between the two treatment groups. The generalizability of these findings to other populations with AKI requires further exploration. Conclusion(s):Patients with AKI requiring RRT in intensive care have high long-term mortality but few require maintenance dialysis. Long-term survivors have a heavy burden of proteinuria. Increased intensity of RRT does not reduce mortality or subsequent treatment with dialysis.Trial registration:http://www.ClinicalTrials.gov NCT00221013 Please see later

Published
2014

7. Long-Term Survival and Dialysis Dependency Following Acute Kidney Injury in Intensive Care: Extended Follow-up of a Randomized Controlled Trial

Author

Gallagher, M, Cass, A, Bellomo, R, Finfer, S, Gattas, D, Lee, J, Lo, S, McGuinness, S, Myburgh, J, Parke, R, Rajbhandari, D, Mitchell, I, Taylor, E, Whyte, R, Raza, A, Nand, K, Sara, T, Millis, D, Wong, H, Harrigan, P, Hardie, M, Whitaker, D, Bhonagiri, D, Micallef, S, Ellem, K, Lintott, M, Cole, L, Cuzner, C, Weisbrodt, L, Whereat, S, Shehabi, Y, Bass, F, Edhouse, P, Jenkins, M, Bird, S, O'Connor, A, Totaro, R, Honeysett, L, Inskip, D, Sidoli, R, Nair, P, Reynolds, C, Banerjee, A, Kong, J, Skelly, C, Brown, J, Gilder, E, McArthur, C, Newby, L, Simmonds, C, Henderson, S, Mehrtens, J, Sugden, D, Kalkoff, M, McGregor, K, Shaw, C, Morgan, J, Gregory, K, Sutton, J, Garrett, P, Buckley, A, McDonald, S, Joyce, C, Harward, M, Sexton, G, Perkins, K, Lipman, J, Dunlop, R, Lassig-Smith, M, Starr, T, Flabouris, A, O'Connor, S, Rivett, J, Turner, A, McAllister, R, Trubody, V, Eastwood, G, Peck, L, Fletcher, J, Ihle, B, Ho, S, Micallef, J, Murray, L, Botha, J, Allsop, S, Vuat, J, Cattigan, C, Elderkin, T, Walker, C, Galt, P, Gillies, A, Harley, N, Barge, D, Caf, T, Jordon, A, Santamaria, J, Holmes, J, Smith, R, Scheinkestel, C, Donaldson, H, Gallagher, M, Cass, A, Bellomo, R, Finfer, S, Gattas, D, Lee, J, Lo, S, McGuinness, S, Myburgh, J, Parke, R, Rajbhandari, D, Mitchell, I, Taylor, E, Whyte, R, Raza, A, Nand, K, Sara, T, Millis, D, Wong, H, Harrigan, P, Hardie, M, Whitaker, D, Bhonagiri, D, Micallef, S, Ellem, K, Lintott, M, Cole, L, Cuzner, C, Weisbrodt, L, Whereat, S, Shehabi, Y, Bass, F, Edhouse, P, Jenkins, M, Bird, S, O'Connor, A, Totaro, R, Honeysett, L, Inskip, D, Sidoli, R, Nair, P, Reynolds, C, Banerjee, A, Kong, J, Skelly, C, Brown, J, Gilder, E, McArthur, C, Newby, L, Simmonds, C, Henderson, S, Mehrtens, J, Sugden, D, Kalkoff, M, McGregor, K, Shaw, C, Morgan, J, Gregory, K, Sutton, J, Garrett, P, Buckley, A, McDonald, S, Joyce, C, Harward, M, Sexton, G, Perkins, K, Lipman, J, Dunlop, R, Lassig-Smith, M, Starr, T, Flabouris, A, O'Connor, S, Rivett, J, Turner, A, McAllister, R, Trubody, V, Eastwood, G, Peck, L, Fletcher, J, Ihle, B, Ho, S, Micallef, J, Murray, L, Botha, J, Allsop, S, Vuat, J, Cattigan, C, Elderkin, T, Walker, C, Galt, P, Gillies, A, Harley, N, Barge, D, Caf, T, Jordon, A, Santamaria, J, Holmes, J, Smith, R, Scheinkestel, C, and Donaldson, H

Abstract

Background:The incidence of acute kidney injury (AKI) is increasing globally and it is much more common than end-stage kidney disease. AKI is associated with high mortality and cost of hospitalisation. Studies of treatments to reduce this high mortality have used differing renal replacement therapy (RRT) modalities and have not shown improvement in the short term. The reported long-term outcomes of AKI are variable and the effect of differing RRT modalities upon them is not clear. We used the prolonged follow-up of a large clinical trial to prospectively examine the long-term outcomes and effect of RRT dosing in patients with AKI.Methods and Findings:We extended the follow-up of participants in the Randomised Evaluation of Normal vs. Augmented Levels of RRT (RENAL) study from 90 days to 4 years after randomization. Primary and secondary outcomes were mortality and requirement for maintenance dialysis, respectively, assessed in 1,464 (97%) patients at a median of 43.9 months (interquartile range [IQR] 30.0-48.6 months) post randomization. A total of 468/743 (63%) and 444/721 (62%) patients died in the lower and higher intensity groups, respectively (risk ratio [RR] 1.04, 95% CI 0.96-1.12, p = 0.49). Amongst survivors to day 90, 21 of 411 (5.1%) and 23 of 399 (5.8%) in the respective groups were treated with maintenance dialysis (RR 1.12, 95% CI 0.63-2.00, p = 0.69). The prevalence of albuminuria among survivors was 40% and 44%, respectively (p = 0.48). Quality of life was not different between the two treatment groups. The generalizability of these findings to other populations with AKI requires further exploration.Conclusions:Patients with AKI requiring RRT in intensive care have high long-term mortality but few require maintenance dialysis. Long-term survivors have a heavy burden of proteinuria. Increased intensity of RRT does not reduce mortality or subsequent treatment with dialysis.Trial registration:http://www.ClinicalTrials.gov NCT00221013 Please see later in

Published
2014

8. Heparin-induced thrombocytopenia in the critically ill: Interpreting the 4Ts test in a randomized trial.

Author

Hebert P., Murphy E., Foxall J., Skrobik Y., Harvey J., Chitu S., Sirois C., Nadon C., Dolle S., Barge D., Caf T., Howe B., Bellomo R., Eastwood G., Peck L., Goldsmith D., O'Sullivan K., Ernest D., Radford S., Whitfield A., Cross A., Eliott S., Sidhu J., Mercer I., Hamilton A., Botha J., Vuat J., Allsop S., Fowler N., Crozier T., Barrett J., Wright C., Galt P., Culhane C., Ioannidis R., Burton S., Reily M., Weeraratna C., Seppelt I., Weisbrodt L., Bond R., Evans D., Rivett J., O'Connor S., Poole A., Woolfe C., Rajbhandari D., Rees C., Edington J., Fletcher J., Smith J., Boschert C., Reece G., Sara T., Nand K., Bersten A., Gallus A., Matheson E., O'Callaghan M., Orford N., Elderkin T., Fraser M., Bone A., Salerno T., Kinmonth A., Arora S., O'Bree B., Shepherd K., Davey-Quinn A., Sterba M., Johnson B.R., Xu R., Hill F., Ramadoss R., Wood J., Crowther M., Cook D., Guyatt G., Zytaruk N., McDonald E., Williamson D., Albert M., Dodek P., Finfer S., Vallance S., Heels-Ansdell D., McIntyre L., Mehta S., Lamontagne F., Muscedere J., Jacka M., Lesur O., Kutsiogiannis J., Friedrich J., Klinger J.R., Qushmaq I., Burry L., Khwaja K., Sheppard J.-A., Warkentin T.E., Tkaczyk A., Clarke F., Hall R., Rocker G., Julien L., Wright D., Roy C., Theriault J., Pleasance S., Meade M., Hand L., Freitag A., Wynne C., Duffett M., Kho M., Granton J., Matte A., Farias P., Chu L., Brockest N., Go S., McGrath-Chong M., Dennis M., Lipkus M., Stern E., Albert R., Langevin S., Lauzier F., Turgeon A.F., Blais M., Beauparlant M., Asselin J., Gagne C., Thibodeau M., Poirier G., Neas I., Spearson S., Watpool I., McArdle T., Gaudert C., Marchand P., Davidson C., Pagliarello J., Lewis M.-J., Gosselin A.-A., Deroy P., Ethier C., Tirgari S., Steinberg L., McDonald R., Sivanantham V., Bandayrel K., Quittnat-Pelletier F., Kramer-Kile M., Brown M., Kim S., Fowler R., Marinoff N., Code K., Bojilov B., Parsotam D., Marshall J., Smith O., Fry B., Porretta K., Lee Y., Morrissey J., Wen V., Fleury S., Godfrey N., Hammond S., Mann E., Myers M., Robinson A., Keenan S., Reynolds S., Svetik M., Osch M.V., Chittock D., Dhingra V., Gardner M., Logie S., Foster D., Autio R., Davies D., Ganz P., Smith L., Ashley B.J., Mans S., Doig C., Knox L., Wilson C., Champagne K., Ferguson N., Stevenson J., Elman J., Kutsogiannis J., Thompson P., Whalen N., Lellouche F., Ferland M.-C., Dussault P., Jacob C., Morneau M.-E., Laberge N., Karachi T., Irwin M., Chan C., Sonnema L., Marsh K., Maurer J., Kreidl T., Varden C., Kinjerski C., Banici L., Havell L., Wood G., Auld F., Atkins L., Proulx S., Hollinger G., Shende V., Belcastro V., Plaxton B., Foss A., Paunovic B., Wiebe K., Marten N., Eisenstat J., Doerle T., Sharpe M., Madady M., Cooper J., Davies A., Weatherburn C., Board J., Bennett V., Ramakrishnan N., Bird S., Potter J., O'Connor A., Ankers S., Cade J., Hebert P., Murphy E., Foxall J., Skrobik Y., Harvey J., Chitu S., Sirois C., Nadon C., Dolle S., Barge D., Caf T., Howe B., Bellomo R., Eastwood G., Peck L., Goldsmith D., O'Sullivan K., Ernest D., Radford S., Whitfield A., Cross A., Eliott S., Sidhu J., Mercer I., Hamilton A., Botha J., Vuat J., Allsop S., Fowler N., Crozier T., Barrett J., Wright C., Galt P., Culhane C., Ioannidis R., Burton S., Reily M., Weeraratna C., Seppelt I., Weisbrodt L., Bond R., Evans D., Rivett J., O'Connor S., Poole A., Woolfe C., Rajbhandari D., Rees C., Edington J., Fletcher J., Smith J., Boschert C., Reece G., Sara T., Nand K., Bersten A., Gallus A., Matheson E., O'Callaghan M., Orford N., Elderkin T., Fraser M., Bone A., Salerno T., Kinmonth A., Arora S., O'Bree B., Shepherd K., Davey-Quinn A., Sterba M., Johnson B.R., Xu R., Hill F., Ramadoss R., Wood J., Crowther M., Cook D., Guyatt G., Zytaruk N., McDonald E., Williamson D., Albert M., Dodek P., Finfer S., Vallance S., Heels-Ansdell D., McIntyre L., Mehta S., Lamontagne F., Muscedere J., Jacka M., Lesur O., Kutsiogiannis J., Friedrich J., Klinger J.R., Qushmaq I., Burry L., Khwaja K., Sheppard J.-A., Warkentin T.E., Tkaczyk A., Clarke F., Hall R., Rocker G., Julien L., Wright D., Roy C., Theriault J., Pleasance S., Meade M., Hand L., Freitag A., Wynne C., Duffett M., Kho M., Granton J., Matte A., Farias P., Chu L., Brockest N., Go S., McGrath-Chong M., Dennis M., Lipkus M., Stern E., Albert R., Langevin S., Lauzier F., Turgeon A.F., Blais M., Beauparlant M., Asselin J., Gagne C., Thibodeau M., Poirier G., Neas I., Spearson S., Watpool I., McArdle T., Gaudert C., Marchand P., Davidson C., Pagliarello J., Lewis M.-J., Gosselin A.-A., Deroy P., Ethier C., Tirgari S., Steinberg L., McDonald R., Sivanantham V., Bandayrel K., Quittnat-Pelletier F., Kramer-Kile M., Brown M., Kim S., Fowler R., Marinoff N., Code K., Bojilov B., Parsotam D., Marshall J., Smith O., Fry B., Porretta K., Lee Y., Morrissey J., Wen V., Fleury S., Godfrey N., Hammond S., Mann E., Myers M., Robinson A., Keenan S., Reynolds S., Svetik M., Osch M.V., Chittock D., Dhingra V., Gardner M., Logie S., Foster D., Autio R., Davies D., Ganz P., Smith L., Ashley B.J., Mans S., Doig C., Knox L., Wilson C., Champagne K., Ferguson N., Stevenson J., Elman J., Kutsogiannis J., Thompson P., Whalen N., Lellouche F., Ferland M.-C., Dussault P., Jacob C., Morneau M.-E., Laberge N., Karachi T., Irwin M., Chan C., Sonnema L., Marsh K., Maurer J., Kreidl T., Varden C., Kinjerski C., Banici L., Havell L., Wood G., Auld F., Atkins L., Proulx S., Hollinger G., Shende V., Belcastro V., Plaxton B., Foss A., Paunovic B., Wiebe K., Marten N., Eisenstat J., Doerle T., Sharpe M., Madady M., Cooper J., Davies A., Weatherburn C., Board J., Bennett V., Ramakrishnan N., Bird S., Potter J., O'Connor A., Ankers S., and Cade J.

Abstract

Background: Thrombocytopenia occurs in 20% to 45% of critically ill medical-surgical patients. The 4Ts heparin-induced thrombocytopenia (HIT) score (with 4 domains: Thrombocytopenia, Timing of thrombocytopenia, Thrombosis and o. Ther reason[s] for thrombocytopenia) might reliably identify patients at low risk for HIT. Interobserver agreement on 4Ts scoring is uncertain in this setting. Objective(s): To evaluate whether a published clinical prediction rule (the "4Ts score") reliably rules out HIT in "low-risk" intensive care unit (ICU) patients as assessed by research coordinators (who prospectively scored) and 2 adjudicators (who scored retrospectively) during an international heparin thromboprophylaxis trial (PROTECT, NCT00182143). Method(s): Of 3746 medical-surgical ICU patients in PROTECT, 794 met the enrollment criteria for this HIT substudy. Enrollment was predicated on one of the following occurring in ICU: platelets less than 50 x 109/L, platelets decreased to 50% of ICU admission value (if admission value <100 x 109/L), any venous thrombosis, or if HIT was otherwise clinically suspected. Independently, 4Ts scores were completed in real time by research coordinators blinded to study drug and laboratory HIT results, and retrospectively by 2 adjudicators blinded to study drug, laboratory HIT results, and research coordinators' scores; the adjudicators arrived at consensus in all cases. Of the 763 patients, 474 had a central or local laboratory HIT test performed and had 4Ts scoring by adjudicators; 432 were scored by trained research coordinators. Heparin-induced thrombocytopenia was defined by a centrally performed positive serotonin release assay (SRA). Result(s): Of the 474 patients with central adjudication, 407 (85.9%) had a 4Ts score of 3 or lower, conferring a low pretest probability (PTP) of HIT; of these, 6 (1.5% [95% confidence interval, 0.7%-3.2%) had a positive SRA. Fifty-nine (12.4%) had a moderate PTP (4Ts score of 4-5); of these, 4 (6.8%) had a p

Published
2014

9. Long-Term Survival and Dialysis Dependency Following Acute Kidney Injury in Intensive Care: Extended Follow-up of a Randomized Controlled Trial.

Author

Bird S., Caf T., Weisbrodt L., Whereat S., Shehabi Y., Bass F., Edhouse P., Jenkins M., Jordon A., O'Connor A., Totaro R., Honeysett L., Inskip D., Sidoli R., Nair P., Reynolds C., Banerjee A., Kong J., Skelly C., Brown J., Gilder E., McArthur C., Newby L., Simmonds C., Henderson S., Mehrtens J., Sugden D., Kalkoff M., McGregor K., Shaw C., Morgan J., Gregory K., Sutton J., Garrett P., Buckley A., McDonald S., Joyce C., Harward M., Sexton G., Perkins K., Starr T., Flabouris A., O'Connor S., Rivett J., Turner A., McAllister R., Trubody V., Eastwood G., Peck L., Fletcher J., Ihle B., Ho S., Micallef J., Murray L., Botha J., Allsop S., Vuat J., Cattigan C., Elderkin T., Walker C., Galt P., Gillies A., Harley N., Barge D., Santamaria J., Holmes J., Smith R., Scheinkestel C., Donaldson H., Vallance S., French C., Bates S., Butler J., Breheny F., Palermo A., Dobb G., Chamberlain J., Lord P., Jun M., Yianni A., D'Haeseleer S., Lipman J., Dunlop R., Lassig-Smith M., Gallagher M., Cass A., Bellomo R., Finfer S., Gattas D., Lee J., Lo S., McGuinness S., Myburgh J., Parke R., Rajbhandari D., Mitchell I., Taylor E., Whyte R., Raza A., Nand K., Sara T., Millis D., Wong H., Harrigan P., Hardie M., Whitaker D., Bhonagiri D., Micallef S., Ellem K., Lintott M., Cole L., Cuzner C., Bird S., Caf T., Weisbrodt L., Whereat S., Shehabi Y., Bass F., Edhouse P., Jenkins M., Jordon A., O'Connor A., Totaro R., Honeysett L., Inskip D., Sidoli R., Nair P., Reynolds C., Banerjee A., Kong J., Skelly C., Brown J., Gilder E., McArthur C., Newby L., Simmonds C., Henderson S., Mehrtens J., Sugden D., Kalkoff M., McGregor K., Shaw C., Morgan J., Gregory K., Sutton J., Garrett P., Buckley A., McDonald S., Joyce C., Harward M., Sexton G., Perkins K., Starr T., Flabouris A., O'Connor S., Rivett J., Turner A., McAllister R., Trubody V., Eastwood G., Peck L., Fletcher J., Ihle B., Ho S., Micallef J., Murray L., Botha J., Allsop S., Vuat J., Cattigan C., Elderkin T., Walker C., Galt P., Gillies A., Harley N., Barge D., Santamaria J., Holmes J., Smith R., Scheinkestel C., Donaldson H., Vallance S., French C., Bates S., Butler J., Breheny F., Palermo A., Dobb G., Chamberlain J., Lord P., Jun M., Yianni A., D'Haeseleer S., Lipman J., Dunlop R., Lassig-Smith M., Gallagher M., Cass A., Bellomo R., Finfer S., Gattas D., Lee J., Lo S., McGuinness S., Myburgh J., Parke R., Rajbhandari D., Mitchell I., Taylor E., Whyte R., Raza A., Nand K., Sara T., Millis D., Wong H., Harrigan P., Hardie M., Whitaker D., Bhonagiri D., Micallef S., Ellem K., Lintott M., Cole L., and Cuzner C.

Abstract

Background:The incidence of acute kidney injury (AKI) is increasing globally and it is much more common than end-stage kidney disease. AKI is associated with high mortality and cost of hospitalisation. Studies of treatments to reduce this high mortality have used differing renal replacement therapy (RRT) modalities and have not shown improvement in the short term. The reported long-term outcomes of AKI are variable and the effect of differing RRT modalities upon them is not clear. We used the prolonged follow-up of a large clinical trial to prospectively examine the long-term outcomes and effect of RRT dosing in patients with AKI.Methods and Findings:We extended the follow-up of participants in the Randomised Evaluation of Normal vs. Augmented Levels of RRT (RENAL) study from 90 days to 4 years after randomization. Primary and secondary outcomes were mortality and requirement for maintenance dialysis, respectively, assessed in 1,464 (97%) patients at a median of 43.9 months (interquartile range [IQR] 30.0-48.6 months) post randomization. A total of 468/743 (63%) and 444/721 (62%) patients died in the lower and higher intensity groups, respectively (risk ratio [RR] 1.04, 95% CI 0.96-1.12, p = 0.49). Amongst survivors to day 90, 21 of 411 (5.1%) and 23 of 399 (5.8%) in the respective groups were treated with maintenance dialysis (RR 1.12, 95% CI 0.63-2.00, p = 0.69). The prevalence of albuminuria among survivors was 40% and 44%, respectively (p = 0.48). Quality of life was not different between the two treatment groups. The generalizability of these findings to other populations with AKI requires further exploration. Conclusion(s):Patients with AKI requiring RRT in intensive care have high long-term mortality but few require maintenance dialysis. Long-term survivors have a heavy burden of proteinuria. Increased intensity of RRT does not reduce mortality or subsequent treatment with dialysis.Trial registration:http://www.ClinicalTrials.gov NCT00221013 Please see later

Published
2014

10. Prospective informed consent substudy: PROTECT in Australia.

Author

Bird S., Boschert C., Ankers S., Rajbhandari D., Shepherd K., Galt P., Vallance S., Weisbrodt L., Vuat J., Caf T., O'Bree B., Elliot S., Bird S., Boschert C., Ankers S., Rajbhandari D., Shepherd K., Galt P., Vallance S., Weisbrodt L., Vuat J., Caf T., O'Bree B., and Elliot S.

Abstract

Rationale: While informed consent rates vary, they are perceived to be high in trials of the ANZICS-CTG and CCCTG. Understanding these rates helps to interpret local and overall recruitment efficiency, acceptance of the trial interventions and generalisability of the trial results. Objective(s): To prospectively study Australian informed consent rates during PROTECT which compares unfractionated and low molecular weight heparin for thromboprophylaxis. Method(s): Consecutive medical-surgical intensive care unit patients were approached if they met eligibility criteria. From 1 September 2008 to 27 February 2009, research co-ordinators in 10 participating Australian centres prospectively recorded who was approached for consent, by whom and the result. Result(s): Over six months, 81 patients were randomised. All informed consent was obtained a priori. No deferred or waived consent, or procedural authorisation was used. Most consent encounters were led by research co-ordinators alone (73/98, 74.5%); in 15 cases (15.3%) a physician (MD) was also involved, and in 10 cases (10.2%) the MD alone was involved. Consent rates ranged from 50.0 to 100.0% across centres (four to 22 patients were approached for an average centre recruitment of eight patients over six months). Consent rates were similar for research coordinators alone and MDs alone (83.6% vs 80.0%, P=0.67). Consent rates were similar when granted by substitute decision makers (75/88 [85.2%]) or by patients themselves (7/10 [70.0%], P=0.21). The consent rate was (82/98, 83.7%) and enrolment rate was (81/98, 82.7%). (Table Presented) Conclusion(s): Research co-ordinators perform most of the informed consent for the PROTECT trial and the overall consent rate is high.

Published
2010

11. Prospective informed consent substudy: PROTECT in Australia.

Author

Bird S., Boschert C., Ankers S., Rajbhandari D., Shepherd K., Galt P., Vallance S., Weisbrodt L., Vuat J., Caf T., O'Bree B., Elliot S., Bird S., Boschert C., Ankers S., Rajbhandari D., Shepherd K., Galt P., Vallance S., Weisbrodt L., Vuat J., Caf T., O'Bree B., and Elliot S.

Abstract

Rationale: While informed consent rates vary, they are perceived to be high in trials of the ANZICS-CTG and CCCTG. Understanding these rates helps to interpret local and overall recruitment efficiency, acceptance of the trial interventions and generalisability of the trial results. Objective(s): To prospectively study Australian informed consent rates during PROTECT which compares unfractionated and low molecular weight heparin for thromboprophylaxis. Method(s): Consecutive medical-surgical intensive care unit patients were approached if they met eligibility criteria. From 1 September 2008 to 27 February 2009, research co-ordinators in 10 participating Australian centres prospectively recorded who was approached for consent, by whom and the result. Result(s): Over six months, 81 patients were randomised. All informed consent was obtained a priori. No deferred or waived consent, or procedural authorisation was used. Most consent encounters were led by research co-ordinators alone (73/98, 74.5%); in 15 cases (15.3%) a physician (MD) was also involved, and in 10 cases (10.2%) the MD alone was involved. Consent rates ranged from 50.0 to 100.0% across centres (four to 22 patients were approached for an average centre recruitment of eight patients over six months). Consent rates were similar for research coordinators alone and MDs alone (83.6% vs 80.0%, P=0.67). Consent rates were similar when granted by substitute decision makers (75/88 [85.2%]) or by patients themselves (7/10 [70.0%], P=0.21). The consent rate was (82/98, 83.7%) and enrolment rate was (81/98, 82.7%). (Table Presented) Conclusion(s): Research co-ordinators perform most of the informed consent for the PROTECT trial and the overall consent rate is high.

Published
2010

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