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1. Intensity of Continuous Renal-Replacement Therapy in Critically Ill Patients

Author

Bellomo, R, Cass, A, Norton, R, Gallagher, M, Lo, S, Su, S, Cole, L, Finfer, S, McArthur, C, McGuinness, S, Myburgh, J, Scheinkestel, C, Lee, J, Ali, D, Goldsmith, D, Banerjee, A, Bhonagiri, D, Blythe, D, Botha, J, Cade, J, Dobb, G, Eddington, J, Flabouris, A, French, C, Garrett, P, Henderson, S, Ihle, B, Joyce, C, Kalkoff, M, Lipman, J, Milliss, D, Mitchell, I, Morgan, J, Nair, P, Orford, N, Raza, A, Shehabi, Y, Tobin, A, Totaro, R, Turner, A, Wright, C, Little, L, Morrison, A, Regaglia, G, Shukla, R, Baigent, C, Emberson, J, Wheeler, D, Young, D, Billot, L, Bompoint, S, Heritier, S, Lo, SN, Pillai, A, Pandey, S, Ryan, S, Schmidt, M, Starzec, G, Vijayan, B, Ashley, R, Gissane, J, Malchukova, K, Ranse, J, Nand, K, Sara, T, Cheung, W, Fugaccia, E, Lawrence, P, Millis, D, Tan, J, Thankrishnan, G, Wong, H, Harrigan, P, Crowfoot, E, Hardie, M, Micallef, S, Brieva, J, Lintott, M, Seppelt, I, Gresham, R, Nikas, M, Weisbrodt, L, Bass, F, Boyle, M, Campbell, M, Hammond, N, Ankers, S, O'Connor, A, Potter, J, Rajbhandari, D, Dhiacou, V, Jovanovska, A, Munster, F, Breeding, J, Burns, C, Morrison, M, Pfeffercorn, C, Ritchie, A, Buhr, H, Eccleston, M, Parke, R, Bell, J, Newby, L, Mehrtens, J, West, C, Rudder, L, Sutton, J, Groves, N, McDonald, S, Jaspers, J, Harwood, M, Helyar, J, Mackie, B, Boots, R, Bertenshaw, C, Deans, R, Fourie, C, Lassig-Smith, M, Stuart, J, Edwards, J, O'Connor, S, Lewis, K, Rivett, J, Field, T, McAllister, R, Marsden, K, Mathlin, C, Mercer, I, O'Sullivan, K, Edington, J, Boschert, C, Smith, J, Graan, M, Ho, S, Fowler, N, McInness, J, Pratt, N, Elderkin, T, Fraser, M, Kinmonth, A, Barrett, J, Wilson, S, Galt, P, Burton, S, Culhane, C, Ioannidis, R, Roberston, M, Barge, D, Caf, T, Howe, B, Low, P, Holmes, J, Smith, R, Davies, A, Murray, L, Nevill, R, Vallance, S, Varley, S, White, V, Raunow, H, Palermo, A, Boardman, M, Chamberlain, J, Gould, A, McEntaggart, G, Perryman, S, Thomas, L, and In, RENALRTS

Subjects
Male, medicine.medical_specialty, Randomization, Critical Illness, medicine.medical_treatment, Hemodiafiltration, Kaplan-Meier Estimate, law.invention, Randomized controlled trial, law, Internal medicine, medicine, Humans, Prospective Studies, Renal replacement therapy, Prospective cohort study, Aged, business.industry, Acute kidney injury, General Medicine, Odds ratio, Acute Kidney Injury, Middle Aged, medicine.disease, Confidence interval, Surgery, Treatment Outcome, Female, business, Hypophosphatemia
Abstract

Background The optimal intensity of continuous renal-replacement therapy remains unclear. We conducted a multicenter, randomized trial to compare the effect of this therapy, delivered at two different levels of intensity, on 90-day mortality among critically ill patients with acute kidney injury. Methods We randomly assigned critically ill adults with acute kidney injury to continuous renal-replacement therapy in the form of postdilution continuous venovenous hemodiafiltration with an effluent flow of either 40 ml per kilogram of body weight per hour (higher intensity) or 25 ml per kilogram per hour (lower intensity). The primary outcome measure was death within 90 days after randomization. Results Of the 1508 enrolled patients, 747 were randomly assigned to higher-intensity therapy, and 761 to lower-intensity therapy with continuous venovenous hemodiafiltration. Data on primary outcomes were available for 1464 patients (97.1%): 721 in the higher-intensity group and 743 in the lower-intensity group. The two study groups had similar baseline characteristics and received the study treatment for an average of 6.3 and 5.9 days, respectively (P = 0.35). At 90 days after randomization, 322 deaths had occurred in the higher-intensity group and 332 deaths in the lower-intensity group, for a mortality of 44.7% in each group (odds ratio, 1.00; 95% confidence interval [CI], 0.81 to 1.23; P = 0.99). At 90 days, 6.8% of survivors in the higher-intensity group (27 of 399), as compared with 4.4% of survivors in the lower-intensity group (18 of 411), were still receiving renal-replacement therapy (odds ratio, 1.59; 95% CI, 0.86 to 2.92; P = 0.14). Hypophosphatemia was more common in the higher-intensity group than in the lower-intensity group (65% vs. 54%, P Conclusions In critically ill patients with acute kidney injury, treatment with higher-intensity continuous renal-replacement therapy did not reduce mortality at 90 days. (ClinicalTrials.gov number, NCT00221013.)

Published
2016

2. Critical illness due to 2009 A/H1N1 influenza in pregnant and postpartum women: population based cohort study

Author

Seppelt, I, Sullivan, E, Bellomo, R, Ellwood, D, Finfer, S, Howe, B, Knight, M, McArthur, C, McDonnell, N, McLintock, C, Morgan, TJ, Morrison, S, Nguyen, N, Peek, MJ, Pollock, W, Vaughan, G, Wang, YA, Web, SAR, Pettila, V, Bailey, M, Cooper, DJ, Cretikos, M, Davies, AR, Harrigan, PWJ, Hart, GK, Iredell, J, Mitchell, I, Nichol, A, Paterson, DL, Peake, S, Richards, B, Stephens, D, Turner, A, Yung, M, Homer, C, Pulver, LJ, Elliot, E, Ho, T, Thompson, J, Zurynski, Y, Callaway, L, Welsh, A, Oats, J, Gupta, B, Hague, W, McKee, A, McGuinness, S, Parke, R, Whitley, A, Newby, L, Simmonds, C, Eastwood, G, Peck, L, Fletcher, J, Boschert, C, Smith, J, Bennett, G, Ong, L, Nand, K, Reece, G, Sara, T, Ernest, D, Eliott, S, Sidhu, J, Carroll, A, Richmond, S, Wenck, D, Bishop, G, Ashley, R, Crowfoot, E, Henderson, S, Mehrtens, J, Fizzell, J, Faithfull, S, Baynes, T, Bersten, A, Ryan, E, Scroggs, S, Blythe, D, Palermo, A, Bortz, P, Lodding, K, Mott, M, Vagg, S, Frengley, R, Haslam, A, La Pine, M, Bingham, T, Cavill, D, Jennings, B, Parr, M, Micallef, S, Chaplin, J, Gregory, K, Presneill, J, Sutton, J, Horsley, C, Tai, J, Tilsley, A, Crozier, T, Galt, P, Reilly, M, Rockell, J, Hoyling, L, Weisbrodt, L, Bell, J, Flanagan, A, Laing, J, Duke, G, Parkes, M, Carr, J, Lambert, J, Boots, R, Lassig-Smith, M, McLaine, J, Thomas, J, Winter, S, Barge, D, Caf, T, Harley, N, MacIsaac, C, Bird, S, Raper, R, Chamberlain, J, Gould, A, McEntaggart, G, Gattas, D, Rajbhandari, D, Rees, C, Baker, S, Bicknell, A, Roberts, B, Nair, P, Reynolds, C, Evans, J, Gordon, G, Jones, L, Radtke, S, Andrews, L, Elder, R, Hicks, P, Mackle, D, Boyd, R, Mudaliar, Y, Nayyar, V, Skelly, C, Stachowski, E, Sterba, M, Johnson, B, and Robinson, J

Subjects
Adult, Critical Care, Adolescent, Critical Illness, Pregnancy Outcome, Australia, Prenatal Care, Cohort Studies, Young Adult, Influenza A Virus, H1N1 Subtype, Risk Factors, Pregnancy, General & Internal Medicine, Influenza, Human, Humans, Female, Pregnancy Complications, Infectious, New Zealand
Published
2010

3. 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

4. Calorie intake and patient outcomes in severe acute kidney injury: Findings from The Randomized Evaluation of Normal vs. Augmented Level of Replacement Therapy (RENAL) study trial.

Author

Nair P., Kalkoff M., West C., Morgan J., Rudder L., Sutton J., Garrett P., Groves N., McDonald S., Jennifer Palmer a., Joyce C., Harwood M., Helyar J., Mackie B., Lipman J., Boots R., Bertenshaw C., Deans R., Fourie C., Lassig-Smith M., Flabouris A., Edwards J., O'Connor S., Rivett J., Turner A., Field T., Marsden K., Mathlin C., Goldsmith D., Mercer I., O'Sullivan K., Edington J., Boschert C., Smith J., Ihle B., Graan M., Ho S., Botha J., Fowler N., McInness J., Pratt N., Orford N., Elderkin T., Fraser M., Kinmonth A., Wright C., Burton S., Culhane C., Galt P., Rutzou R., Roberston M., Barge D., Caf T., Howe B., Low P., Tobin A., Holmes J., Smith R., Murray L., Nevill R., Vallance S., Varley S., White V., French C., Little L., Raunow H., Blythe D., Palermo A., Dobb G., Boardman M., Chamberlain J., Gould A., McEntaggart G., Perryman S., Thomas L., Bellomo R., Cass A., Cole L., Finfer S., Gallagher M., Lee J., Lo S., McArthur C., McGuinness S., Myburgh J., Norton R., Scheinkestel C., Mitchell I., Ashley R., Gissane J., Malchukova K., Ranse J., Raza A., Nand K., Sara T., Millis D., Tan J., Wong H., Harrigan P., Crowfoot E., Hardie M., Bhonagiri D., Micallef S., Brieva J., Lintott M., Gresham R., Nikas M., Weisbrodt L., Shehabi Y., Bass F., Campbell M., Stockdale V., Ankers S., O'Connor A., Potter J., Totaro R., Rajbhandari D., Dhiacou V., Jovanovska A., Munster F., Davies A., Breeding J., Burns C., Banerjee A., Morrison M., Pfeffercorn C., Ritchie A., Buhr H., Eccleston M., Parke R., Bell J., Newby L., Henderson S., Mehrtens J., Nair P., Kalkoff M., West C., Morgan J., Rudder L., Sutton J., Garrett P., Groves N., McDonald S., Jennifer Palmer a., Joyce C., Harwood M., Helyar J., Mackie B., Lipman J., Boots R., Bertenshaw C., Deans R., Fourie C., Lassig-Smith M., Flabouris A., Edwards J., O'Connor S., Rivett J., Turner A., Field T., Marsden K., Mathlin C., Goldsmith D., Mercer I., O'Sullivan K., Edington J., Boschert C., Smith J., Ihle B., Graan M., Ho S., Botha J., Fowler N., McInness J., Pratt N., Orford N., Elderkin T., Fraser M., Kinmonth A., Wright C., Burton S., Culhane C., Galt P., Rutzou R., Roberston M., Barge D., Caf T., Howe B., Low P., Tobin A., Holmes J., Smith R., Murray L., Nevill R., Vallance S., Varley S., White V., French C., Little L., Raunow H., Blythe D., Palermo A., Dobb G., Boardman M., Chamberlain J., Gould A., McEntaggart G., Perryman S., Thomas L., Bellomo R., Cass A., Cole L., Finfer S., Gallagher M., Lee J., Lo S., McArthur C., McGuinness S., Myburgh J., Norton R., Scheinkestel C., Mitchell I., Ashley R., Gissane J., Malchukova K., Ranse J., Raza A., Nand K., Sara T., Millis D., Tan J., Wong H., Harrigan P., Crowfoot E., Hardie M., Bhonagiri D., Micallef S., Brieva J., Lintott M., Gresham R., Nikas M., Weisbrodt L., Shehabi Y., Bass F., Campbell M., Stockdale V., Ankers S., O'Connor A., Potter J., Totaro R., Rajbhandari D., Dhiacou V., Jovanovska A., Munster F., Davies A., Breeding J., Burns C., Banerjee A., Morrison M., Pfeffercorn C., Ritchie A., Buhr H., Eccleston M., Parke R., Bell J., Newby L., Henderson S., and Mehrtens J.

Abstract

Introduction: Current practice in the delivery of caloric intake (DCI) in patients with severe acute kidney injury (AKI) receiving renal replacement therapy (RRT) is unknown. We aimed to describe calorie administration in patients enrolled in the Randomized Evaluation of Normal vs. Augmented Level of Replacement Therapy (RENAL) study and to assess the association between DCI and clinical outcomes. Method(s): We performed a secondary analysis in 1456 patients from the RENAL trial. We measured the dose and evolution of DCI during treatment and analyzed its association with major clinical outcomes using multivariable logistic regression, Cox proportional hazards models, and time adjusted models. Result(s): Overall, mean DCI during treatment in ICU was low at only 10.9 +/- 9 Kcal/kg/day for non-survivors and 11 +/- 9 Kcal/kg/day for survivors. Among patients with a lower DCI (below the median) 334 of 729 (45.8%) had died at 90-days after randomization compared with 316 of 727 (43.3%) patients with a higher DCI (above the median) (P = 0.34). On multivariable logistic regression analysis, mean DCI carried an odds ratio of 0.95 (95% confidence interval (CI): 0.91-1.00; P = 0.06) per 100 Kcal increase for 90-day mortality. DCI was not associated with significant differences in renal replacement (RRT) free days, mechanical ventilation free days, ICU free days and hospital free days. These findings remained essentially unaltered after time adjusted analysis and Cox proportional hazards modeling. Conclusion(s): In the RENAL study, mean DCI was low. Within the limits of such low caloric intake, greater DCI was not associated with improved clinical outcomes. © 2014 Bellomo et al.; licensee BioMed Central Ltd.

Published
2014

5. 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

6. 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

7. 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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