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Randomized Controlled Trial
Intraoperative continuous renal replacement therapy during liver transplantation: a pilot randomized-controlled trial (INCEPTION).
- Constantine J Karvellas, Samantha Taylor, David Bigam, Norman M Kneteman, ShapiroA M JamesAMJDepartment of Surgery, Faculty of Medicine and Dentistry, University of Alberta, Edmonton, AB, Canada., Adam Romanovsky, GibneyR T NoelRTNDepartment of Critical Care Medicine, Faculty of Medicine and Dentistry, University of Alberta, 2-124E Clinical Science Building, 8440-112 Street, Edmonton, AB, T6G 2B7, Canada., Derek R Townsend, Glenda Meeberg, Timur Özelsel, Edward Bishop, and Sean M Bagshaw.
- Department of Critical Care Medicine, Faculty of Medicine and Dentistry, University of Alberta, 2-124E Clinical Science Building, 8440-112 Street, Edmonton, AB, T6G 2B7, Canada.
- Can J Anaesth. 2019 Oct 1; 66 (10): 1151-1161.
PurposeTo evaluate the feasibility of intraoperative continuous renal replacement therapy (IoCRRT) during liver transplantation (LT), in terms of recruitment, protocol adherence, and ascertainment of follow-up.MethodsIn this pilot randomized open-label controlled trial in adults receiving LT with a Model for End-Stage Liver Disease (MELD) score ≥ 25 and preoperative acute kidney injury (RIFLE - RISK or higher) and/or estimated glomerular filtration rate < 60 mL·min-1·1.73 m-2, patients were randomized to receive IoCRRT or standard of care (SOC). Primary endpoints were feasibility and adverse events. Primary analysis was intention-to-treat (n = 32) and secondary analysis was per-protocol (n = 28).ResultsThe trial was stopped early because of slow patient accrual and inadequate funding. Sixty patients were enrolled and 32 (53%) were randomized (n = 15 IoCRRT; n = 17 SOC). Mean (standard deviation) MELD was 36 (8), 81% (n = 26) had cirrhosis; 69% (n = 22) received preoperative RRT; 66% (n = 21) received LT from the intensive care unit. Four patients (n = 2 IoCRRT, n = 2 SOC) did not receive LT post-randomization. Seven patients (41%) allocated to SOC crossed over intraoperatively to IoCRRT. Three patients were lost to follow-up at one year. No adverse events occurred related to IoCRRT. There were no differences in survival at one year (IoCRRT, 71% [n = 10/14] vs SOC, 93% [n = 14/15]; risk ratio, 0.77; 95% confidence interval, 0.54 to 1.1). In the per-protocol analysis (n = 28 received IoCRRT after randomization - n = 20 IoCRRT, n = 8 SOC), one-year survival was 92% and perioperative complications were similar between groups. Only one patient was receiving dialysis one year after LT.ConclusionIn this pilot randomized trial, IoCRRT was feasible and safe with no difference in complications. Crossover rates were high. Despite high preoperative severity of illness, one-year survival was excellent. These data can inform the design of a larger multicentre trial.Trial Registrationwww.clinicalTrials.gov (NCT01575015); registered 12 April, 2012.
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