肝移植术中连续肾脏替代治疗的前瞻性随机对照研究（INCEPTION）
Intraoperative continuous renal replacement therapy during liver transplantation: a pilot randomized-controlled trial (INCEPTION).
机构信息
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.
Division of Gastroenterology (Liver Unit), University of Alberta, Edmonton, AB, Canada.
出版信息
Can J Anaesth. 2019 Oct;66(10):1151-1161. doi: 10.1007/s12630-019-01454-0. Epub 2019 Jul 26.
PURPOSE
To 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.
METHODS
In 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·1.73 m, 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).
RESULTS
The 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.
CONCLUSION
In 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 REGISTRATION
www.clinicalTrials.gov (NCT01575015); registered 12 April, 2012.
目的
评估术中持续肾脏替代治疗（IoCRRT）在肝移植（LT）中的可行性，包括招募、方案依从性和随访结果的确定。
方法
这是一项在成人接受 MELD 评分≥25 分且术前急性肾损伤（RIFLE - RISK 或更高）和/或估计肾小球滤过率＜60mL·min·1.73m 的 LT 患者中进行的单中心、随机、开放标签对照试验。患者被随机分配接受 IoCRRT 或标准护理（SOC）。主要终点为可行性和不良事件。主要分析为意向治疗（n=32），次要分析为方案治疗（n=28）。
结果
由于患者入组缓慢且资金不足，试验提前终止。共纳入 60 例患者，32 例（53%）被随机分配（n=15 例接受 IoCRRT；n=17 例接受 SOC）。平均（标准差）MELD 为 36（8），81%（n=26）为肝硬化；69%（n=22）术前接受 RRT；66%（n=21）从 ICU 接受 LT。4 例患者（n=2 例接受 IoCRRT，n=2 例接受 SOC）在随机分组后未接受 LT。7 例（41%）接受 SOC 的患者术中交叉至 IoCRRT。3 例患者在 1 年时失访。无与 IoCRRT 相关的不良事件发生。1 年生存率无差异（IoCRRT，71%[n=10/14]vs SOC，93%[n=14/15]；风险比，0.77；95%置信区间，0.54 至 1.1）。在方案治疗分析（n=28 例在随机分组后接受 IoCRRT- n=20 例接受 IoCRRT，n=8 例接受 SOC）中，1 年生存率为 92%，两组围手术期并发症相似。仅 1 例患者在 LT 后 1 年仍接受透析治疗。
结论
在这项初步随机试验中，IoCRRT 是可行且安全的，并发症无差异。交叉率较高。尽管术前病情严重，但 1 年生存率很高。这些数据可为更大规模的多中心试验设计提供信息。
试验注册
www.clinicalTrials.gov（NCT01575015）；2012 年 4 月 12 日注册。
Zotero 插件