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远程缺血预处理对心脏手术患儿的随机对照试验。

Randomized controlled trial of remote ischemic preconditioning in children having cardiac surgery.

机构信息

Pediatric Cardiology, Department of Pediatrics, Seattle Children's Hospital, 4800 Sand Point Way NE, Seattle, WA, 98105, USA.

University of Washington School of Medicine, Seattle, WA, 98115, USA.

出版信息

J Cardiothorac Surg. 2024 Jan 3;19(1):5. doi: 10.1186/s13019-023-02450-8.

Abstract

BACKGROUND

Children undergoing cardiac surgery are at risk for acute kidney injury (AKI) and cardiac dysfunction. Opportunity exists in protecting end organ function with remote ischemic preconditioning. We hypothesize this intervention lessens kidney and myocardial injury.

METHODS

We conducted a randomized, double blind, placebo controlled trial of remote ischemic preconditioning in children undergoing cardiac surgery. Pre-specified end points are change in creatinine, estimated glomerular filtration rate, development of AKI, B-type natriuretic peptide and troponin I at 6, 12, 24, 48, 72 h post separation from bypass.

RESULTS

There were 45 in the treatment and 39 patients in the control group, median age of 3.5 and 3.8 years, respectively. There were no differences between groups in creatinine, cystatin C, eGFR at each time point. There was a trend for a larger rate of decrease, especially for cystatin C (p = 0.042) in the treatment group but the magnitude was small. AKI was observed in 21 (54%) of control and 16 (36%) of treatment group (p = 0.094). Adjusting for baseline creatinine, the odds ratio for AKI in treatment versus control was 0.31 (p = 0.037); adjusting for clinical characteristics, the odds ratio was 0.34 (p = 0.056). There were no differences in natriuretic peptide or troponin levels between groups. All secondary end points of clinical outcomes were not different.

CONCLUSIONS

There is suggestion of RIPC delivering some kidney protection in an at-risk pediatric population. Larger, higher risk population studies will be required to determine its efficacy. Trial registration and date: Clinicaltrials.gov NCT01260259; 2021.

摘要

背景

接受心脏手术的儿童存在急性肾损伤(AKI)和心功能障碍的风险。通过远程缺血预处理保护终末器官功能的机会已经存在。我们假设这种干预可以减轻肾脏和心肌损伤。

方法

我们进行了一项随机、双盲、安慰剂对照的远程缺血预处理在接受心脏手术的儿童中的试验。预先指定的终点是在与旁路分离后 6、12、24、48 和 72 小时,肌酐、估计肾小球滤过率、AKI 发生、B 型利钠肽和肌钙蛋白 I 的变化。

结果

治疗组和对照组分别有 45 例和 39 例患者,中位年龄分别为 3.5 岁和 3.8 岁。两组在每个时间点的肌酐、胱抑素 C、eGFR 均无差异。治疗组尤其是胱抑素 C(p = 0.042)下降幅度较大,但幅度较小。对照组 AKI 发生率为 21 例(54%),治疗组为 16 例(36%)(p = 0.094)。调整基线肌酐后,治疗组与对照组 AKI 的比值比为 0.31(p = 0.037);调整临床特征后,比值比为 0.34(p = 0.056)。两组之间的利钠肽或肌钙蛋白水平没有差异。所有次要临床结局终点均无差异。

结论

有迹象表明,RIPC 在高危儿科人群中提供了一定的肾脏保护作用。需要更大、风险更高的人群研究来确定其疗效。试验注册和日期:Clinicaltrials.gov NCT01260259;2021 年。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/faf5/10765905/650c8686132b/13019_2023_2450_Fig1_HTML.jpg

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