延长治疗策略与标准治疗对大手术后高危患者持续性急性肾损伤的影响：随机对照单中心PrevProgAKI试验的研究方案

Effects of an extended therapeutic strategy versus standard-of-care therapy on persistent acute kidney injury in high-risk patients after major surgery: study protocol for the randomised controlled single-centre PrevProgAKI trial.

作者信息

Sadjadi Mahan, Strauß Christian, von Groote Thilo, Booke Hendrik, Schöne Ludwig Maximilian, Sauermann Leonie, Wempe Carola, Gerss Joachim, Kellum John, Meersch Melanie, Zarbock Alexander

机构信息

University Hospital Münster Department of Anesthesiology and Intensive Care Medicine, Münster, North Rhine-Westphalia, Germany.

University of Münster Institute of Biostatistics and Clinical Research, Münster, Nordrhein-Westfalen, Germany.

出版信息

BMJ Open. 2025 May 6;15(5):e097333. doi: 10.1136/bmjopen-2024-097333.

DOI:10.1136/bmjopen-2024-097333

PMID:40328648

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC12056649/

Abstract

INTRODUCTION

Persistent acute kidney injury (AKI) is associated with an increased morbidity and mortality. In patients with an already established AKI, the new urinary biomarker C-C motif chemokine ligand 14 (CCL14) can predict a persistent AKI. However, it is still unknown whether the implementation of nephroprotective measures in patients with an already established moderate/severe AKI can positively influence the trajectory of AKI and patients' outcome.

METHODS AND ANALYSIS

The PrevProgAKI trial is a randomised, controlled, single-centre trial designed to evaluate the effectiveness of nephroprotective measures in patients with established moderate/severe AKI. We aim to enrol 480 patients with moderate or severe AKI (Kidney Disease: Imroving Global Outcomes, KDIGO, stage 2 or 3) within 72 hours of major surgery. Eligible patients will be randomised to receive either standard of care (control group) or an extended therapeutic strategy that consists of different supportive measures (intervention group). The randomisation will be stratified by urinary CCL14 results (CCL14<1.3 ng/mL or CCL14≥1.3 ng/mL). Treating physicians will be blinded to the test results. The primary endpoint is a composite of the development of persistent severe (stage 3) AKI, need for renal replacement therapy or death within 72 hours. The key secondary endpoint is the composite of death, initiation of renal replacement therapy within 90 or persistent renal dysfunction at day 90.

ETHICS AND DISSEMINATION

The PrevProgAKI trial has been approved by the Ethics Committee of the Chamber of Physicians Westfalen-Lippe and the University of Muenster (no. 2021-569 f-S). Results will be disseminated widely and published in peer-reviewed journals, presented at conferences and will guide patient care and further research.

TRIAL REGISTRATION NUMBER

NCT05275218 (clinicaltrials.gov), first posted 11 March 2022.

摘要

引言

持续性急性肾损伤（AKI）与发病率和死亡率的增加相关。在已确诊AKI的患者中，新型尿生物标志物C-C基序趋化因子配体14（CCL14）可预测持续性AKI。然而，对于已确诊为中度/重度AKI的患者实施肾保护措施是否能对AKI的病程及患者预后产生积极影响仍不清楚。

方法与分析

PrevProgAKI试验是一项随机、对照、单中心试验，旨在评估肾保护措施对已确诊中度/重度AKI患者的有效性。我们的目标是在大手术后72小时内招募480例中度或重度AKI患者（肾脏病：改善全球预后，KDIGO，2期或3期）。符合条件的患者将被随机分配接受标准治疗（对照组）或包括不同支持措施的扩展治疗策略（干预组）。随机分组将根据尿CCL14结果进行分层（CCL14<1.3 ng/mL或CCL14≥1.3 ng/mL）。治疗医生将对检测结果不知情。主要终点是持续性重度（3期）AKI的发生、需要肾脏替代治疗或在72小时内死亡的复合终点。关键次要终点是死亡、在90天内开始肾脏替代治疗或在第90天出现持续性肾功能不全的复合终点。