Sadjadi Mahan, Strauß Christian, von Groote Thilo, Booke Hendrik, Schöne Ludwig Maximilian, Sauermann Leonie, Wempe Carola, Gerss Joachim, Kellum John, Meersch Melanie, Zarbock Alexander
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.
BMJ Open. 2025 May 6;15(5):e097333. doi: 10.1136/bmjopen-2024-097333.
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.
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.
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.
NCT05275218 (clinicaltrials.gov), first posted 11 March 2022.
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。
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。
PrevProgAKI试验已获得威斯特法伦-利珀医师协会伦理委员会和明斯特大学的批准（编号2021-569 f-S）。研究结果将广泛传播并发表在同行评审期刊上，在会议上展示，并将指导患者护理和进一步研究。
NCT05275218（clinicaltrials.gov），首次发布于2022年3月11日。
