生物标志物引导的预防大手术后急性肾损伤干预研究（BigpAK-2）的统计分析计划：一项国际随机对照多中心试验。
Statistical analysis plan for the biomarker-guided intervention to prevent acute kidney injury after major surgery (BigpAK-2) study: An international randomised controlled multicentre trial.
作者信息
von Groote Thilo, Danzer Moritz Fabian, Meersch Melanie, Zarbock Alexander, Gerß Joachim
机构信息
Department of Anesthesiology, Intensive Care and Pain Medicine University, Hospital Münster, Münster, Germany.
Institute of Biostatistics and Clinical Research, University of Münster, Münster, Germany.
出版信息
Crit Care Resusc. 2024 Jun 21;26(2):80-86. doi: 10.1016/j.ccrj.2024.03.001. eCollection 2024 Jun.
OBJECTIVE
This article describes the statistical analysis plan for the Biomarker-guided intervention to prevent AKI after major surgery (BigpAK-2) trial.
DESIGN
Adaptive trial design with an interim analysis after enrolment of 618 evaluable patients.
SETTING
The BigpAK.-2 trial is an international, prospective, randomised controlled multicentre study.
PARTICIPANTS
The BigpAK-2 study enrols patients after major surgery who are admitted to the intensive care or high dependency unit and are at high-risk for postoperative AKI as identified by urinary biomarkers (tissue inhibitor of metalloproteinases-2 and insulin-like growth factor binding protein 7 ([TIMP-2]∗[IGFBP7]) will be enrolled.
INTERVENTION
Patients are randomly and evenly allocated to standard of care (control) group or the implementation of a nephroprotective care bundle (intervention group), as recommended by the Kidney Disease: Improving Global Outcomes (KDIGO) guidelines. The KDIGO care bundle recommends discontinuation of nephrotoxic agents if possible, ensuring adequate volume status and perfusion pressure, considering functional haemodynamic monitoring, regular monitoring of serum creatinine and urine output, avoiding hyperglycemia, and considering alternatives to radiocontrast procedures when possible.
RESULTS
The BigpAK-2 study investigates whether the biomarker-gudied implementation of the KDIGO care bundle reduces the incidence of moderate or severe AKI (stage 2 or 3), according to the KDIGO 2012 criteria, within 72 h after surgery.
CONCLUSION
AKI is a common and often severe complication after major surgery. As no specific treatments exist, prevention of AKI is of high importance. The BigpAK-2 study investigates a promising approach to prevent AKI after major surgery.
TRIAL REGISTRATION
The trial was registered prior to start at clinicaltrials.gov; NCT04647396.
目的
本文描述了生物标志物引导的重大手术后预防急性肾损伤（BigpAK - 2）试验的统计分析计划。
设计
采用适应性试验设计，在纳入618例可评估患者后进行中期分析。
背景
BigpAK - 2试验是一项国际、前瞻性、随机对照多中心研究。
参与者
BigpAK - 2研究纳入重大手术后入住重症监护病房或高依赖病房、经尿生物标志物确定为术后急性肾损伤高危患者（金属蛋白酶组织抑制剂 - 2和胰岛素样生长因子结合蛋白7（[TIMP - 2]∗[IGFBP7]））。
干预措施
按照改善全球肾脏病预后组织（KDIGO）指南的建议，患者被随机且平均分配至标准治疗（对照组）或实施肾脏保护护理套餐（干预组）。KDIGO护理套餐建议尽可能停用肾毒性药物，确保充足的容量状态和灌注压力，考虑进行功能性血流动力学监测，定期监测血清肌酐和尿量，避免高血糖，并尽可能考虑替代放射性造影检查的方法。
结果
BigpAK - 2研究调查根据KDIGO 2012标准，生物标志物引导实施的KDIGO护理套餐是否能降低术后72小时内中度或重度急性肾损伤（2期或3期）的发生率。
结论
急性肾损伤是重大手术后常见且往往严重的并发症。由于不存在特异性治疗方法，预防急性肾损伤至关重要。BigpAK - 2研究调查了一种有前景的重大手术后预防急性肾损伤的方法。
试验注册
该试验在启动前已在clinicaltrials.gov注册；NCT04647396。
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