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

IF 1.4 4区医学 Q3 CRITICAL CARE MEDICINE Critical Care and Resuscitation Pub Date : 2024-06-01 DOI:10.1016/j.ccrj.2024.03.001

Thilo von Groote MD , Moritz Fabian Danzer MSc , Melanie Meersch MD , Alexander Zarbock MD , Joachim Gerß PhD

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Abstract

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.

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预防大手术后急性肾损伤的生物标志物指导干预（BigpAK-2）研究的统计分析计划：国际多中心随机对照试验

本文介绍了生物标志物指导下预防大手术后 AKI 的干预试验（BigpAK-2）的统计分析计划。BigpAK.-2 试验是一项国际性、前瞻性、随机对照多中心研究。参与者BigpAK.-2 试验将招募大手术后入住重症监护室或高依赖性病房的患者，这些患者通过尿液生物标记物（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]) 确定为术后 AKI 的高危人群。干预患者被随机平均分配到标准护理组（对照组）或实施肾脏病：改善全球疗效》（KDIGO）指南的建议。KDIGO 护理包建议尽可能停用肾毒性药物，确保足够的血容量状态和灌注压，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，并在可能的情况下考虑放射对比剂的替代疗法。结果BigpAK-2研究调查了根据KDIGO 2012标准，生物标记物监测KDIGO护理包的实施是否能降低术后72小时内中度或重度AKI（2期或3期）的发生率。由于目前尚无特效治疗方法，因此预防 AKI 至关重要。BigpAK-2研究调查了一种预防大手术后AKI的有效方法。试验注册试验开始前已在clinicaltrials.gov; NCT04647396注册。

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来源期刊

Critical Care and Resuscitation CRITICAL CARE MEDICINE-

CiteScore

7.70

自引率

3.40%

发文量

审稿时长

>12 weeks

期刊介绍： ritical Care and Resuscitation (CC&R) is the official scientific journal of the College of Intensive Care Medicine (CICM). The Journal is a quarterly publication (ISSN 1441-2772) with original articles of scientific and clinical interest in the specialities of Critical Care, Intensive Care, Anaesthesia, Emergency Medicine and related disciplines. The Journal is received by all Fellows and trainees, along with an increasing number of subscribers from around the world. The CC&R Journal currently has an impact factor of 3.3, placing it in 8th position in world critical care journals and in first position in the world outside the USA and Europe.