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. 2024 Jun 21;26(2):80-86.
doi: 10.1016/j.ccrj.2024.03.001. eCollection 2024 Jun.

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

Thilo von Groote  1 , Moritz Fabian Danzer  2 , Melanie Meersch  1 , Alexander Zarbock  1 , Joachim Gerß  2 ; BigpAK-2 study group
Collaborators, Affiliations

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

Thilo von Groote et al. Crit Care Resusc. .

Erratum in

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.

Keywords: Acute kidney injury; Adaptive trial; Intensive care medicine; Perioperative medicine; Randomised controlled trial.

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Conflict of interest statement

The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Alexander Zarbock reports financial support was provided by bioMérieux Inc. Alexander Zarbock reports a relationship with AM Pharma, Baxter, Bayer, bioMerieux, Fresenius Medical Care, Guard Therapeutics, Novartis, Paion. that includes: funding grants and speaking and lecture fees. Melanie Meersch reports a relationship with Biomériux, Baxter and Fresenius Medical Care that includes: funding grants and speaking and lecture fees. If there are other authors, they declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.

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