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.

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

SUBMITTER: von Groote T 

PROVIDER: S-EPMC11282373 | biostudies-literature | 2024 Jun

REPOSITORIES: biostudies-literature