ArticleCritical care and resuscitation : journal of the Australasian Academy of Critical Care Medicine2024
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.
Article in Critical care and resuscitation : journal of the Australasian Academy of Critical Care Medicine, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT04647396 (Biomarker- Guided Intervention to Prevent Acute Kidney Injury After Major Surgery. A Prospective Randomized Controlled Multicenter Trial), which is not on this map. Cited by 4 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Biomarker- Guided Intervention to Prevent Acute Kidney Injury After Major Surgery. A Prospective Randomized Controlled Multicenter Trial (BigpAK-2)
Who cites it
4 citing papers in PubMed.
- A Dynamic Approach to Assessing and Predicting AKI Risk in Patients with Aortoiliac Occlusive Disease Undergoing Aorto-Bifemoral Bypass.Diagnostics (Basel, Switzerland) · 2026Article
- Acute Kidney Injury Biomarkers in Perioperative Care: A Scoping Review of Clinical Implementation.Diagnostics (Basel, Switzerland) · 2025Review
- Preventing acute kidney injury and its longer-term impact in the critically ill.Intensive care medicine · 2025Review
- Ten tips on how to reduce iatrogenic acute kidney injury.Clinical kidney journal · 2025Review
Corrections and comments
- Erratum issued
Authors and funding
6 authors.
Funding
No grant is acknowledged in the PubMed record.
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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