Acute kidney injury (AKI) is a frequent and serious complication following major surgery. A new study has found that implementing a preventive care strategy, guided by urinary biomarkers to identify high-risk patients, significantly reduces the incidence of moderate to severe AKI without increasing adverse events. The findings come from the BigpAK-2 trial, a multinational, randomised clinical trial.
The investigator-initiated, open-label BigpAK-2 trial was conducted across 34 hospitals in Europe. The study enrolled 1,180 adult patients undergoing major surgery who were identified as being at high risk for AKI. This risk was determined by the presence of predefined clinical risk factors and elevated levels of urinary tubular stress biomarkers (TIMP-2 × IGFBP7).
Participants were randomly assigned on a 1:1 basis to either a preventive care strategy or usual care. The intervention was based on the Kidney Disease Improving Global Outcome (KDIGO) guidelines and included advanced haemodynamic monitoring, optimisation of volume status and haemodynamics, avoidance of nephrotoxic drugs and radiocontrast agents, and prevention of hyperglycaemia.
The primary outcome was the occurrence of moderate or severe AKI (KDIGO stage 2 or 3) within 72 hours after surgery.
In the intention-to-treat analysis of 1,176 patients, the primary outcome occurred in significantly fewer patients in the intervention group. Moderate or severe AKI was reported in 84 of 584 patients (14.4%) in the intervention arm, compared with 131 of 588 patients (22.3%) in the control arm (odds ratio 0.57; 95% CI 0.40–0.79; p=0.0002).
There were no significant differences in secondary outcomes, including major adverse kidney events at 90 days (MAKE90), mortality, or the need for renal replacement therapy. The rates of adverse events were similar between the groups. The most common events were atrial fibrillation (8.8% in the intervention group vs 9.7% in the control group) and haemodynamically relevant arrhythmias (7.2% vs 8.6%).
These findings suggest that a targeted, biomarker-guided preventive strategy can effectively reduce the burden of postoperative AKI in a high-risk population. The BigpAK-2 study group concluded, “Among adults at high risk for AKI undergoing major surgery, a preventive care strategy consisting of supportive measures and avoidance of nephrotoxins significantly reduced the occurrence of moderate or severe AKI without increasing adverse events.” The authors noted that further research is needed to evaluate the long-term implications and cost-effectiveness of this approach.
This study was funded by BioMérieux.
References
1. Zarbock A, Ostermann M, Forni L, et al. A preventive care strategy to reduce moderate or severe acute kidney injury after major surgery (BigpAK-2); a multinational, randomised clinical trial. Lancet. 2025. https://doi.org/10.1016/S0140-6736(25)01717-9
2. von Groote T, Meersch M, Romagnoli S, et al. Biomarker-guided intervention to prevent acute kidney injury after major surgery (BigpAK-2 trial): study protocol for an international, prospective, randomised controlled multicentre trial. BMJ Open. 2023;13:e070240. https://doi.org/10.1136/bmjopen-2022-070240
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