A preventive care strategy to reduce moderate or severe acute kidney injury after major surgery (BigpAK-2); a multinational, randomised clinical trial.

Summary

In high-risk major surgical patients identified by clinical factors and urinary tubular stress biomarkers, a KDIGO-aligned preventive bundle reduced moderate-to-severe AKI within 72 hours (14.4% vs 22.3%; OR 0.57; NNT ≈12) without increasing adverse events. The pragmatic strategy focused on hemodynamic optimization, nephrotoxin avoidance, and glycemic control.

Key Findings

• Moderate/severe AKI within 72 hours was reduced from 22.3% to 14.4% (OR 0.57; NNT ≈12).
• No increase in adverse events including atrial fibrillation, significant bleeding, or reoperation.
• Biomarker-enriched selection plus KDIGO-based supportive care bundle achieved clinically meaningful benefit.

Clinical Implications

Perioperative teams should consider implementing biomarker-enriched risk stratification and standardized kidney-protection bundles (advanced hemodynamic monitoring, volume and pressure targets, nephrotoxin/contrast avoidance, hyperglycemia prevention) to reduce moderate-to-severe AKI.

Limitations

• Short primary outcome window (72 hours) may not capture longer-term kidney outcomes.
• Open-label pragmatic implementation could introduce performance bias; industry funding (BioMérieux).

Future Directions

Evaluate durability of kidney protection (e.g., MAKE90), cost-effectiveness, and implementation strategies across diverse health systems; assess additive value of specific biomarker thresholds and automated clinical decision support.