A Preventive Care Strategy to Reduce Moderate or Severe Acute Kidney Injury After Major Surgery (BigpAK-2): A Multinational, Randomised Clinical Trial
In the multinational BigpAK-2 trial, using urinary stress biomarkers to identify high-risk patients and then applying a KDIGO-based preventive care bundle cut moderate-to-severe acute kidney injury after major surgery by roughly a third, with no increase in adverse events.
Background
Acute kidney injury is a common, serious complication of major surgery with no specific treatment, and recommended preventive measures are rarely applied systematically. BigpAK-2 tested whether identifying high-risk patients with urinary cell-cycle-arrest biomarkers ([TIMP-2]·[IGFBP7]) and then delivering KDIGO-guideline supportive care could prevent AKI.
Study design
BigpAK-2 (NCT04647396) was a multicenter randomized trial across 34 European hospitals. Adults undergoing major surgery flagged as high-risk by clinical factors plus tubular-stress biomarkers were randomized to usual care or a preventive bundle (advanced hemodynamic monitoring, optimization of volume status and hemodynamics, avoidance of nephrotoxic drugs and contrast, prevention of hyperglycemia). The primary outcome was moderate or severe AKI within 72 hours, by intention to treat.
Key findings
Among 1176 analyzed patients, moderate or severe AKI occurred in 14.4% of the intervention group versus 22.3% of controls (odds ratio 0.57, 95% CI 0.40–0.79; p=0.0002; number needed to treat 12). There were no differences in adverse events between groups.
Clinical implications
A biomarker-triggered KDIGO care bundle is a safe, effective way to reduce significant postoperative AKI in high-risk surgical patients, supporting the integration of stress-biomarker risk stratification followed by structured supportive care into perioperative practice.
Category
Research
Source
The Lancet
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