BACKGROUND: Acute kidney injury (AKI) is a common and important complication of major surgery, yet recommended preventive care is rarely administered. We used urinary biomarkers to identify patients at high risk of AKI and implemented a preventive care strategy to reduce AKI within 72 h after major surgery.
METHODS: BigpAK-2 was a multicentre randomised clinical trial done in 34 hospitals in Europe. Patients (aged =18 years) undergoing major surgery at high risk for AKI identified by predefined clinical risk factors and tubular stress biomarkers were randomly assigned to usual care or a preventive care strategy as per recommendations by the Kidney Disease Improving Global Outcome guidelines: advanced hemodynamic 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 within 72 h after surgery, assessed in the intention-to-treat population. Safety was assessed by comparing rates of adverse events between groups. This trial is registered with ClinicalTrials.gov, NCT04647396.
FINDINGS: From Nov 25, 2020, to June 21, 2024, 7873 patients were screened and 1180 (15·0%) were randomly assigned (589 [49·9%] to the intervention group and 591 [50·1%] to the control group). Among the 1176 patients available for the primary endpoint analysis, moderate or severe AKI occurred in 84 (14·4%) patients in the intervention group and in 131 (22·3%) patients in the control group (odds ratio 0·57 [95% CI 0·40-0·79; p=0·0002; number needed to treat 12 [7-33]). There were no differences in adverse events. The most common adverse events were atrial fibrillation (50 [8·8%] in the intervention group vs 56 (9·7%) in the control group), hemodynamically relevant arrhythmias (41 [7·2%] in the intervention group vs 50 [8·6%] in the control group), significant bleeding or haemorrhage (34 [6·0%] in the intervention group vs 31 [5·3%] in the control group), and unplanned return to the operating room (29 [5·1%] in the intervention vs 38 [6·5%] in the control group).
INTERPRETATION: 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.
FUNDING: BioMérieux.
| Specialty Area | Score |
|---|---|
| Hospital Doctor/Hospitalists | |
| Internal Medicine | |
| Nephrology |
A well-done and much needed RCT to determine whether preventive care strategies precluded developing AKI in high-risk patients undergoing major surgery. The findings suggest yes and the interventions are low-stakes with significant benefits. Highly recommend IM doctors familiarize themselves with this paper.
Interesting trial but complex. How clinically important is the primary outcome in this context (oliguria and creatinine)?
Not a surprising result: decreasing nephrotoxic exposures results in less AKI. I would have liked to see a propensity-matched group analysis. A short-term change in serum creatinine after contrast exposure does not predict long-term renal injury or the need for RRT. I wonder whether the same results would be found if this study examined longer-term follow-up of worsening renal function and RRT requirements.
As a hospitalist, the study is encouraging in that it suggests KDIGO guidelines for preventing AKI have benefit in high-risk patients following major surgery. These results are not easily generalizable as the definitions of high-risk surgery and risk of AKI are very specific. The endpoint of the study design was AKI using rising creatinine or falling urine output. Although the study was large and well designed and adherence to study protocol was excellent, the hard endpoints of RRT and death did not show any improvement with the intervention. Even hospital days and ICU days were similar in the intervention and control groups. When comparing patients with AKI and their severity, the intervention group did show shorter and milder AKI - moving patients from stage 2 to stage 1 severity. The numbers of patients with stage 3 (severe) were comparable.
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