Dapagliflozin and Acute Kidney Injury Following Cardiac Surgery: A Randomized Clinical Trial.
Summary
In this multicenter, double-blind randomized clinical trial of 784 adults undergoing elective cardiac surgery, four perioperative doses of dapagliflozin reduced postoperative AKI from 52% to 28% compared with placebo (relative risk 0.54, 95% CI 0.45-0.65; P<.001). Follow-up testing was completed in 99% of participants, and atrial fibrillation and reoperation rates were similar between groups.
Key Findings
- Among 778 participants with follow-up data, AKI occurred in 28% with dapagliflozin versus 52% with placebo.
- The relative risk of AKI was 0.54 with dapagliflozin, with a 95% CI of 0.45-0.65 and P<.001.
- Atrial fibrillation occurred in 45% of each group, while reoperation occurred in 11% with dapagliflozin and 10% with placebo.
Clinical Implications
Dapagliflozin initiated one day before elective cardiac surgery may become a candidate strategy for preventing postoperative AKI. Before routine adoption, clinicians should consider patient selection, perioperative volume status, renal function, risks associated with sodium-glucose cotransporter 2 inhibition, and confirmation in other populations and healthcare systems.
Why It Matters
This is a large, registered, multicenter randomized trial addressing a common and clinically consequential complication for which preventive pharmacotherapy has been lacking. The magnitude of benefit could change perioperative cardiac-surgery kidney-protection strategies, although external validation and broader safety assessment remain necessary.
Limitations
- The study was conducted in the Netherlands and included a population that was 97% White, which may limit generalizability.
- The intervention began only one day before surgery and was evaluated during a short seven-day postoperative period.
- The abstract does not establish effects on longer-term kidney function, mortality, or patient-centered recovery outcomes.
Future Directions
Future studies should replicate the findings in diverse international populations, evaluate longer-term renal and survival outcomes, define safety in patients with reduced kidney function or diabetes, and compare dapagliflozin with other perioperative kidney-protection strategies.
Study Information
- Study Type
- RCT
- Research Domain
- Prevention
- Evidence Level
- I - Large, multicenter, double-blind, placebo-controlled randomized clinical trial with prospective registration.
- Study Design
- OTHER