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Dapagliflozin and Acute Kidney Injury Following Cardiac Surgery: A Randomized Clinical Trial
Maartina J P Oosterom-Eijmael1,2,3, Abraham H Hulst1,3,4, Nelson P Monteiro de Oliveira5
1Department of Anesthesiology, Amsterdam University Medical Center, Amsterdam, the Netherlands.
Importance:
Two percent to 50% of patients undergoing elective cardiac surgery experience acute kidney injury (AKI) postoperatively. Medications to prevent AKI after elective cardiac surgery have not been identified.
Objective:
In patients undergoing elective cardiac surgery, to evaluate whether initiating dapagliflozin 1 day prior to surgery reduces the incidence of AKI at 7 days after cardiac surgery, compared with placebo.
Design, Setting, And Participants:
Multicenter, double-blind, placebo-controlled randomized clinical trial conducted at 2 academic medical centers and 5 nonacademic hospitals in the Netherlands. Eligible participants were adults undergoing elective cardiac surgery. Enrollment occurred between June 8, 2023, and January 27, 2025. Final follow-up occurred May 16, 2025.
Intervention:
Patients were randomized 1:1 to receive either dapagliflozin (10 mg orally; n = 392) or placebo once daily (n = 392), beginning on the day before surgery and continuing through the second postoperative day (total of 4 doses).
Main Outcome And Measure:
The primary outcome was the between-group difference in AKI (defined as an increase in serum creatinine level by at least 0.3 mg/dL [26.5 µmol/L] within 48 hours after surgery, a 1.5-fold creatinine increase within 7 days of surgery, or urine output less than 0.5 mL/kg/h for 6 to 12 hours according to Kidney Disease: Improving Global Outcomes criteria) during the first 7 postoperative days.
Results:
Of 784 participants enrolled, 778 (99%) completed follow-up testing (median age, 68 [61-74] years; 76% male; 97% White; median body mass index, 27 [IQR, 25-30]; and median estimated glomerular filtration rate, 80 [IQR, 67-89] mL/min/1.73 m2). Compared with placebo, dapagliflozin reduced the incidence of AKI (28% vs 52%; relative risk, 0.54 [95% CI, 0.45-0.65]; P < .001) over 7-day follow-up after surgery. Atrial fibrillation and reoperation were the most frequent adverse events. The incidence of atrial fibrillation was 45% (176/392) in the dapagliflozin group vs 45% (176/392) in the placebo group, and the incidence of reoperation was 11% (43/392) vs 10% (39/392), respectively.
Conclusions And Relevance:
In patients undergoing elective cardiac surgery, 4 doses of dapagliflozin, beginning the day before surgery, reduced the incidence of AKI during the 7-day postoperative period.
Trial Registration:
ClinicalTrials.gov Identifier: NCT05590143.
Insights
Preoperative dapagliflozin significantly reduced acute kidney injury (AKI) in patients undergoing cardiac surgery. This study demonstrates a novel preventive strategy for AKI, a common postoperative complication.
Area of Science:
- Nephrology
- Cardiology
- Clinical Trials
Background:
- Acute kidney injury (AKI) affects 2%-50% of patients post-cardiac surgery.
- Effective preventive medications for postoperative AKI remain unidentified.
Purpose of the Study:
- To evaluate the efficacy of dapagliflozin in reducing AKI incidence after elective cardiac surgery.
- To compare dapagliflozin initiated preoperatively versus placebo.
Main Methods:
- A multicenter, double-blind, placebo-controlled randomized clinical trial.
- Adults undergoing elective cardiac surgery received dapagliflozin (10 mg daily) or placebo, starting 1 day before surgery for 4 doses.
- Primary outcome: AKI incidence within 7 days post-surgery.
Main Results:
- Dapagliflozin reduced AKI incidence from 52% to 28% (Relative Risk, 0.54; P < .001).
- No significant difference in atrial fibrillation or reoperation rates between groups.
- Trial NCT05590143.
Conclusions:
- Initiating dapagliflozin preoperatively is effective in preventing AKI in cardiac surgery patients.
- This represents a potential new therapeutic approach for AKI prevention in this high-risk population.
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