Dapagliflozin before cardiac surgery halved postoperative acute kidney injury

Design

Multicentre, double-blind, placebo-controlled randomised clinical trial

Population

784 adults undergoing elective cardiac surgery at seven Dutch hospitals; median age 68, 76% male, median eGFR 80 mL/min/1.73 m²

Primary outcome

Acute kidney injury by KDIGO criteria within 7 postoperative days

Effect

28% vs 52%; relative risk 0.54 (95% CI 0.45–0.65), P < .001

Seven Dutch hospitals randomised 784 adults having elective cardiac surgery to dapagliflozin 10 mg or placebo, starting the day before surgery and continuing to the second postoperative day — four doses in total. Acute kidney injury by KDIGO criteria within seven days occurred in 28% on dapagliflozin and 52% on placebo (relative risk 0.54, 95% CI 0.45–0.65, P < .001). Follow-up was 99% complete.

The size of that difference is the striking part. No drug has previously been shown to prevent acute kidney injury in this setting, and the placebo-arm rate of 52% shows how routine the problem is. Safety was unremarkable: atrial fibrillation occurred in 45% of each arm, and reoperation in 11% versus 10%.

Two caveats bound the enthusiasm. The outcome is a creatinine and urine-output definition, not dialysis or death, and a short course of an SGLT2 inhibitor changes creatinine handling in ways that can shift a creatinine-defined endpoint independently of tubular injury. And the population was 97% White with a median estimated GFR of 80 — a fitter, less diverse group than most Indian cardiac surgical lists.

• Ask the surgical and anaesthetic team whether a perioperative SGLT2 inhibitor protocol exists before changing practice unilaterally.
• Where a patient is already on an SGLT2 inhibitor for heart failure or diabetes, this trial is an argument against a reflexive preoperative hold.
• Record baseline creatinine and estimated GFR, and repeat at 48 hours and 7 days.
• Watch for euglycaemic ketoacidosis in any patient on an SGLT2 inhibitor through a fasting perioperative period — the trial's four-dose schedule does not remove that risk.
• Dapagliflozin is inexpensive and widely available in India, so cost is not the barrier to testing this locally.

Why it matters

Perioperative kidney injury has had no preventive drug at all; this is the first randomised claim to one.

Don't overread it

The endpoint was a creatinine and urine-output definition, not dialysis or death.

The statistics, in plain English

A relative risk of 0.54 with a confidence interval of 0.45 to 0.65 is a large effect measured precisely; the interval nowhere approaches 1.0. But the absolute difference matters more here — 24 fewer episodes per 100 patients, which is a number needed to treat of about four. That is unusually low, and unusually low numbers in single trials are the ones most often attenuated on replication.

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