- Design
- Single-centre, prospective, randomised controlled trial
- Population
- 136 adults with sepsis in intensive care; 50 per group analysed
- Primary outcome
- Change in SOFA score over 5 days
- Effect
- No difference in SOFA change; day 5 LVEF 60.0% vs 55.0% (P < 0.001); 28-day mortality 26% vs 36% (P = 0.387)
A single-centre randomised trial in China enrolled 136 patients with sepsis in intensive care and gave standard treatment with or without dapagliflozin 10 mg daily for five days. Fifty patients per group were analysed. The primary outcome was change in SOFA (organ failure) score.
SOFA score change did not differ. On day 5 median left ventricular ejection fraction was higher with dapagliflozin (60.0% against 55.0%, P < 0.001). Mortality at 28 days was 26% (13 of 50) against 36% (18 of 50), not significant (P = 0.387). Adverse events were similar, although urine ketone grades were higher with the drug; no ketoacidosis occurred.
This is a preliminary study, with numbers too small for mortality, and the analysed groups were smaller than those randomised. SGLT2 inhibitors are not part of sepsis care, and ketoacidosis in the acutely ill remains a recognised concern.
- Do not start dapagliflozin in sepsis outside a trial on this evidence
- If a patient with sepsis is already on an SGLT2 inhibitor, follow your usual practice of holding it during acute illness
- Check ketones in acutely unwell patients on these drugs, even with normal glucose
- Treat the ejection fraction change as hypothesis-generating
Why it matters
SGLT2 inhibitors keep being tried in critical illness, and this gives a first look at tolerability.
Don't overread it
A preliminary single-centre trial cannot show that dapagliflozin improves outcomes in sepsis; the primary outcome was negative.
The statistics, in plain English
A P value of 0.387 for mortality means the difference between 26% and 36% could easily be chance with 50 patients per arm. The ejection fraction difference was significant but measured on day 5 only and does not show a lasting benefit or any effect on survival.
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