Discontinuation or Continuation of SGLT-2 Inhibitors Before Cardiac Surgery
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital, Toulouse
About this trial
SGLT-2 inhibitors are recommended treatments for managing heart failure patients. In cases of surgery, it is recommended to stop the treatment 3 days before surgery due to the risk of postoperative euglycemic diabetic ketoacidosis. However, several data suggest that it may be beneficial to maintain SGLT-2i treatment given the possibility of improving postoperative cardiovascular outcomes. Investigator team wish to conduct a randomized controlled trial to test the hypothesis that preoperative maintenance of SGLT-2i is superior to discontinuing them 3 days before surgery in improving postoperative cardiovascular outcomes.
Eligibility criteria
Qualifiers
Adult patients scheduled to undergo cardiac surgery with cardiopulmonary bypass
patients treated with SGLT-2 inhibitors, including combined treatment with metformin, for at least 4 weeks
heart failure patients with a left ventricular ejection fraction strictly below 50%
patients enrolled in a social security scheme or equivalent
Disqualifiers
Treatment with SGLT-2 inhibitors initiated less than 4 weeks ago and other than empagliflozine or dapagliflozine
patients with a contraindication to SGLT-2 inhibitors: hypersensitivity, type 1 diabetes mellitus, and renal impairment with an estimated glomerular filtration rate below 25 mL/min/1.73 m²
acute conditions likely to call into question the continuation of SGLT2 inhibitor therapy (alone or in combination) at the time of inclusion, including in particular: shock state or acute tissue hypoxia (episode of hyperlactatemia > 3 mmol/L within 7 days prior to inclusion); acute kidney injury within the previous 7 days (KDIGO stage ≥2); severe hepatocellular failure (factor V level < 50%); acute alcohol intoxication within the previous 7 days or active alcohol use disorder without withdrawal
surgery scheduled within less than 3 days
Trial design
Treatments tested in this trial
- treatment discontinuation
- treatment continuation
- ketone levels
Treatment groups
434 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov