Discontinuation or Continuation of SGLT-2 Inhibitors Before Cardiac Surgery: Impact on Postoperative Cardiovascular Outcomes - DISCO Study
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 434
- 试验地点
- 1
- 主要终点
- postoperative cardiovascular outcomes
研究概览
简要总结
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.
详细描述
Investigator team will compare patients who continue SGLT-2 inhibitors preoperatively with those who discontinue SGLT-2 inhibitors 3 days before surgery. Patients scheduled for elective cardiac surgery with cardiopulmonary bypass will be seen in an anesthesia consultation at least 4 days before surgery. During the consultation, the study will be proposed to the patient. After receiving written information and signing the informed consent form, baseline data, will be collected, and the patient will be randomized into one of the two study groups. The patient and the anesthesia and cardiac surgery teams will not be blinded. Indeed, Investigator team aim to conduct a pragmatic study that closely reflects clinical reality. Postoperatively, patients will be managed according to each service's usual practices. Investigator team's goal is to reflect real-world conditions. Following surgery, SGLT-2 inhibitors will be administrated once hemodynamics are stable. Five visits are scheduled in the protocol: 4 at 7 days before surgery, the day before surgery, at 7 days, upon hospital discharge, and 30 days after the intervention to assess the occurrence of the various outcome criteria.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •patients who have signed the informed consent form
排除标准
- •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
- •surgery for active endocarditis within the last 3 months
- •patients on preoperative mechanical circulatory support
- •heart transplant surgery or implantation of an LVAD (left ventricular assist device)
- •chronic kidney disease patients with a glomerular filtration rate below 25 mL/min/1.73m²
- •heart failure patients with a preserved ejection fraction, equal to or greater than 50
- •pregnant or breastfeeding women
- •minors or adults under legal protection (guardianship or conservatorship)
- •patients participating in another interventional study patients who do not understand or speak French.
研究组 & 干预措施
Continuation of SGLT-2 Inhibitors Before Cardiac Surgery
patients who continue SGLT-2 inhibitors preoperatively
干预措施: treatment continuation (Drug)
Continuation of SGLT-2 Inhibitors Before Cardiac Surgery
patients who continue SGLT-2 inhibitors preoperatively
干预措施: ketone levels (Diagnostic Test)
Discontinuation of SGLT-2 Inhibitors Before Cardiac Surgery
patients who discontinue SGLT-2 inhibitors 3 days before surgery
干预措施: treatment discontinuation (Drug)
Discontinuation of SGLT-2 Inhibitors Before Cardiac Surgery
patients who discontinue SGLT-2 inhibitors 3 days before surgery
干预措施: ketone levels (Diagnostic Test)
结局指标
主要结局
postoperative cardiovascular outcomes
时间窗: day 30 after surgery
composite criterion describing postoperative cardiovascular outcomes and will include: the occurrence of postoperative myocardial ischemia by day 2 (elevation of troponin I more than 218 times the laboratory threshold value for patients undergoing coronary artery bypass grafting or aortic valve replacement/repair surgery; the threshold will be 499 times the laboratory threshold value for other types of surgery) ; and/or the occurrence of postoperative low cardiac output syndrome in the ICU (defined by the administration of inotropes for more than 48 hours and/or the use of mechanical circulatory support); and/or rehospitalization by day 30 for heart failure (defined by the need for initiation or increase of diuretics and/or administration of inotropes and/or the use of invasive or non-invasive mechanical ventilation for acute pulmonary edema); and/or postoperative mortality by day 30
次要结局
- Euglycemic diabetic ketoacidosis(day 7 after surgery)
- Perioperative myocardial ischemia(day 2 after surgery)
- Postoperative low cardiac output syndrome(day 7 after surgery)
- Rehospitalization(day 30 after surgery)
- mortality(day 7 after surgery)
- mortality(day 30 after surgery)
- Acute kidney injury(day 7 after surgery)
- Quality of life assessed with an EQ5D test performed at day 30(day 30 after surgery)