Dapagliflozin for Cardio-renal Protection After ICU Discharge

Launched by ASSISTANCE PUBLIQUE - HÔPITAUX DE PARIS · Jun 13, 2025

Keywords

ClinConnect Summary

This clinical trial is studying whether a medicine called dapagliflozin can help protect the heart and kidneys in patients who have been seriously ill in the intensive care unit (ICU). Many people who leave the ICU after a severe illness are at higher risk of heart and kidney problems, and even death, within the following year. This study aims to see if giving dapagliflozin after ICU discharge can reduce these risks and improve long-term health.

To join the trial, patients need to be adults who have spent time in the ICU with serious conditions requiring breathing support or medications to support the heart and blood pressure. They must be ready to leave the ICU and have certain markers in their blood that suggest some heart or kidney stress but not severe kidney failure. The trial will not include pregnant or breastfeeding women, people with certain infections, or those already taking dapagliflozin before ICU admission. Participants will receive medical care and be closely monitored to see if dapagliflozin helps protect their heart and kidneys after leaving the ICU. This study could offer new hope for improving recovery and long-term health after critical illness.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Age \>or= 18 years
• • Mechanical ventilation and/or vasopressors/inotropes for more than 24h during ICU stay
• • Patients ready to be discharged from ICU according to physician in charge
• • Inform consent form signed by the patient
• • NT-proBNP greater than 800 ng/L or BNP \> 90 ng/L and/or Estimated glomerular filtration rate (eGFR) between 25ml/min/1.73m² and 90ml/min/1.73m² of body-surface area (CKD-EPI formula) at inclusion.
• Exclusion Criteria:
• • Pregnancy
• • Ability to become pregnant and refusal to use effective contraception during all study treatment Women of childbearing potential (WOCBP)\*\* must agree to use adequate contraception according to Recommendations related to contraception and pregnancy testing in clinical trials, by Clinical Trial Facilitation Group (CTFG).
• The inclusion of WOCBP requires use of a highly effective contraceptive measure :
• • combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation
• • oral
• • intravaginal
• • transdermal
• • progestogen-only hormonal contraception associated with inhibition of ovulation
• • oral
• • injectable
• • implantable
• • intrauterine device (IUD)
• • intrauterine hormone-releasing system ( IUS)
• • bilateral tubal occlusion
• • vasectomised partner
• • sexual abstinence
• • The above mentioned risk mitigation measures (contraception) should be maintained during treatment and until the end of relevant systemic exposure.
• • \*\* a woman is considered of childbearing potential (WOCBP), i.e. fertile, following menarche and until becoming post-menopausal unless permanently sterile. Permanent sterilisation methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy.
• • A postmenopausal state is defined as no menses for 12 months without an alternative medical cause.
• • A high follicle stimulating hormone (FSH) level in the postmenopausal range may be used to confirm a post-menopausal state in women not using hormonal contraception or hormonal replacement therapy. However in the absence of 12 months of amenorrhea, a single FSH measurement is insufficient.
• • Breast feeding
• • Known hypersensitivity to dapagliflozin or any of the excipients
• • Patients treated with dapagliflozin before ICU admission
• • Patients with severe cirrhosis (Child-Pugh C)
• • Patients who admitted or who developed during their ICU stay a urinary tract infection or a perineal infection and patients at risk of skin infection near the perineum (e.g., a sacral pressure ulcer)
• • Estimated glomerular filtration rate (eGFR) below 25 ml per minute per 1.73 m2 of body-surface area (CKD -EPI formula).
• * Patient for whom treatment with Dapagliflozine is strongly recommended according to recent international guidelines:
• • patients with type 2 diabetes mellitus adults for whom the treatment is inadequately controlled as an adjunct to diet and exercise: either as monotherapy when metformin is considered inappropriate due to inadequate tolerance, or in addition to other medications for the treatment of type 2 diabetes,
• • symptomatic chronic heart failure with reduced or preserved left ventricular ejection fraction,
• • chronic kidney disease, in addition to standard therapy with a glomerular filtration rate (GFR) between 25 and 75 mL/min/1.73m² and a urinary albumin-to-creatinine ratio (ACR) between 200 and 5000 mg/g and treated for at least 4 weeks with an ACE inhibitor or angiotensin 2 receptor blocker (ARB II or sartan).
• • Patient without national health insurance, and patient on AME (state medical aid)
• • Persons deprived of liberty by a judicial or administrative decision
• • Participation in other interventional study