Actively Recruiting

Phase 3
Age: 18Years +
All Genders
NCT07025629

Dapagliflozin for Cardio-renal Protection After ICU Discharge

Led by Assistance Publique - Hôpitaux de Paris · Updated on 2026-02-23

600

Participants Needed

2

Research Sites

162 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Several millions of patients are admitted to ICUs in Europe or USA each year. We and others, have shown that patients discharged from intensive care units (ICU) have a high incidence of cardiovascular and/or renal events and high mortality rate (22%) during the year following ICU discharge. Furthermore, a very recent meta-analysis found an excess hazard of late cardiovascular events which persists for at least 5 years following hospital discharge in sepsis survivors. Hence, many international ICU societies recommended investigating and improving post-ICU outcome with scarce guidance. We demonstrated that the proportion of ICU patients dying or presenting cardiovascular events within the year following ICU discharge is reported \~25% \[2\], reaching \~40% in some studies when considering patients with acute kidney injury (AKI). Plasma biomarkers at ICU discharge have good predictive value and patients with increased kidney or cardiovascular biomarkers display high risk of such events. In addition, we and others demonstrated that AKI or sub-AKI (patient not meeting the AKI definition but with an increased kidney related biomarker) could induce remote cardio-vascular injury and fibrosis, which may be involved in the poor long-term prognosis of ICU-acquired AKI. We hypothesize that strategy that prevent worsening in cardiovascular and/or renal injuries and/or in cardiovascular consequences of sub-AKI and AKI after ICU discharge improve long-term outcomes in ICU survivors. SGLT2 inhibitors are widely recognized as key drugs to protect the kidney and/or the myocardium in chronic diseases such as diabetes or heart failure. Cardio protective effect of SGLT2 inhibitors is optimal in patients with higher cardiac biomarker.

CONDITIONS

Official Title

Dapagliflozin for Cardio-renal Protection After ICU Discharge

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age ≥ 18 years
  • Mechanical ventilation and/or vasopressors/inotropes for more than 24 hours during ICU stay
  • Patients ready to be discharged from ICU according to physician in charge
  • Signed informed consent form
  • NT-proBNP greater than 800 ng/L or BNP > 90 ng/L and/or estimated glomerular filtration rate (eGFR) between 25 ml/min/1.73m² and 90 ml/min/1.73m² (CKD-EPI formula) at inclusion
Not Eligible

You will not qualify if you...

  • Pregnancy
  • Women able to become pregnant who refuse to use effective contraception during treatment
  • Breastfeeding
  • Known allergy to dapagliflozin or its ingredients
  • Previous treatment with dapagliflozin before ICU admission
  • Severe cirrhosis (Child-Pugh C)
  • Urinary tract or perineal infection during ICU stay or risk of perineal skin infection
  • eGFR below 25 ml/min/1.73m² (CKD-EPI formula)
  • Patients strongly recommended to receive dapagliflozin according to recent guidelines (e.g., uncontrolled type 2 diabetes, symptomatic chronic heart failure, chronic kidney disease with specified criteria)
  • No national health insurance or on state medical aid
  • Persons deprived of liberty by judicial or administrative decision
  • Participation in other interventional studies

AI-Screening

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Trial Site Locations

Total: 2 locations

1

Hospital Saint Louis

Paris, France, 75010

Actively Recruiting

2

Saint Louis Hospital

Paris, France, 75010

Not Yet Recruiting

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Research Team

F

François DEPRET, MD-PHD

CONTACT

A

Alexandre MEBAZAA, MD-PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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