Dapagliflozin for Cardio-renal Protection After ICU Discharge: A Prospective, Randomized, Double Blinded, Multicenter Study: DAPA-ICU Trial

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
France
Hospital Saint Louis
RECRUITING
Paris
Saint Louis Hospital
NOT_YET_RECRUITING
Paris
Contact Information
Primary
François DEPRET, MD-PHD
francois.depret@aphp.fr
0142499570
Backup
Alexandre MEBAZAA, MD-PhD
alexandre.mebazaa@aphp.fr
01 49 95 80 85
Time Frame
Start Date: 2025-12-02
Estimated Completion Date: 2029-01-15
Participants
Target number of participants: 600
Treatments
Active_comparator: Dapagliflozin
One tablet of dapagliflozin 10 mg will be administered once daily from randomization and for 12 months period +/- 15 days..
Placebo_comparator: Placebo of dapagliflozin
One tablet of placebo of dapagliflozin 10 mg will be administered, per os, once daily from randomization and for 12 months period ± 15 days.
Related Therapeutic Areas
Sponsors
Leads: Assistance Publique - Hôpitaux de Paris

This content was sourced from clinicaltrials.gov