Effect at 3 Months of Early Empagliflozin Initiation in Cardiogenic Shock Patients on Mortality, Rehospitalization, Left Ventricular Ejection Fraction and Renal Function.

Launched by CENTRAL HOSPITAL, NANCY, FRANCE · May 24, 2023

Keywords

ClinConnect Summary

This clinical trial is investigating whether starting a medication called Empagliflozin early can help improve outcomes for patients experiencing cardiogenic shock, a serious condition where the heart can't pump enough blood. The researchers want to see if this treatment can reduce the risk of death, the need for hospitalization again, and improve heart function over three months compared to standard treatments.

To participate, you need to be an adult hospitalized in a critical care unit for cardiogenic shock, and on a medication called catecholamines for more than 12 hours but less than five days. However, there are certain conditions that would exclude you, such as having very poor kidney function or being on specific medications before being admitted. If you join the trial, you’ll receive either the Empagliflozin treatment or standard care, and the team will closely monitor your health to see how well the treatment works. This trial is crucial as it explores new ways to support patients in critical condition and improve their long-term health.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Adult patients hospitalized in critical cardiac unit care or Intensive care unit for a cardiogenic shock
• • "Who must have been or is on catecholamines for at least 12 hours for the treatment of cardiogenic shock.
• • Patients who are able to take oral tablets
• Exclusion Criteria:
• • GFR\< 20 ml/min/1.73m2.
• • Chronic dialysis.
• • Patient on SGLT2 inhibitors prior to admission to ICU or CCU.
• • Known allergy to SGLT2 inhibitors or to any of its excipients (in particular, patients with hereditary disorders of galactose intolerance, total lactase deficiency or glucose or galactose malabsorption syndrome)
• • Patients on lithium.
• • Patient in shock for another cause or moribund (SAPS2\> 90).
• * Specific cardiogenic shock context:
• • 1. cardiac transplant patient or on transplant list.
• • 2. peripartum, adrenergic, valvular, non ischemic, post embolic heart disease.
• • 3. related to cardiotropic drug intoxication.
• • 4. Secondary to a cardiac arrest for which the patient remains comatose prior to inclusion.
• • Women of childbearing age without effective contraception.
• • Person referred to in Articles 10, 31, 32, 33 and 34 of EU Regulation 536/2014 (Pregnant woman, parturient or breastfeeding mother, Minor (not emancipated), Adult person subject to a legal protection measure (guardianship, curatorship, safeguard of justice))