Empagliflozin’s Microcirculation Effects in Cardiogenic Shock

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is an ancillary pilot study nested within the EMPASHOCK trial, conducted in the ICU setting to explore microcirculatory effects of empagliflozin in adults with cardiogenic shock. Real-time sublingual microcirculation is imaged with a CytoCam-IDF videomicroscope at baseline and 48 hours after treatment, alongside standard macrocirculatory measures. The study compares changes in microcirculatory parameters and survival to day 28 between patients who receive empagliflozin and those who do not, and includes a data collection plan for those unable to receive the drug. Eligibility requires prior enrollment in EMPASHOCK, ICU admission for CS, and consent for the ancillary study, with specific exclusions related to kidney function, prior SGLT2 inhibitor use, and other safety considerations.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Patient included in the main EMPASHOCK study
* Patient has signed a consent form for the ancillary study
* Patient is over 18 years old
* Hospitalized in the Intensive Care Unit for cardiogenic shock\*
* Has been or is on catecholamines for at least 12 hours for the treatment of cardiogenic shock\*\*
* Patient has the ability to take tablets orally
* Person is affiliated with or a beneficiary of a social security system

Exclusion Criteria:

* • GFR \< 20 ml/min/1.73m²

  * Chronic dialysis
  * Patient on SGLT2 inhibitors prior to ICU admission
  * Known allergy to SGLT2 inhibitors or any of their excipients (in particular, patients with hereditary galactose intolerance, total lactase deficiency, or glucose-galactose malabsorption syndrome).
  * Patient on lithium
  * Patient with type 1 diabetes
  * Patient in shock due to another cause or moribund patient (IGS 2 \> 90)
  * Cardiogenic shock cases excluded in the EMPASHOCK study: a. Heart transplant recipient or on a transplant list. b. Peripartum, adrenergic, valvular, restrictive, or post-embolic cardiomyopathy. c. Related to cardiotropic drug intoxication. d. Secondary to cardiac arrest where the patient remains comatose before inclusion.
  * Woman of childbearing age without effective contraception
  * Person referred to in Articles 10, 31, 32, 33, and 34 of EU Regulation 536/2014, specifically:
* Pregnant woman, woman in labor, or breastfeeding mother
* Minor person (not emancipated)
* Adult person subject to a legal protection measure (guardianship, curatorship, legal safeguard)

Where it's running

• Hôpitaux Universitaires de Strasbourg
  Strasbourg, France Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.