Personalisation of Mean Arterial Pressure in Adult Patients With Cardiogenic Shock

NCT07345559 · tracked via the Priya Life Science France tracker

Sponsor

CMC Ambroise Paré

Phase

Not applicable

Started

2026-03-26

Last updated

2026-09-29

Condition(s) studied

Cardiogenic Shock

Investigational drug(s) / intervention(s)

Personalized MAPStandard MAP

Personalized MAP: Patients receive blood pressure management targeting a personalized MAP ranging from 65 mmHg + CVP to 75 mmHg + CVP, without exceeding 90 mmHg.CVP is measured via a central venous catheter positioned in the superior vena cava. After 48 hours, if tissue perfusion is restored, the MAP target may be reduced to 65-70 mmHg.

Standard MAP: Patients receive blood pressure management aiming for a standard MAP target of 65-70 mmHg, according to international guidelines for cardiogenic shock management.

Study summary

Cardiogenic shock is a life-threatening condition characterized by inadequate cardiac output, leading to organ hypoperfusion and high mortality. Maintaining mean arterial pressure (MAP) is crucial, but standard targets may be insufficient due to venous congestion. Central venous pressure (CVP) can help assess effective perfusion pressure. This study investigates whether a personalized MAP target adjusted by CVP improves organ function and survival compared to standard MAP management.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Inclusion Criteria: * Aged ≥18 years * Cardiogenic shock state, according to the consensus definition, * SCAI (Society for Cardiovascular Angiography and Interventions) classification ≥ C * Consent from the patient or close relative / trusted person or emergency inclusion procedure * Benefiting fromciary of a social security scheme Exclusion Criteria: * Catecholamine infusion for more than 24 consecutive hours; * CVP \< 5 mm Hg at inclusion; * MAP \> 70 mmHg at inclusion; * Chronic kidney disease stage G4 (defined by an eGFR between 15-29 ml/min/1.73 m²) or G5 (defined by an eGFR less than 15 ml/min/1.73 m²) according to the KDIGO CKD classification at inclusion; * Chronic dialysis or presence of renal replacement therapy criteria at inclusion ; * Recovered cardiopulmonary arrest within 7 days prior to inclusion; * Patient already on mechanical circulatory support at inclusion before enrollment (patients who receive support after inclusion will not be excluded); * Primary diagnosis of tamponade, pulmonary embolism, or septic shock; * Hypersensitivity to norepinephrine tartrate or to any of the following excipients: sodium chloride, hydrochloric acid or sodium hydroxide water for injectable preparations; * Absence of central venous access; * Known pregnancy or current breastfeeding; * Under legal guardianship, curatorship, or judicial protection.

Primary outcome measure(s)

The primary endpoint will be a composite of mortality, use of cardiac mechanical circulatory support, and severe renal failure. — 7 days and 28 days after randomization

Trial sites (11)

Facility	City	Region	Status
CHU d'Amiens-Picardie	Amiens	France	Not Yet Recruiting
Hôpital Henri Mondor	Créteil	France	Recruiting
Hôpital Privé Jacques Cartier	Massy	France	Not Yet Recruiting
CMC Ambroise Paré - Hartmann	Neuilly-sur-Seine	France	Recruiting
CHU d'Orléans	Orléans	France	Not Yet Recruiting
Hôpital Lariboisière	Paris	France	Not Yet Recruiting
Hôpital Cochin	Paris	France	Not Yet Recruiting
Clinique NCT + /Saint-Gatien	Saint-Cyr-sur-Loire	France	Not Yet Recruiting
Centre Cardiologique du Nord	Saint-Denis	France	Not Yet Recruiting
CHRU de Strasbourg	Strasbourg	France	Not Yet Recruiting
CHU de Toulouse	Toulouse	France	Not Yet Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07345559 on ClinicalTrials.gov ↗ ← All trials in France