Personalized mean arterial pressure targets guided by central venous pressure for adults with cardiogenic shock

Prospective, Randomized, Multicenter, Controlled Trial Assessing the Personalization of Mean Arterial Pressure in Adult Patients With Cardiogenic Shock

This will test whether setting each adult cardiogenic shock patient's blood pressure target based on their central venous pressure helps organs recover and improves survival compared with standard MAP targets.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 406 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: CMC Ambroise Paré (Academic / other)
• Locations: 11 sites (Amiens and 10 other locations)
• Trial ID: NCT07345559 on ClinicalTrials.gov

What this trial studies

This randomized interventional study compares a personalized MAP strategy that adjusts targets using measured or estimated central venous pressure (CVP) versus standard MAP management in adults with cardiogenic shock. Eligible patients are adults with cardiogenic shock (SCAI class ≥ C) who require inotropes/vasopressors and meet enrollment physiologic criteria. Patients are randomized early after presentation, and MAP is titrated in each arm according to the assigned strategy while monitoring organ function and hemodynamics. The study's main outcomes focus on organ dysfunction and survival during the acute shock period.

Who should consider this trial

Good fit: Adults (≥18 years) with cardiogenic shock (SCAI class C or higher) who require vasopressors/inotropes, have CVP ≥5 mmHg and MAP ≤70 mmHg at enrollment, and can provide consent or have appropriate emergency inclusion are the ideal candidates.

Not a fit: Patients with CVP <5 mmHg, MAP >70 mmHg at enrollment, catecholamine infusion >24 hours, chronic advanced kidney disease (stage G4/G5) or chronic dialysis, or already on mechanical circulatory support at inclusion are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, personalizing MAP by accounting for CVP could reduce organ dysfunction and lower mortality in cardiogenic shock.

How similar studies have performed: Observational and post‑hoc analyses have linked higher early MAP to better survival in cardiogenic shock, but prospective randomized testing of MAP targets personalized by CVP is largely novel.

Eligibility criteria

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.

Where this trial is running

Amiens and 10 other locations

• CHU d'Amiens-Picardie — Amiens, France (Not_yet_recruiting)
• Hôpital Henri Mondor — Créteil, France (Not_yet_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)

Study contacts

• Study coordinator: Armand MEKONTSO DESSAP, MD

Conditions Cardiogenic Shock; Cardiogenic shock; Inotropes; vasopressors; Mean arterial pressure; Central Venous Pressure; Organ dysfunction; Mortality