Personalisation of Mean Arterial Pressure in Adult Patients With Cardiogenic Shock (CARDIOPAM)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Cardiogenic Shock
• Intervention / Treatment: Other: Personalized MAP; Other: Standard MAP

Detailed Description

Cardiogenic shock is a severe and life-threatening condition. Its prognosis remains very poor with a high mortality rate (up to 50% in clinical series) despite recent therapeutic advances. Current recommendations suggest the use of inotropes and vasopressors to maintain tissue perfusion and prevent organ failure.

During cardiogenic shock, the mean arterial pressure (MAP) level is associated with survival. A post hoc analysis of a recent randomized trial found increased mortality among patients in cardiogenic shock whose average MAP was <70 mmHg during the first 36 hours after randomization, compared to patients with MAP ≥70 mmHg (58% vs. 29%, p<0.01). Another observational study found higher mortality among patients with a mean MAP <65 mmHg during the first 24 hours of shock compared to those with MAP ≥65 mmHg (57% vs. 28%, p<0.001). In this study, the incidence of renal failure was also inversely associated with MAP level. The optimal MAP target remains unknown during cardiogenic shock.

Due to the characteristic venous congestion, the effective perfusion pressure may be very low during cardiogenic shock despite MAP being within the usual target (65 mmHg). Furthermore, increased central venous pressure (CVP) is associated with higher mortality during cardiogenic shock. Considering venous congestion by measuring or estimating CVP is necessary to assess the effective perfusion pressure (MAP minus CVP) in order to protect against organ dysfunction. In this perspective, the MAP target should be increased by the value of the CVP.

The investigators hypothesize that personalizing the MAP target (to achieve an effective perfusion pressure of 65 mmHg) improves organ perfusion and survival during cardiogenic shock compared to the usual MAP target of 65 mmHg.

• Study Type: Interventional
• Enrollment (Estimated): 406
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Armand MEKONTSO DESSAP, MD; Phone Number: + 33 1 45 17 85 06; Email: armand.dessap@aphp.fr

Study Locations

• France
  • Amiens, France, 80000
    • Not yet recruiting
    • CHU d'Amiens-Picardie
    • Contact: Christophe BEYLS, MD
  • Créteil, France, 94010
    • Not yet recruiting
    • Hopital Henri Mondor
    • Contact: Armand MEKONTSO DESSAP, MD
  • Massy, France, 91300
    • Not yet recruiting
    • Hôpital Privé Jacques Cartier
    • Contact: Wulfran BOUGOUIN, MD
  • Neuilly-sur-Seine, France, 92200
    • Recruiting
    • CMC Ambroise Paré - Hartmann
    • Contact: Guillaume GERI, MD
  • Orléans, France, 45100
    • Not yet recruiting
    • CHU d'Orléans
    • Contact: Marc GORALSKI, MD
  • Paris, France, 75014
    • Not yet recruiting
    • Hopital Cochin
    • Contact: Alain CARIOU, MD
  • Paris, France, 75010
    • Not yet recruiting
    • Hopital Lariboisière
    • Contact: Bruno MÉGARBANE, MD
  • Saint-Cyr-sur-Loire, France, 37540
    • Not yet recruiting
    • Clinique NCT + /Saint-Gatien
    • Contact: Aurélien SEEMANN, MD
  • Saint-Denis, France, 93200
    • Not yet recruiting
    • Centre Cardiologique du Nord
    • Contact: Tristan MORICHAUBEAUCHANT, MD
  • Strasbourg, France, 67000
    • Not yet recruiting
    • CHRU de Strasbourg
    • Contact: Hamid MERDJI, MD
  • Toulouse, France, 31000
    • Not yet recruiting
    • CHU de Toulouse
    • Contact: Clément DELMAS, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Personalized MAP	Other: 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.
Active Comparator: Standard MAP	Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mortality in the intensive care unit (ICU), and in hospital		28 days and 90 days after randomization
Length of stay in the ICU and in the hospital		28 days and 90 days after randomization
Proportion of patients requiring cardiac mechanical circulatory support		28 days after randomization
Proportion of patients requiring renal replacement therapy		28 days after randomization
Proportion of patients with severe acute kidney injury (stage 2 and stage 3 according to KDIGO AKI classification)	Defined as stage 2 or stage 3 according to the Kidney Disease: Improving Global Outcomes (KDIGO) Acute Kidney Injury classification	7 days after randomization
Duration of inotrope and vasopressor support		28 days after randomization
Use of mechanical ventilation		28 days after randomization
Number of ventilator-free days		28 days after randomization
Evolution of the vasoactive inotropic score (VIS)	The clinical outcome is defined based on the Vasoactive Inotropic Score (VIS), according to published standard references	5 days after randomization
Evolution of lactate levels		5 days after randomization
Evaluation of mottling score		5 days after randomisation
Evaluation of capillary refill time		5 days after randomization
Evaluation of Sequential Organ Failure Assessment (SOFA) score	The clinical outcome is defined based on the Sequential Organ Failure Assessment (SOFA) score, according to published standard references	5 days after randomization
Proportion of patients with sustained ventricular and/or supraventricular arrhythmias		5 days after randomization
Proportion of patients with stroke, non-cerebral ischemia, new or recurrent myocardial infarction		28 days after randomization
Proportion of patients with major bleeding, defined according to the ISTH classification	Defined according to the International Society on Thrombosis and Haemostasis (ISTH) classification.	28 days after randomization
Net clinical benefit at D28 (survival without thrombotic event or major bleeding).		28 days after randomization
Proportion of patients receiving new specific treatments after randomization during hospital stay		28 days after randomization

Collaborators and Investigators

• Sponsor: CMC Ambroise Paré

Study record dates

Study Major Dates

• Study Start (Actual): March 26, 2026
• Primary Completion (Estimated): July 25, 2029
• Study Completion (Estimated): July 25, 2029

Study Registration Dates

• First Submitted: November 27, 2025
• First Submitted That Met QC Criteria: January 7, 2026
• First Posted (Actual): January 15, 2026

Study Record Updates

• Last Update Posted (Actual): April 2, 2026
• Last Update Submitted That Met QC Criteria: April 1, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Mortality; Inotropes; Organ dysfunction; Central Venous Pressure; Cardiogenic shock; vasopressors; Mean arterial pressure
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Infarction; Necrosis; Myocardial Ischemia; Myocardial Infarction; Ischemia; Shock; Pathological Conditions, Signs and Symptoms; Shock, Cardiogenic
• Other Study ID Numbers: 2024/01; 2024-A00253-44 (Registry Identifier: IDRCB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No