Personalisation of Mean Arterial Pressure in Adult Patients With Cardiogenic Shock

NCT ID: NCT07345559

Last Updated: 2026-01-21

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 406 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-03-15
• Study Completion Date: 2029-07-15

Brief 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.

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.

Conditions

Cardiogenic Shock

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Personalized MAP

Group Type: EXPERIMENTAL

Personalized MAP

Intervention Type: OTHER

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

Group Type: ACTIVE_COMPARATOR

Standard MAP

Intervention Type: OTHER

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

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

CMC Ambroise Paré

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

CHU d'Amiens-Picardie

Amiens, , France

Hôpital Henri Mondor

Créteil, , France

Hôpital Privé Jacques Cartier

Massy, , France

CMC Ambroise Paré - Hartmann

Neuilly-sur-Seine, , France

CHU d'Orléans

Orléans, , France

Hôpital Lariboisière

Paris, , France

Hôpital Cochin

Paris, , France

Clinique NCT + /Saint-Gatien

Saint-Cyr-sur-Loire, , France

Centre Cardiologique du Nord

Saint-Denis, , France

CHRU de Strasbourg

Strasbourg, , France

CHU de Toulouse

Toulouse, , France

Countries

France

Central Contacts

Armand MEKONTSO DESSAP, MD

Role: CONTACT

armand.dessap@aphp.fr

+ 33 1 45 17 85 06

Facility Contacts

Christophe BEYLS, MD

Role: primary

Armand MEKONTSO DESSAP, MD

Role: primary

Wulfran BOUGOUIN, MD

Role: primary

Guillaume GERI, MD

Role: primary

Marc GORALSKI, MD

Role: primary

Bruno MÉGARBANE, MD

Role: primary

Alain CARIOU, MD

Role: primary

Aurélien SEEMANN, MD

Role: primary

Tristan MORICHAUBEAUCHANT, MD

Role: primary

Hamid MERDJI, MD

Role: primary

Clément DELMAS, MD

Role: primary

Other Identifiers

2024-A00253-44

Identifier Type: REGISTRY

Identifier Source: secondary_id

2024/01

Identifier Type: -

Identifier Source: org_study_id