NCT07345559

Personalisation of Mean Arterial Pressure in Adult Patients With Cardiogenic Shock

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 406 (estimated)
• Sponsor: CMC Ambroise Paré · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 2026-03-26
• Primary completion: 2029-07-25
• Completion: 2029-07-25
• First posted: 2026-01-15
• Last updated: 2026-04-02

Locations

11 sites across 1 country: France