An interventional study of Personalized MAP and Standard MAP in Cardiogenic Shock, sponsored by CMC Ambroise Paré. Recruiting at 11 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-29.
Sponsored by CMC Ambroise Paré · Not applicable, Interventional, and Other
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.
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.
296 studies on the registry are indexed under Shock, Cardiogenic; 134 are open to participants now.
This study's planned enrollment of 406 is above the median of 80 across 133 interventional studies indexed under Shock, Cardiogenic.
Browse Shock, Cardiogenic studies →CMC Ambroise Paré is the lead sponsor of 47 studies on the registry; 8 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Other: Personalized MAP
Other: Standard 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.
Patients receive blood pressure management aiming for a standard MAP target of 65-70 mmHg, according to international guidelines for cardiogenic shock management.
The primary endpoint will be a composite of mortality, use of cardiac mechanical circulatory support, and severe renal failure.
Time frame: 7 days and 28 days after randomization
Mortality in the intensive care unit (ICU), and in hospital
Time frame: 28 days and 90 days after randomization
Length of stay in the ICU and in the hospital
Time frame: 28 days and 90 days after randomization
Proportion of patients requiring cardiac mechanical circulatory support
Time frame: 28 days after randomization
Proportion of patients requiring renal replacement therapy
Time frame: 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
Time frame: 7 days after randomization
Duration of inotrope and vasopressor support
Time frame: 28 days after randomization
Use of mechanical ventilation
Time frame: 28 days after randomization
Number of ventilator-free days
Time frame: 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
Time frame: 5 days after randomization
Evolution of lactate levels
Time frame: 5 days after randomization
Evaluation of mottling score
Time frame: 5 days after randomisation
Evaluation of capillary refill time
Time frame: 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
Time frame: 5 days after randomization
Proportion of patients with sustained ventricular and/or supraventricular arrhythmias
Time frame: 5 days after randomization
Proportion of patients with stroke, non-cerebral ischemia, new or recurrent myocardial infarction
Time frame: 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.
Time frame: 28 days after randomization
Net clinical benefit at D28 (survival without thrombotic event or major bleeding).
Time frame: 28 days after randomization
Proportion of patients receiving new specific treatments after randomization during hospital stay
Time frame: 28 days after randomization
Plan to share: No
No publications or documents are linked to this record.
Started Mar 2026 (actual). Primary completion is estimated for Jul 2029, 39 months after the start.
Of 49 non-industry interventional studies with no phase under Shock, Cardiogenic, half reached primary completion within 39 months of starting (the median), counting those still running; a quarter within 24 and three quarters within 55. This study's planned 39 months is close to that.
Counting every sponsor, half of 53 studies reached it within 39 months; a quarter within 24 and three quarters within 55.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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CMC Ambroise Paré