Health TrialsbyHealthPanel

Personalisation of Mean Arterial Pressure in Adult Patients With Cardiogenic Shock

ConditionCardiogenic Shock
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCMC Ambroise Paré

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Personalized MAP

    Other intervention

    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

    Other intervention

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

Treatment groups

406 Participants
are divided into 2 treatment groups
Group A: Personalized MAPExperimental treatment 1 intervention
Group B: Standard MAPActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

1

Mortality in the intensive care unit (ICU), and in hospital

Time frame
28 days and 90 days after randomization
2

Length of stay in the ICU and in the hospital

Time frame
28 days and 90 days after randomization
3

Proportion of patients requiring cardiac mechanical circulatory support

Time frame
28 days after randomization
4

Proportion of patients requiring renal replacement therapy

Time frame
28 days after randomization

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

CMC Ambroise Paré

Lead sponsor

Source ClinicalTrials.gov
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