RecruitingNot ApplicableNCT07345559

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


Sponsor

CMC Ambroise Paré

Enrollment

406 participants

Start Date

Mar 26, 2026

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria5

  • 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 Criteria12

  • 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.

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Interventions

OTHERPersonalized 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.

OTHERStandard MAP

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


Locations(11)

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

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NCT07345559


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