RecruitingNCT07059715

Mic Mac: Micro- and Macrocirculatory Assessment During Cardiac Surgery in Patients at Risk of Vasoplegic Syndrome: A Prospective Study.

Mic Mac Study: A Prospective Study of Hemodynamic Coherence in Vasoplegic Syndrome After Cardiopulmonary Bypass


Sponsor

European Georges Pompidou Hospital

Enrollment

50 participants

Start Date

Feb 10, 2025

Study Type

OBSERVATIONAL

Conditions

Summary

This research focuses on understanding the vasoplegic syndrome after cardiac surgery under extracorporeal circulation and in the aftermath of your surgery in the ICU. The investigators evaluate variations in a number of clinical and biological parameters during cardiac surgery and in the 48 hours following resuscitation. In addition to all the monitors investigators usually use to monitor vital parameters during this type of procedure, investigators use sensors placed on the skin at the earlobe and palm of the hand to assess the quality of blood circulating in the body. The investigators would like to know if these observations help us to better understand the vasoplegic syndrome (persistent drop in blood pressure requiring the administration of medication to maintain normal blood pressure), a known but poorly understood complication following cardiac surgery under extracorporeal circulation. Extracorporeal circulation is the pump that keeps the blood circulating in your body when the heart is stopped while the surgeon works on the heart.


Eligibility

Min Age: 18 Years

Inclusion Criteria9

  • Have at least 3 point of the following risk factors for post-body circulation vasoplegic syndrome:
  • Acute or chronic heart failure with left ventricular ejection fraction< 40% (1 pt)
  • Complex cardiac surgery ( 2 pts)
  • Cardiovascular risk factors with a EuroSCORE> 4% (1 pt)
  • Chronic Kidney Disease Stage 4
  • Type 2 Diabetes Mellitus
  • Pre-operative heparin treatment
  • Hypothyroidism
  • Anti-hypertensive treatments including an ACE inhibitor, an angiotensin II receptor antagonist, a beta-blocker or Sacubitril

Exclusion Criteria13

  • Heart transplantation
  • Pre-operative hemodynamic instability
  • Pregnant women
  • Age <18
  • Pre-existing sepsis
  • Extracorporeal circulation support
  • Heartmate/Impella/Carmat patient
  • Hypothalamo-hypophyseal pathologies
  • Adrenal insufficiency
  • Anuric patient
  • Guardianship/ curatorship
  • Lack of social security coverage
  • Opposition to clinical research by patients or their families

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Locations(1)

Georges Pompidou European Hospital

Paris, France

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NCT07059715


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