Actively Recruiting

Age: 18Years +
All Genders
Healthy Volunteers
NCT07059715

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

Led by European Georges Pompidou Hospital · Updated on 2025-07-11

50

Participants Needed

1

Research Sites

98 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Have at least 3 of the following risk factors for vasoplegic syndrome after extracorporeal circulation:
  • Acute or chronic heart failure with left ventricular ejection fraction below 40%
  • Complex cardiac surgery
  • Cardiovascular risk with EuroSCORE greater than 4%
  • Chronic kidney disease stage 4
  • Type 2 diabetes mellitus
  • Pre-operative heparin treatment
  • Hypothyroidism
  • Use of anti-hypertensive treatments including ACE inhibitors, angiotensin II receptor antagonists, beta-blockers, or Sacubitril
Not Eligible

You will not qualify if you...

  • Heart transplantation
  • Pre-operative hemodynamic instability
  • Pregnant women
  • Age under 18 years
  • Pre-existing sepsis
  • Extracorporeal circulation support
  • Use of heart assist devices such as Heartmate, Impella, or Carmat
  • Hypothalamo-hypophyseal pathologies
  • Adrenal insufficiency
  • Anuric patients
  • Under guardianship or curatorship
  • Lack of social security coverage
  • Opposition to clinical research by the patient or their family

AI-Screening

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Trial Site Locations

Total: 1 location

1

Georges Pompidou European Hospital

Paris, France, 75015

Actively Recruiting

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Research Team

H

Hélène NOUGUE, MCU-PH

CONTACT

B

Bernard Cholley, PUPH

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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