Mic Mac: Micro- and Macrocirculatory Assessment During Cardiac Surgery in Patients at Risk of Vasoplegic Syndrome: A Prospective Study.
Recruiting now
Conditions studied: Vasoplegic Syndrome of Cardiac Surgery
In brief
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.
Key facts
- Study ID
- NCT07059715
- Run by
- European Georges Pompidou Hospital
- People needed
- 50
- Starts
- 2025-02-10
- Expected to finish
- 2026-12-31
- Last updated by the study team
- 2025-07-11
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Georges Pompidou European Hospital — Paris, France (enrolling)
Full record on ClinicalTrials.gov
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