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
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
Accepted
Inclusion Criteria:
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 Criteria:
* 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
Primary outcome measure(s)
Change in blood neprilysin activity. — From enrollment (preoperative) to 48 hours after cardiac surgery Change from baseline in plasma neprilysin enzymatic activity measure at multiple timepoints with fluorimetry.
Unit of Measure: pmol/mL/min
Change in blood neprilysin concentration — From enrollment (preoperative) to 48 hours after cardiac surgery Change from baseline in plasma neprilysin concentration measured at multiple timepoints with mass spectrometry.
Unit of Measure: µg/L
Trial sites (1)
Facility
City
Region
Status
Georges Pompidou European Hospital
Paris
France
Recruiting
More European Georges Pompidou Hospital trials in France
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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