RecruitingNot Applicable

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

France50 participantsStarted 2025-02-10

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in blood neprilysin activity.

Timeframe: From enrollment (preoperative) to 48 hours after cardiac surgery

Change in blood neprilysin concentration

Timeframe: From enrollment (preoperative) to 48 hours after cardiac surgery

Trial details

NCT IDNCT07059715

SponsorEuropean Georges Pompidou Hospital

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2026-12-31

Contact for this trial

Hélène NOUGUE, MCU-PH

+331 56 09 25 94 helene.nougue@aphp.fr

View on ClinicalTrials.gov More Vasoplegic Syndrome of Cardiac Surgery trials