Monitoring small- and large-vessel blood flow during heart surgery in patients at risk of vasoplegic syndrome
Official title: Mic Mac Study: A Prospective Study of Hemodynamic Coherence in Vasoplegic Syndrome After Cardiopulmonary Bypass
Run by European Georges Pompidou Hospital · NCT07059715 · Data updated 2026-11-12
We will test whether adding earlobe and palm skin sensors plus clinical and blood measurements during and for 48 hours after heart surgery helps understand and predict vasoplegic syndrome in patients at higher risk.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 50 (estimated) |
| Sponsor | European Georges Pompidou Hospital Academic / other |
| Locations | 1 site (Paris) |
| Status | Recruiting |
| Started | February 10, 2025 |
| Main results expected | December 31, 2026 |
| Study ends | December 31, 2026 |
| Registry record updated | July 11, 2025 |
| Trial ID | NCT07059715 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults having cardiac surgery with extracorporeal circulation who meet the inclusion criteria (at least three specified risk factors and no exclusion criteria) are the intended participants.
✕Probably not a fit
Patients who are preoperatively unstable, already on extracorporeal support or ventricular assist devices, pregnant, under guardianship, or who do not meet the risk profile are unlikely to gain benefit from participation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a prospective observational project enrolling patients undergoing cardiac surgery with extracorporeal circulation who meet risk criteria for post-bypass vasoplegic syndrome. Investigators will record standard hemodynamic monitors and add noninvasive skin sensors on the earlobe and palm, while collecting clinical and biological samples during surgery and for 48 hours in the ICU. The goal is to compare macrocirculatory and microcirculatory signals and identify metabolic or signaling pathways linked to loss of hemodynamic coherence and persistent hypotension. Findings aim to clarify mechanisms behind vasoplegia and suggest earlier markers or targets for future interventions.
Why it matters
Potential benefit: If successful, this work could help doctors detect patients at risk of vasoplegia earlier and guide treatments to prevent prolonged low blood pressure and organ injury.
How similar studies have gone: Related microcirculation monitoring approaches have yielded useful data in sepsis and perioperative care, but combining skin sensors with metabolic pathway analysis specifically for post-cardiopulmonary bypass vasoplegia is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
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Georges Pompidou European Hospital
Paris, France Recruiting
Study contacts
- Principal investigator: Helene NOUGUE, MCUPH — Georges Pompidou European Hospital
- Study coordinator: Hélène NOUGUE, MCU-PH
- Email: helene.nougue@aphp.fr
- Phone: +331 56 09 25 94
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Comparing vasopressin and norepinephrine for treating low blood pressure after heart surgery
This study is testing whether vasopressin or norepinephrine works better to treat low blood pressure in patients who develop complications after heart surgery.
-
HPA (stress hormone) function in adults who develop vasoplegia after cardiac surgery
This project will test whether the body's stress-hormone system (the HPA axis and cortisol response) is altered in adults who develop vasoplegic syndrome after heart surgery.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.