NCT07059715 Mic Mac: Micro- and Macrocirculatory Assessment During Cardiac Surgery in Patients at Risk of Vasoplegic Syndrome: A Prospective Study.
| NCT ID | NCT07059715 |
| Status | Recruiting |
| Phase | — |
| Sponsor | European Georges Pompidou Hospital |
| Condition | Vasoplegic Syndrome of Cardiac Surgery |
| Study Type | OBSERVATIONAL |
| Enrollment | 50 participants |
| Start Date | 2025-02-10 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 50 participants in total. It began in 2025-02-10 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility 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
Contact & Investigator
Helene NOUGUE, MCUPH
PRINCIPAL INVESTIGATOR
Georges Pompidou European Hospital
Frequently Asked Questions
Who can join the NCT07059715 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Vasoplegic Syndrome of Cardiac Surgery. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07059715 currently recruiting?
Yes, NCT07059715 is actively recruiting participants. Contact the research team at helene.nougue@aphp.fr for enrollment information.
Where is the NCT07059715 trial being conducted?
This trial is being conducted at Paris, France.
Who is sponsoring the NCT07059715 clinical trial?
NCT07059715 is sponsored by European Georges Pompidou Hospital. The principal investigator is Helene NOUGUE, MCUPH at Georges Pompidou European Hospital. The trial plans to enroll 50 participants.