Mic Mac: Micro- and Macrocirculatory Assessment During Cardiac Surgery in Patients at Risk of Vasoplegic Syndrome: A Prospective Study.
Launched by EUROPEAN GEORGES POMPIDOU HOSPITAL · Jul 10, 2025
Trial Information
Current as of November 08, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying a condition called vasoplegic syndrome, which can happen after heart surgery when the blood pressure stays too low and needs medicine to keep it normal. The researchers want to better understand why this happens by carefully watching how blood flows in the body during and after surgery. They use special sensors placed on the skin of the earlobe and hand to measure blood flow, along with the usual monitors used during heart surgery.
The study is for adults aged 65 and older who are having complex heart surgery and have certain risk factors, like heart failure, diabetes, kidney problems, or are taking specific heart medicines. If you join the study, the doctors will observe and record your heart and blood flow measurements during the surgery and for two days afterward while you recover in the ICU. This extra monitoring does not change your treatment but helps doctors learn more about vasoplegic syndrome to improve care for future patients.
Gender
ALL
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
About European Georges Pompidou Hospital
The European Georges Pompidou Hospital (Hôpital Européen Georges-Pompidou, HEGP) is a leading healthcare institution located in Paris, France, dedicated to providing high-quality medical care and advancing medical research. As a prominent clinical trial sponsor, HEGP is committed to facilitating innovative research initiatives that enhance patient outcomes and contribute to the global medical community. With a multidisciplinary approach, HEGP collaborates with renowned researchers and healthcare professionals to conduct clinical trials across various therapeutic areas, ensuring adherence to rigorous ethical standards and regulatory compliance. The hospital's state-of-the-art facilities and expertise in patient care position it as a key player in the advancement of medical science and the translation of research findings into clinical practice.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Paris, France
Patients applied
Trial Officials
Helene NOUGUE, MCUPH
Principal Investigator
Georges Pompidou European Hospital
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported