Status:
WITHDRAWN
Role of Type 2 Diabetes in Potentiating the Inflammatory Response Post Extracorporeal Circulation After Cardiac Surgery
Lead Sponsor:
University Hospital Center of Martinique
Conditions:
Inflammatory Response
Extracorporeal Circulation; Complications
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
Adult cardiac surgery ensures the surgical treatment of valvular and coronary pathologies and of heart failure with the placement of ventricular assistance. Extracorporeal circulation (ECC) is one of ...
Detailed Description
Adult cardiac surgery provides surgical treatment of valvular, coronary, and heart failure pathologies with the installation of ventricular assistance. Extracorporeal circulation (ECC) is one of the m...
Eligibility Criteria
Inclusion
- Patients between 18 and 75 years old
- Type 2 diabetic patients (WHO definition and American Diabetes Association) according to the following criteria: fasting blood glucose ≥ 7.0 mmol / L (fasting = no caloric proportion for at least 8 h) or glycosylated hemoglobin level HbA1c ≥ 6, 5% (in adults), or blood sugar 2 hours after ingestion of 75 g of glucose ≥ 11.1 mmol / L, or random blood sugar ≥ 11.1 mmol / L, either at any time of the day, without seeing at the time of the last meal.
- Patients undergoing aortocoronary bypass surgery or valve replacement with extracorporeal circulation at the university hospital of Martinique
- Patients able to receive and understand information related to research and blood samples taken during treatment
- Patients able to freely express informed and written consent
- Patients supported by french social security
Exclusion
- Vulnerable people: people deprived of their liberty by a judicial or administrative decision, subjects admitted to a health or social protection establishment, major subjects under legal protection (guardianship or curatorship) or under the protection of justice, patients in situation emergency. Pregnant or lactating women, or women of childbearing potential without effective contraception. People with a state of health incompatible with the follow-up of the protocol (psychiatric disorders, uncontrolled disease), having cognitive disorders which do not allow the understanding of the study.
- Type 1 diabetic patient
- Patient who has a systemic inflammatory disease
- Patient who has an autoimmune disease
- Patient who has a cancer pathology
- Patient who has contraindications related to surgical operations in general such as general anesthesia
Key Trial Info
Start Date :
January 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2021
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04432337
Start Date
January 1 2021
End Date
March 1 2021
Last Update
July 20 2023
Active Locations (1)
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1
CHU de Martinique
Fort-de-France, Martinique, 97261