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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06136637
Other study ID # 2021-A02377-34
Secondary ID 2020/416/OB
Status Recruiting
Phase
First received
Last updated
Start date June 1, 2022
Est. completion date July 1, 2024

Study information

Verified date June 2024
Source University Hospital, Rouen
Contact Demailly Zoé, MD
Phone 0232882440
Email zoe.demailly@chu-rouen.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This is a prospective observational study of the evolution of the microcirculation and the sublingual glycocalyx in perioperative cardiac surgery under cardiopulmonary bypass. Our main objective is to evaluate the prognostic value of the variation of the thickness of the perioperative glycocalyx for the occurrence of a major complication in the first 24 hours after surgery.


Recruitment information / eligibility

Status Recruiting
Enrollment 77
Est. completion date July 1, 2024
Est. primary completion date July 1, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility - Patient of legal age (age = 18 years) - Patient undergoing scheduled cardiac surgery with cardiopulmoary bypass (CPB) (expected duration of CPB > 60 min) - Person informed with collection of non-opposition at the latest, the day before the operation - Person affiliated to a social security system

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
France Rouen University Hospital Rouen

Sponsors (2)

Lead Sponsor Collaborator
University Hospital, Rouen University of Rouen Normandie

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Glycocalyx thickness variation Change in glycocalyx thickness between the preoperative period and the postoperative period (2 hours after the end of cardiopulmonary bypass). Two hours after the end of cardiopulmonarybypass
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