Study of the Expression of Endoplasmic Reticulum Stress During Extracorporeal Circulation in Humans

Not Applicable

• Conditions: Cardiac Surgery
• Interventions: Procedure: Cardiac surgery

• Registration Number: NCT03722979
• Lead Sponsor: University Hospital, Rouen

Brief Summary

The links between systemic inflammation, endothelial dysfunction and endoplasmic reticulum (ER) stress in pre-clinical models make it an interesting potential therapeutic target, but there are no data describing SRE during severe inflammation in humans .

For an approach to the study of SRE in humans in a situation of systemic inflammation, the analysis of patients benefiting from an extra-corporeal circulation for a programmed cardiac surgery would allow a study under well described conditions of inflammation, standardized, with the possibility for each patient to be his own witness. Compared to a situation of secondary inflammation (sepsis, acute pancreatitis, trauma ...) the analysis of the patients under CEC allows more precise description of the kinetics of the activation of the SRE because the beginning of the inflammatory mechanism is known with precision.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-08-09
• Status Verified: 2018-10
• Study First Submitted: 2018-10-25
• Study First Submitted QC: 2018-10-25
• Last Update Submitted: 2018-10-25
• Study First Posted: 2018-10-29
• Last Update Posted: 2018-10-29
• Primary Completion: 2020-03
• Study Completion: 2020-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 53

Inclusion Criteria

• Major patient (age ≥ 18 years)
• Patient undergoing cardiac surgery under extracorporeal circulation (duration of planned CEC > 1h)
• Informed person, having read and signed his consent preoperatively no later than the day before the procedure.
• Person affiliated with a social security scheme
• Effective contraception in women of childbearing potential. For menopausal women, the diagnosis of menopause will be based on the gynecological history of the patient (age> 50 years + amenorrhea for more than 12 months).

Exclusion Criteria

• Patient with urgent cardiac surgery
• Patient with cardiac surgery without extracorporeal circulation
• Patient with surgery under "mini-CEC"
• Patient with simple aortic valve replacement or single / double coronary artery bypass (CEC duration typically <1h)
• Patient with chronic autoimmune inflammatory disease, eg lupus, rheumatoid arthritis, inflammatory bowel disease ...
• Patient with progressive neoplastic disease
• Patient with underlying heart disease with left ventricular ejection fraction <30%
• Pregnant or lactating woman
• Person deprived of liberty by an administrative or judicial decision or protected major subject (under tutorship or curatorship)
• Patient participating in another interventional clinical trial

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
All patients	Cardiac surgery	-

Primary Outcome Measures

Name	Time	Method
Study of the variation of a marker of endoplasmic reticulum stress, between the pre- extracorporeal circulation (CEC) sample and the sample taken 2 hours after the release of extracorporeal circulation	2 hours after the release of extracorporeal circulation	ELISA technique (comparison of protein levels) + quantitative RT-PCR (comparison of normalized mRNA expression concentrations relative to a control gene).

Trial Locations

Locations (1)

ROUEN Hospital University; 🇫🇷 Rouen, France