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

University Hospital, Rouen

Status

Completed

Conditions

Cardiac Surgery

Treatments

Procedure: Cardiac surgery

Study type

Interventional

Funder types

Other

Identifiers

NCT03722979

2017/179/HP

Details and patient eligibility

About

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.

Enrollment

53 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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