NCT03722979

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
53

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 7, 2018

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

October 25, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 29, 2018

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 6, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 6, 2019

Completed
Last Updated

April 17, 2026

Status Verified

April 1, 2026

Enrollment Period

8 months

First QC Date

October 25, 2018

Last Update Submit

April 13, 2026

Conditions

Cardiac Surgery

Outcome Measures

Primary Outcomes (1)

  • 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

    ELISA technique (comparison of protein levels) + quantitative RT-PCR (comparison of normalized mRNA expression concentrations relative to a control gene).

    2 hours after the release of extracorporeal circulation

Study Arms (1)

All patients

OTHER
Procedure: Cardiac surgery

Interventions

Cardiac surgeryPROCEDURE

The study will enroll patients having a planned cardiac surgery under extracorporeal circulation (CEC)

All patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ROUEN Hospital University

Rouen, 76000, France

Location

Related Publications (1)

  • Clavier T, Demailly Z, Semaille X, Thill C, Selim J, Veber B, Doguet F, Richard V, Besnier E, Tamion F. A Weak Response to Endoplasmic Reticulum Stress Is Associated With Postoperative Organ Failure in Patients Undergoing Cardiac Surgery With Cardiopulmonary Bypass. Front Med (Lausanne). 2021 Feb 15;7:613518. doi: 10.3389/fmed.2020.613518. eCollection 2020.

    PMID: 33659258RESULT

MeSH Terms

Interventions

Cardiac Surgical Procedures

Intervention Hierarchy (Ancestors)

Cardiovascular Surgical ProceduresSurgical Procedures, OperativeThoracic Surgical Procedures

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 25, 2018

First Posted

October 29, 2018

Study Start

July 7, 2018

Primary Completion

March 6, 2019

Study Completion

March 6, 2019

Last Updated

April 17, 2026

Record last verified: 2026-04

Locations

FR(1)