Evaluation of the Association Between Pre-existing Endothelial Dysfunction and the Onset of Vasoplegia During Cardiac Surgery With Cardiopulmonary Bypass

NCT02965339 | Unknown

• 1 other identifier: RNI2015-05 (PI2015-05)
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Cardiac surgery patients have many risk factors for endothelial dysfunction (hypertension, atherosclerosis, dyslipidemia, chronic renal failure ...). It is likely that a significant number of patients suffering from a preexisting endothelial dysfunction. This endothelial dysfunction can be assessed by a molecular approach (determination of NO, ICAM1, VCAM1, IL8, endothelial microparticles ...). Extracorporeal circulation with ischemia-reperfusion causes a breach of particularly important glycocalyx as ischemia-reperfusion injury is. No studies have evaluated the time course of the infringement, and its association with the immediate post-operative complications (SIRS, coagulopathy, vasoplegic syndrome, renal failure). Only one study has regained an association between endothelial dysfunction during cardiac bypass surgery and postoperative cardiac surgery vasoplegic syndrome. A study in noncardiac surgery has regained an association between endothelial dysfunction (assessed by a vasoplegia test) and postoperative acute renal failure. Thus there is some data in the literature to suggest that the occurrence of postoperative complications (SIRS, coagulopathy, capillary leak syndrome, acute circulatory failure vasoplegic and acute renal failure) may result from the interaction between a pre-existing endothelial dysfunction and "operative" aggression (extracorporeal circulation). The onset of complications result from an interaction that depends on the importance of endothelial dysfunction at baseline.

Conditions

Vasoplegia; Endothelial Dysfunction

Keywords

Vasoplegia; endothelial dysfunction; extracorporeal circulation; cardiac surgery

Outcome Measures

Primary Outcomes (1)

• The primary endpoint was the occurrence of vasoplegic syndrome

  The primary endpoint was the occurrence of vasoplegic syndrome correlate with markers of endothelial function following: IL8, P-selectin, von Willebrand factor precursor.

  6 months

Secondary Outcomes (6)

• Occurrence of vasoplegic syndrome

  6 months

• Marker of degradation glycocalyx:

  6 months

• Inflammatory markers:

  6 months

• Markers of blood coagulation

  6 months

• Complications

  6 months

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients ≥ 18 years, operated on for cardiac surgical myocardial revascularization (CABG) or surgical correction of aortic valve. Consent signed.

You may qualify if:

• Patients ≥ 18 years.
• Patient operated on for cardiac surgical myocardial revascularization (CABG) or surgical correction of aortic valve.
• Consent signed.

You may not qualify if:

• Standing arrhythmia.
• Pregnant woman.
• curative anticoagulation (warfarin, NANCO, heparin).
• Patient under guardianship.
• Patient Refused to participate.
• Cardiac surgery without CPB.
• bicuspid aortic valve.
• Participation in another study.
• preoperative sepsis.
• Minor or major, under guardianship or trusteeship (art L1121-5, L1121-8 and L1122 1-2)

Sponsors & Collaborators

• Centre Hospitalier Universitaire, Amiens: lead

Study Sites (1)

CHU De Caen

Caen, 14000, France

RECRUITING

MeSH Terms

Conditions

Vasoplegia

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Pierre-Grégoire GUINOT, Doctor

  CHU Amiens Picardie

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pierre-Grégoire GUINOT, Doctor

CONTACT

3 22 08 79 80; guinot.pierre-gregoire@chu-amiens.fr

Mohamed AIT AMER MEZIANE, PHD

CONTACT

3.22.08.83.84; aitamermeziane.mohamed@chu-amiens.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2016
• First Posted: November 16, 2016
• Study Start: November 1, 2016
• Primary Completion: September 1, 2018
• Study Completion: November 1, 2018
• Last Updated: May 1, 2018

Record last verified: 2018-04

Locations

FR (1)