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

C

Centre Hospitalier Universitaire, Amiens

Status

Unknown

Conditions

Vasoplegia
Endothelial Dysfunction

Study type

Observational

Funder types

Other

Identifiers

NCT02965339
RNI2015-05 (PI2015-05)

Details and patient eligibility

About

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.

Enrollment

100 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

  • 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)

Trial contacts and locations

1

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Central trial contact

Mohamed AIT AMER MEZIANE, PHD; Pierre-Grégoire GUINOT, Doctor

Data sourced from clinicaltrials.gov

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