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WithdrawnNCT02965339DYVAUpdated Jun 15, 2026

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

An observational study in Vasoplegia and Endothelial Dysfunction, sponsored by Centre Hospitalier Universitaire, Amiens. Withdrawn at 1 site in France. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-06-15.

Sponsored by Centre Hospitalier Universitaire, Amiens · Observational

Why this study was withdrawn
Difficult recruitment
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
0
Ages
18 Years to 70 Years
Sex
All
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Study 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.

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Conditions studied

  • Vasoplegia
  • Endothelial Dysfunction

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Keywords

  • Vasoplegia
  • endothelial dysfunction
  • extracorporeal circulation
  • cardiac surgery
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In context

Vasoplegia

48 studies on the registry are indexed under Vasoplegia; 19 are open to participants now.

Browse Vasoplegia studies →

Lead sponsor

Centre Hospitalier Universitaire, Amiens is the lead sponsor of 586 studies on the registry; 185 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

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)
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
0 participants (actual)
Patient registry
No
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What researchers measure

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.

    Time frame: 6 months

Secondary outcomes

  1. Occurrence of vasoplegic syndrome

    Occurrence of vasoplegic syndrome correlate with markers of endothelial function following: endothelial microparticles, Von Willebrand factor, VCAM1.

    Time frame: 6 months

  2. Marker of degradation glycocalyx:

    Marker of degradation glycocalyx: syndecan, heparan sulfate.

    Time frame: 6 months

  3. Inflammatory markers:

    Inflammatory markers: leukocytes, CRP, procalcitonin, albumin, TNF alpha, IL-10, IL-6, IL1beta

    Time frame: 6 months

  4. Markers of blood coagulation

    Markers of blood coagulation: Platelet count, PT, APTT, fibrinogen, D dimers, soluble complexes.

    Time frame: 6 months

  5. Complications

    Complications: cardiovascular (vasoplegic syndrome), kidney (KDIGO).

    Time frame: 6 months

  6. Death

    Death

    Time frame: 6 months

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Study locations

1 site
  • CHU De Caen
    Caen, Caen 14000, France
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 15, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02965339
Responsible party
Sponsor
First posted
Nov 16, 2016
Start date
Nov 2016 (estimated)
Primary completion
Sep 2018 (estimated)
Completion
Mar 2, 2020
Last update
Jun 15, 2026

Study contacts

Pierre-Grégoire GUINOT, Doctor
principal investigator · CHU Amiens Picardie

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.

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