VasoplegiaDYVANCT02965339
Evaluation of the Association Between Pre-existing Endothelial Dysfunction and the Onset of Vasoplegia During Cardiac Surgery With Cardiopulmonary Bypass
An observational study of Vasoplegia and Endothelial Dysfunction, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Vasoplegia, Endothelial Dysfunction
- How many people
- 0 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2016to 2 Mar 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients ≥ 18 years, operated on for cardiac surgical myocardial revascularization (CABG) or surgical correction of aortic valve. Consent signed.
Who may be able to join
- Patients ≥ 18 years.
- Patient operated on for cardiac surgical myocardial revascularization (CABG) or surgical correction of aortic valve.
- Consent signed.
Who cannot join
- Standing arrhythmia.
- Pregnant woman.
- curative anticoagulation (warfarin, NANCO, heparin).
- Patient under guardianship.
- Patient Refused to participate.
- Cardiac surgery without CPB.
Show all 10Show fewer
- 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 locations and contacts
1 site in 1 country.
About this study
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
- Medical subject headings
- Vasoplegia
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (6)
Occurrence of vasoplegic syndrome
Occurrence of vasoplegic syndrome correlate with markers of endothelial function following: endothelial microparticles, Von Willebrand factor, VCAM1.
Measured: 6 months
Marker of degradation glycocalyx:
Marker of degradation glycocalyx: syndecan, heparan sulfate.
Measured: 6 months
Inflammatory markers:
Inflammatory markers: leukocytes, CRP, procalcitonin, albumin, TNF alpha, IL-10, IL-6, IL1beta
Measured: 6 months
Markers of blood coagulation
Markers of blood coagulation: Platelet count, PT, APTT, fibrinogen, D dimers, soluble complexes.
Measured: 6 months
Complications
Complications: cardiovascular (vasoplegic syndrome), kidney (KDIGO).
Measured: 6 months
Death
Death
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2016 (estimated)
- Study startNov 2016 (estimated)
- Primary completionSep 2018 (estimated)
- Study completion2 Mar 2020
Why it stopped: Difficult recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VasoplegiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pierre-Grégoire GUINOT, Doctor, Principal investigator, CHU Amiens Picardie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02965339
- Sponsor's protocol ID
- RNI2015-05 (PI2015-05)
- Acronym
- DYVA
- Status last verified
- Jun 2026
- First submitted
- 14 Nov 2016
- Last updated
- 15 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Association Between Pre-existing Endothelial Dysfunction and the Onset of Vasoplegia During Cardiac Surgery With Cardiopulmonary Bypass
- ClinicalTrials.gov ID
- NCT02965339
- Acronym / sponsor ID
- DYVA / RNI2015-05 (PI2015-05)
- Conditions
- Vasoplegia, Endothelial Dysfunction
- Keywords
- Vasoplegia, endothelial dysfunction, extracorporeal circulation, cardiac surgery
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Difficult recruitment
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Study start
- Nov 2016 (estimated)
- Primary completion
- Sep 2018 (estimated)
- Study completion
- 2 Mar 2020 (actual)
- First posted
- 16 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients ≥ 18 years, operated on for cardiac surgical myocardial revascularization (CABG) or surgical correction of aortic valve. Consent signed.
Key inclusion criteria (3 listed)
- Patients ≥ 18 years.
- Patient operated on for cardiac surgical myocardial revascularization (CABG) or surgical correction of aortic valve.
- Consent signed.
Key exclusion criteria (10 listed)
- Standing arrhythmia.
- Pregnant woman.
- curative anticoagulation (warfarin, NANCO, heparin).
- Patient under guardianship.
- Patient Refused to participate.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The primary endpoint was the occurrence of vasoplegic syndrome
Time frame: 6 months
The primary endpoint was the occurrence of vasoplegic syndrome correlate with markers of endothelial function following: IL8, P-selectin, von Willebrand factor precursor.
6 secondary outcomes
Occurrence of vasoplegic syndrome
Time frame: 6 months
Marker of degradation glycocalyx:
Time frame: 6 months
Inflammatory markers:
Time frame: 6 months
Markers of blood coagulation
Time frame: 6 months
Complications
Time frame: 6 months
Death
Time frame: 6 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pierre-Grégoire GUINOT, Doctor principal investigator
CHU Amiens Picardie
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vasoplegia and Endothelial Dysfunction, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 15 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary endpoint was the occurrence of vasoplegic syndrome (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2026.