Cardiac Surgical ProceduresVaso-shockNCT06318689
In Situ Exploration of Vascular Function in Vasoplegic Shock Following Cardiac Surgery With Cardiopulmonary Bypass
An observational study of Cardiac Surgical Procedures, run by University Hospital, Rouen at 1 site in France.
Trial summary
The goal of this observational study is to assess in situ vascular function, glycocalyx and microcirculation in postoperative vasoplegic shock following cardiac surgery with cardiopulmonary bypass. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Cardiac Surgical Procedures
- How many people
- 124 participants
- Where
- 1 siteFrance
- Study dates
- 5 Feb 2024to 5 May 2026
- How long will I take part?
- 24 Months
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients aged between 18 and 80 years old hospitalised in the cardiac intensive care unit after cardiac surgery requiring cardiopulmonary bypass.
Who may be able to join
- Patients aged between 18 and 80 years old
- Patient undergoing cardiac surgery with cardiopulmonary bypass
- Hospitalised in a cardiac surgical unit, between 4 and 24 hours after the end of cardiopulmonary bypass, after volemic optimisation
Who cannot join
- Sepsis at inclusion
- Cardiac transplant
- Circulatory assistance
- Known alteration of the microcirculation
- Any condition contraindicating measurement via Glycocheck or flux mediated dilatation measurement
- New surgery within 48 hours of the operation
- Person deprived of liberty by an administrative or judicial decision or person placed under legal protection / sub-guardianship or guardianship
- Patient refusal
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Rouen University Hospital
Rouen, Normandy, 76000
Emmanuel Besnier, MD, PhD, 33232881705, emmanuel.besnier@chu-rouen.fr
Domitille Renard, MD, 33232881705, domitille.renard@chu-rouen.fr
About this study
The goal of this observational study is to assess in situ vascular function, glycocalyx and microcirculation in postoperative vasoplegic shock following cardiac surgery with cardiopulmonary bypass.
The main question is to investigate the relationship between NO-dependent vasomotor reserve and the presence of vasoplegic shock following cardiac surgery with cardiopulmonary bypass.
Read more
Participants will have two visits, during which a number of non-invasive examinations will be carried out to study glycocalyx, microcirculation and vascular function. Biological and morphological data will be collected up to 3 months after inclusion, as well as information on treatments administered and outcome.
Researchers will compare a group of patients with vasoplegic shock against a group without vasoplegic shock in order to study possible alterations in function in the vasoplegic shock group.
Read the detailed description
Objective : the primary objective of this study is to explore in situ the glycocalyx, the microcirculation and vascular function in postoperative vasoplegic shock following cardiac surgery with CPB. Secondary objectives are to study links between vascular function and damage to the glycocalyx and microcirculation and patient prognosis, in particular their impact on fluid balance.
Method :
Constitution of a single-centre prospective cohort study of 124 patients. Patients hospitalised in the cardiac intensive care unit after cardiac surgery with CPB will be consecutively included from 4 to 24 hours after surgery: 62 patients with vasoplegic shock (noradrenaline > 0.05µg/kg/min for at least 4 hours and after correction of any hypovolaemia), 62 patients without vasoplegic shock.
Endothelial function will be assessed using the flow-mediated dilation (FMD) method to test brachial artery vasodilation mediated by nitric oxide (NO) after induced ischemia. Microcirculation and glycocalyx will be evaluated using GlycoCheck, providing several measurements of microcirculation and glycocalyx using Sidestream Dark Field technology (mucosal illumination by a green LED and continuous x20 magnification video recording at the sublingual mucosa level). Various endothelial and inflammatory markers will also be measured (VCAM-1, syndecan, endothelin, interleukin-6).
Each patient will be assessed at inclusion and 48 hours using GlycoCheck, FMD, and endothelial measurements, then followed through their medical records for 90 days, where a follow-up call will be conducted to assess outcomes. Collected information will include routine care data (morphological data, vital signs, laboratory tests, fluid balance, scores, treatments, surgical data).
Both groups will be compared using statistical tests, and risk factors for developing vasoplegic shock will be explored through logistic regression. Univariable analysis followed by multivariable logistic regression with backward data inclusion will then be performed to identify risk factors for vasoplegic syndrome within the entire cohort (necessarily including FMD and GlycoCheck). A p-value <0.05 will be considered statistically significant.
- Conditions
- Cardiac Surgical Procedures
- Keywords
- Cardiopulmonary Bypass, Vasoplegia, Glycocalyx, Vascular function
- Medical subject headings
- Vasoplegia
What is being measured
The primary outcome is the main question the study is designed to answer.
Association between the percentage of brachial artery variation measured by the flow-mediated vasodilation method and the presence of vasoplegic shock at incusion.
Association between the percentage of brachial artery variation measured by the flow-mediated vasodilation method and the presence of vasoplegic shock.
Measured: At inclusion
Secondary outcomes (10)
Association between the percentage of brachial artery variation measured by the flow-mediated vasodilation method and the presence of vasoplegic shock at 48 hours.
Association between the percentage of brachial artery variation measured by the flow-mediated vasodilation method and the presence of vasoplegic shock.
Measured: At 48 hours
Pefused boundary region (PBR, µm) obtained from Glycocheck with the presence of vasoplegic shock.
Pefused boundary region is an index given by the Glycocheck, a reflection of the alteration of the glycocalyx.
The higher the value, the more impaired the glycocayx.
Measured: At inclusion and at 48 hours
Microvascular blood flow (10^3 microns^3 / sec / mm^2) obtained from Glycocheck with the presence of vasoplegic shock
Microvascular blood flow (10^3 microns^3 / sec / mm^2), given by the Glycocheck, is an estimation of the microcirculation. The lower the value, the more it indicates a deterioration in microcirculation.
Measured: At inclusion and at 48 hours
Total density (number of 10 micron long vessel segments with diameter of 4 to 25 microns per tissue surface area /mm^2) obtained from Glycocheck with the presence of vasoplegic shock
Total density (number of 10 micron long vessel segments with diameter of 4 to 25 microns per tissue surface area /mm^2), given by the Glycocheck, is an estimation of the density ot the vessels. The lower the value, the more it indicates a deterioration in microcirculation.
Measured: At inclusion and at 48 hours
Endothelial function markers (Endothelin-1, pg/mL) with the presence of vasoplegic shock
Endothelin-1 (pg/ml), indicates vasoconstriction, will be measured by ELISA.
Measured: At inclusion and at 48 hours
Endothelial function markers (syndecan-1, pg/mL) with the presence of vasoplegic shock
Endothelin-1 (pg/ml), indicates endothelium ateration, will be measured by ELISA.
Measured: At inclusion and at 48 hours
Endothelial function markers (interleukin-6, pg/mL) with the presence of vasoplegic shock
Interleukin-6 (pg/ml), indicates inflammation, will be measured by ELISA.
Measured: At inclusion and at 48 hours
Endothelial function markers (VCAM-1, pg/mL) with the presence of vasoplegic shock
VCAM-1 (pg/ml), indicates endothelium ateration, will be measured by ELISA.
Measured: At inclusion and at 48 hours
Multivariate analysis explaining the occurrence of vasoplegic shock.
Model constructed from variables found to be associated in univariate analysis.
Measured: At inclusion and at 48 hours
Multivariate analysis explaining the occurrence of an altered perfused boundary region (µm).
Model constructed from variables found to be associated in univariate analysis.
Measured: At inclusion and at 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2024
- Study start5 Feb 2024
- Primary completion5 Feb 2026 (estimated)
- Study completion5 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiac Surgical ProceduresStudies of the same condition, open and under way.
- More trials run by University Hospital, RouenThe sponsor's other registered studies.
- 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
- 124 participants (estimated)
- Target duration
- 24 Months
Sponsor and investigators
- Lead sponsor
- University Hospital, Rouen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Emmanuel EB BESNIER, PHD, Principal investigator, CHU Rouen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06318689
- Sponsor's protocol ID
- 2023/0211/OB
- Acronym
- Vaso-shock
- Status last verified
- Feb 2024
- First submitted
- 23 Feb 2024
- Last updated
- 19 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Ferry N, Renard D, Gillibert A, Clavier T, Tamion F, Abedi A, Selim J, Bellien J, Besnier E. In situ exploration of endothelial function in vasoplegic syndrome after cardiac surgery with cardiopulmonary bypass: protocol for a single-centre prospective cohort study - the Vasoshock study. BMJ Open. 2026 Sep 18;16(9):e122692. doi: 10.1136/bmjopen-2026-122692.
PubMed 42760087
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- In Situ Exploration of Vascular Function in Vasoplegic Shock Following Cardiac Surgery With Cardiopulmonary Bypass
- ClinicalTrials.gov ID
- NCT06318689
- Acronym / sponsor ID
- Vaso-shock / 2023/0211/OB
- Conditions
- Cardiac Surgical Procedures
- Keywords
- Cardiopulmonary Bypass, Vasoplegia, Glycocalyx, Vascular function
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 124 participants (estimated)
- Lead sponsor
- University Hospital, RouenUniversity, hospital or other
- Study start
- 5 Feb 2024 (actual)
- Primary completion
- 5 Feb 2026 (estimated)
- Study completion
- 5 May 2026 (estimated)
- First posted
- 19 Mar 2024 (actual)
- 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.
The goal of this observational study is to assess in situ vascular function, glycocalyx and microcirculation in postoperative vasoplegic shock following cardiac surgery with cardiopulmonary bypass.
The main question is to investigate the relationship between NO-dependent vasomotor reserve and the presence of vasoplegic shock following cardiac surgery with cardiopulmonary bypass.
Participants will have two visits, during which a number of non-invasive examinations will be carried out to study glycocalyx, microcirculation and vascular function. Biological and morphological data will be collected up to 3 months after inclusion, as well as information on treatments administered and outcome.
Researchers will compare a group of patients with vasoplegic shock against a group without vasoplegic shock in order to study possible alterations in function in the vasoplegic shock group.
Detailed description
Objective : the primary objective of this study is to explore in situ the glycocalyx, the microcirculation and vascular function in postoperative vasoplegic shock following cardiac surgery with CPB. Secondary objectives are to study links between vascular function and damage to the glycocalyx and microcirculation and patient prognosis, in particular their impact on fluid balance.
Method :
Constitution of a single-centre prospective cohort study of 124 patients. Patients hospitalised in the cardiac intensive care unit after cardiac surgery with CPB will be consecutively included from 4 to 24 hours after surgery: 62 patients with vasoplegic shock (noradrenaline > 0.05µg/kg/min for at least 4 hours and after correction of any hypovolaemia), 62 patients without vasoplegic shock.
Endothelial function will be assessed using the flow-mediated dilation (FMD) method to test brachial artery vasodilation mediated by nitric oxide (NO) after induced ischemia. Microcirculation and glycocalyx will be evaluated using GlycoCheck, providing several measurements of microcirculation and glycocalyx using Sidestream Dark Field technology (mucosal illumination by a green LED and continuous x20 magnification video recording at the sublingual mucosa level). Various endothelial and inflammatory markers will also be measured (VCAM-1, syndecan, endothelin, interleukin-6).
Each patient will be assessed at inclusion and 48 hours using GlycoCheck, FMD, and endothelial measurements, then followed through their medical records for 90 days, where a follow-up call will be conducted to assess outcomes. Collected information will include routine care data (morphological data, vital signs, laboratory tests, fluid balance, scores, treatments, surgical data).
Both groups will be compared using statistical tests, and risk factors for developing vasoplegic shock will be explored through logistic regression. Univariable analysis followed by multivariable logistic regression with backward data inclusion will then be performed to identify risk factors for vasoplegic syndrome within the entire cohort (necessarily including FMD and GlycoCheck). A p-value <0.05 will be considered statistically significant.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 24 Months
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients aged between 18 and 80 years old hospitalised in the cardiac intensive care unit after cardiac surgery requiring cardiopulmonary bypass.
Key inclusion criteria (3 listed)
- Patients aged between 18 and 80 years old
- Patient undergoing cardiac surgery with cardiopulmonary bypass
- Hospitalised in a cardiac surgical unit, between 4 and 24 hours after the end of cardiopulmonary bypass, after volemic optimisation
Key exclusion criteria (8 listed)
- Sepsis at inclusion
- Cardiac transplant
- Circulatory assistance
- Known alteration of the microcirculation
- Any condition contraindicating measurement via Glycocheck or flux mediated dilatation measurement
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
Association between the percentage of brachial artery variation measured by the flow-mediated vasodilation method and the presence of vasoplegic shock at incusion.
Time frame: At inclusion
Association between the percentage of brachial artery variation measured by the flow-mediated vasodilation method and the presence of vasoplegic shock.
10 secondary outcomes
Association between the percentage of brachial artery variation measured by the flow-mediated vasodilation method and the presence of vasoplegic shock at 48 hours.
Time frame: At 48 hours
Pefused boundary region (PBR, µm) obtained from Glycocheck with the presence of vasoplegic shock.
Time frame: At inclusion and at 48 hours
Microvascular blood flow (10^3 microns^3 / sec / mm^2) obtained from Glycocheck with the presence of vasoplegic shock
Time frame: At inclusion and at 48 hours
Total density (number of 10 micron long vessel segments with diameter of 4 to 25 microns per tissue surface area /mm^2) obtained from Glycocheck with the presence of vasoplegic shock
Time frame: At inclusion and at 48 hours
Endothelial function markers (Endothelin-1, pg/mL) with the presence of vasoplegic shock
Time frame: At inclusion and at 48 hours
Endothelial function markers (syndecan-1, pg/mL) with the presence of vasoplegic shock
Time frame: At inclusion and at 48 hours
Endothelial function markers (interleukin-6, pg/mL) with the presence of vasoplegic shock
Time frame: At inclusion and at 48 hours
Endothelial function markers (VCAM-1, pg/mL) with the presence of vasoplegic shock
Time frame: At inclusion and at 48 hours
Multivariate analysis explaining the occurrence of vasoplegic shock.
Time frame: At inclusion and at 48 hours
Multivariate analysis explaining the occurrence of an altered perfused boundary region (µm).
Time frame: At inclusion and at 48 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2024.
- Derived from this study: PubMed 42760087Ferry N, Renard D, Gillibert A, Clavier T, Tamion F, Abedi A, Selim J, Bellien J, Besnier E. In situ exploration of endothelial function in vasoplegic syndrome after cardiac surgery with cardiopulmonary bypass: protocol for a single-centre prospective cohort study - the Vasoshock study. BMJ Open. 2026 Sep 18;16(9):e122692. doi: 10.1136/bmjopen-2026-122692.
- Individual participant dataSharing planned: Undecided
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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.
Emmanuel EB BESNIER, PHD principal investigator
CHU Rouen
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 Cardiac Surgical Procedures, run by University Hospital, Rouen 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 8 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: status not confirmed, as of the sponsor's last update on 19 Mar 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Emmanuel EB BESNIER, PHD (02 32 88 89 90, emmanuel.besnier@chu-rouen.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Association between the percentage of brachial artery variation measured by the flow-mediated vasodilation method and the presence of vasoplegic shock at incusion. (time frame: At inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06318689, which also lists 1 linked publication.
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 19 Mar 2024.