Exploring Vascular Function in Patients with Vasoplegic Shock After Heart Surgery
In Situ Exploration of Vascular Function in Vasoplegic Shock Following Cardiac Surgery With Cardiopulmonary Bypass
This study looks at how blood vessels work in patients who have low blood pressure after heart surgery to see if it affects their recovery and overall health.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 124 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | University Hospital, Rouen Academic / other |
| Locations | 1 site (Rouen, Normandie) |
| Trial ID | NCT06318689 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess vascular function, glycocalyx, and microcirculation in patients experiencing vasoplegic shock following cardiac surgery with cardiopulmonary bypass. Participants will undergo non-invasive examinations to evaluate these parameters, with data collected up to three months post-surgery. The study will compare patients with vasoplegic shock to those without, focusing on the relationship between nitric oxide-dependent vasomotor reserve and vascular function. The research will also investigate how these factors relate to patient prognosis and fluid balance.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 80 who have undergone cardiac surgery with cardiopulmonary bypass and are hospitalized in a cardiac surgical unit within 4 to 24 hours post-surgery.
Not a fit: Patients with sepsis, cardiac transplant, or known alterations of microcirculation are unlikely to benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved understanding and management of vascular function in patients experiencing vasoplegic shock, potentially enhancing recovery outcomes.
How similar studies have performed: While this approach is focused on a specific patient population, similar studies assessing vascular function and microcirculation have shown promising results, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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
Where this trial is running
Rouen, Normandie
- Rouen University Hospital — Rouen, Normandie, France (Recruiting)
Study contacts
- Principal investigator: Emmanuel EB BESNIER, PHD — CHU Rouen
- Study coordinator: Emmanuel EB BESNIER, PHD
- Email: emmanuel.besnier@chu-rouen.fr
- Phone: 02 32 88 89 90
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.