Investigating the effects of endotoxins on blood pressure after heart surgery
Effect of Endotoxinemia on the Incidence of Postoperative Vasoplegia or Vasoplegic Shock Following Cardiothoracic Surgery Using Cardiopulmonary Bypass
This study is trying to see how high levels of certain toxins in the blood after heart surgery affect blood pressure and complications like vasoplegia in patients.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Universität Münster Academic / other |
| Locations | 1 site (Münster) |
| Trial ID | NCT05925348 on ClinicalTrials.gov |
What this trial studies
This observational study examines how endotoxinemia affects the occurrence of vasoplegia and vasoplegic shock in patients undergoing cardiac surgery with cardiopulmonary bypass (CPB). It focuses on the systemic inflammatory response triggered by CPB, which can lead to significant complications post-surgery. The study aims to clarify the relationship between endotoxin levels in the bloodstream and the incidence of these complications, building on previous but inconclusive research. By analyzing blood samples from patients, the study seeks to provide insights into the mechanisms behind postoperative vasoplegia.
Who should consider this trial
Good fit: Ideal candidates include adult patients scheduled for cardiac surgery that requires cardiopulmonary bypass.
Not a fit: Patients undergoing emergency surgery for acute coronary syndrome or those with chronic inflammatory diseases of the gut may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved management strategies for preventing vasoplegia in patients undergoing cardiac surgery.
How similar studies have performed: Previous studies have suggested a link between endotoxin release and postoperative complications, but this study aims to provide more definitive evidence in a larger cohort.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. adult patients undergoing cardiac surgery requiring CPB 2. written informed consent Exclusion Criteria: 1. emergency surgery in the context of acute coronary syndrome 2. patients with chronic inflammatory diseases of the gut 3. patients receiving immunosuppressive drugs 4. patients with infectious endocarditis 5. patients with sepsis 6. patients with chronic kidney disease with estimated glomerular filtration rate (eGFR) \<20 ml/min/1,73m² 7. persons with any kind of dependency on the investigator or employed by the institution responsible or investigator 8. persons held in an institution by legal of official order -
Where this trial is running
Münster
- University Hospital Münster — Münster, Germany (Recruiting)
Study contacts
- Study coordinator: Sadjadi, MD
- Email: aki@anit.uni-muenster.de
- Phone: +49-251-8347255
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.