Investigating hormone differences in cardiac surgery patients
Differences in Plasma Concentration of RAAS-axis Hormones in Patients Undergoing Cardiac Surgery With or Without Cardiopulmonary Bypass
Universität Münster · NCT05833828
This study looks at hormone levels in patients having different types of heart surgery to see how these levels might affect complications like low blood pressure during the procedure.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Universität Münster (other) |
| Locations | 2 sites (Berlin and 1 other locations) |
| Trial ID | NCT05833828 on ClinicalTrials.gov |
What this trial studies
This observational study examines the differences in plasma hormone concentrations of the renin-angiotensin-aldosterone system (RAAS) between patients undergoing on-pump versus off-pump cardiac surgery. It aims to understand how cardiopulmonary bypass may influence the incidence of vasoplegia or vasoplegic shock, a serious complication during cardiac procedures. By analyzing hormone levels, the study seeks to clarify the role of pulmonary circulation in regulating vascular tension and blood pressure during surgery.
Who should consider this trial
Good fit: Ideal candidates include adult patients scheduled for on- or off-pump coronary artery bypass graft surgery.
Not a fit: Patients undergoing emergency surgery for acute coronary syndrome or those with severe lung disease 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 cardiac surgery patients.
How similar studies have performed: While the specific approach of this study is novel, previous studies have indicated the importance of RAAS in cardiovascular complications, suggesting potential for meaningful insights.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. adult patients undergoing on- or off-pump coronary artery bypass graft surgery 2. written informed consent Exclusion Criteria: 1. emergency surgery in the context of acute coronary syndrome 2. ACE-inhibitor or Angiotensin 1 (AT1)-receptor-blocker intake that was not paused on the day of surgery 3. Chronic kidney disease with estimated glomerular filtration rate (eGFR)\<30ml/min/1.73m² 4. Severe structural lung disease (asbestosis, silicosis, severe sarcoidosis, tuberculosis, severe emphysema, chronic obstructive pulmonary disease (COPD) Gold 3-4, lung fibrosis) 5. Chronic pulmonary hypertension 6. Pregnancy or breastfeeding 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 or official order
Where this trial is running
Berlin and 1 other locations
- Deutsches Herzzentrum der Charité — Berlin, Germany (RECRUITING)
- University Hospital Münster; Department of Anesthesiology, Intensive Care Medicine and Pain Medicine — Münster, Germany (RECRUITING)
Study contacts
- Study coordinator: Alexander Zarbock, MD
- Email: aki@anit.uni-muenster.de
- Phone: +492518347255
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.
Conditions: Vasoplegia, Vasoplegic Shock, vasoplegia, vasoplegic shock, cardiopulmonary bypass, cardiac surgery