Assessing inflammation in high-risk patients undergoing noncardiac surgery
Perioperative Inflammatory Response Assessment in High-risk Patients Undergoing Noncardiac Surgery - a Prospective Non-interventional Observational Study
Medical University of Vienna · NCT04753307
This study is testing how inflammation during and after surgery affects heart problems and recovery in patients who are at high risk for complications.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1400 (estimated) |
| Ages | 45 Years and up |
| Sex | All |
| Sponsor | Medical University of Vienna (other) |
| Locations | 1 site (Vienna) |
| Trial ID | NCT04753307 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the relationship between perioperative inflammation and the occurrence of cardiovascular complications in high-risk patients undergoing noncardiac surgery. It will primarily assess postoperative inflammation through C-reactive protein measurements and its association with major cardiovascular complications, acute kidney injury, and overall recovery as measured by Days-At-Home within 30 days. The study will also investigate the correlation between inflammatory biomarkers and NT-proBNP levels post-surgery.
Who should consider this trial
Good fit: Ideal candidates include patients aged 45 and older who are undergoing noncardiac surgery lasting more than two hours and have at least one cardiovascular risk factor.
Not a fit: Patients on immune-suppressive therapy or those with severe heart failure may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved risk assessment and management strategies for high-risk surgical patients, potentially reducing postoperative complications.
How similar studies have performed: Other studies have explored the role of inflammation in postoperative outcomes, suggesting potential for success in this area, though this specific approach may be novel.
Eligibility criteria
Show full inclusion / exclusion criteria
All patients need to meet all of the following criteria for inclusion (1-4): 1. Surgery planned for more than two hours 2. ≥ 45 years of age 3. Provide written informed consent AND 4. Fulfill ≥ 1 of the following criteria (A-K) Inclusion Criteria: * NT-proBNP ≥ 200 ng/L * Troponin T \> 25 ng/L * History of coronary artery disease * History of peripheral artery disease (PAD) * 75 years or older * History of transient ischemic attack (TIA) or stroke * Current smoking or cessation of smoking within 2 years * Diabetes or currently taking anti-diabetic drug * Hyperlipidemia * History of hypertension or currently taking an antihypertensive drug * Atrial fibrillation Exclusion Criteria: * Patients on immune-suppressive therapy * ICU patients undergoing surgery * Preoperative Sepsis/systemic inflammatory syndrome (SIRS) needing ICU treatment * Preoperative hemodynamically instable patients, who require vasopressor or inotropic support * History of severe heart failure (defined as left ventricular ejection fraction (LVEF) \< 30%) * Liver cirrhosis * Chronic inflammatory bowel diseases (CIBD) * Severe rheumatic diseases requiring immunosuppressive treatment
Where this trial is running
Vienna
- Medical University of Vienna — Vienna, Austria (RECRUITING)
Study contacts
- Study coordinator: Christian Reiterer, MD
- Email: christian.reiterer@meduniwien.ac.at
- Phone: 004340400
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: Postoperative Complications, Cardiovascular Complication, Myocardial Ischemia, Inflammation