Status:
UNKNOWN
Perioperative Inflammatory Response Assessment in High-risk Patients Undergoing Noncardiac Surgery
Lead Sponsor:
Medical University of Vienna
Collaborating Sponsors:
Medical University of Graz
Conditions:
Postoperative Complications
Cardiovascular Complication
Eligibility:
All Genders
45+ years
Brief Summary
Postoperative cardiovascular complications are common after noncardiac surgery. The association between perioperative inflammation and the occurrence of cardiovascular complications after surgery is s...
Eligibility Criteria
Inclusion
- All patients need to meet all of the following criteria for inclusion (1-4):
- Surgery planned for more than two hours
- ≥ 45 years of age
- Provide written informed consent AND
- Fulfill ≥ 1 of the following criteria (A-K)
- 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
- 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
Key Trial Info
Start Date :
January 19 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
January 31 2025
Estimated Enrollment :
1400 Patients enrolled
Trial Details
Trial ID
NCT04753307
Start Date
January 19 2021
End Date
January 31 2025
Last Update
August 14 2023
Active Locations (1)
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1
Medical University of Vienna
Vienna, Austria, 1090