Perioperative Inflammatory Response Assessment in High-risk Patients Undergoing Noncardiac Surgery (INSIGHT)

Medical University of Vienna

Status: Enrolling

Conditions: Postoperative Complications; Inflammation; Myocardial Ischemia; Cardiovascular Complication

Treatments: Diagnostic Test: Laboratory measurements

Study type: Observational

Funder types: Other

Identifiers

NCT04753307

INSIGHT

Details and patient eligibility

About

Postoperative cardiovascular complications are common after noncardiac surgery. The association between perioperative inflammation and the occurrence of cardiovascular complications after surgery is still unknown. Therefore, we will evaluate as our primary aim the association between patients with increased postoperative inflammation, assessed with C-reactive protein measurements, and the occurrence of major cardiovascular complications after noncardiac surgery. We will further evaluate the influence of perioperative inflammation on the occurrence of postoperative acute kidney injury. We will also evaluate the association between inflammation and the influence on Days-At-Home within 30 days. Furthermore, we will evaluate the association between increased inflammatory biomarkers and postoperative N-terminal pro brain natriuretic peptide (NT-proBNP) concentration.

Enrollment: 1,400 estimated patients

Sex: All

Ages: 45+ years old

Volunteers: No Healthy Volunteers

Inclusion and 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

Trial design

1,400 participants in 1 patient group

Patients at least 45 years at-risk for cardiovascular complications

Treatment:

Diagnostic Test: Laboratory measurements