GLP-1 Receptor Agonist for Reduction of Myocardial Injury After Non-cardiac Surgery
Glucagon-like Peptide-1 Receptor Agonist for Reduction of Myocardial Injury After Non-Cardiac Surgery
The University of Hong Kong
372 participants
Mar 20, 2024
INTERVENTIONAL
Conditions
Summary
This is an investigator initiated, multi-center, open-labelled, superiority randomized controlled trial of 372 patients undergoing elective non-cardiac surgery. Recruited patients will be randomized in a 2:1 ratio to receive single subcutaneous dose of Glucagon-like Peptide-1 Receptor Agonist (GLP-1 RAs) 1 to 14 days prior to surgery or receive routine care. Dulaglutide (Trulicity; Eli Lilly, USA) is chosen as GLP-1 Receptor Agonists investigational drug for this study. Apart from peri-operative routine care, all recruited subjects will undergo physical, respiratory and cardiac assessments including electrocardiography and blood check including cardiac enzymes. Myocardial injury, cardiovascular outcomes and safety will be assessed and evaluated for efficacy and safety of this prophylactic measurement for the reduction of myocardial injury after non-cardiac surgery.
Eligibility
Inclusion Criteria4
- Age ≥ 18 years
- Planned elective intermediate to high risk non-cardiac surgery under general anesthesia
- Anticipated to remain hospitalized for at least one night after surgery
- Voluntarily agrees to participate by providing written informed consent
Exclusion Criteria13
- History of symptomatic hypoglycemia within 1 month of recruitment
- History of pancreatitis
- Diabetic retinopathy
- Personal or family history of medullary thyroid carcinoma (MTC)
- Multiple Endocrine Neoplasia syndrome type 2 (MEN 2)
- Acute coronary syndrome, decompensated heart failure, cardiogenic shock, or myocarditis within 1 month of recruitment
- Stroke or transient ischemic attack within 1 month of recruitment
- Known severe liver disease (Child-Pugh B or C)
- Stage 5 chronic kidney disease (estimated glomerular filtration rate (eGFR) by Modified Diet in Renal Disease (MDRD) equation \< 15 mL/min)
- Recent use of GLP-1 RA within 1 month of recruitment
- Known allergy or hypersensitivity to GLP-1 RA
- Women of childbearing age who are not taking effective contraception, or who are pregnant or breast-feeding
- Use of Dipeptidyl peptidase-4 inhibitor(DPP4i)
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Interventions
Subject randomized into treatment group will receive single subcutaneous dose of Dulaglutide 0.75mg 1 to 14 days prior to surgery
Locations(3)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06324461