Hyperglycemia, Hypoglycemia
Conditions
Keywords
Cardiac, Surgery, Glycemia
Brief summary
This is a medical research study designed to see if an infusion of a naturally occurring hormone, GLP-1, works when used to decrease blood sugar during cardiac surgery.
Interventions
BIOLOGICALGLP 1
This a continuous intravenous infusion of GLP-1 (7-36) amide infusion (1.5 pmol/kg/min)
BIOLOGICALnormal saline solution placebo
This is a continuous intravenous infusion of normal saline solution as placebo (1.5 pmol/kg/min) during cardiac surgery
Sponsors
University of Pennsylvania
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. male or female age (18-80 years), 2. ability to provide informed consent, 3. elective CABG with or without single or multivalve repair or replacement, and/ or 4. single or multivalve repair or replacement requiring CPB and sternotomy (to include subjects who are undergoing first time or redo cardiac surgery).
Exclusion criteria
1. concomitant surgery (e.g. carotid endarterectomy), 2. emergent surgery, 3. current steroid use, 4. insulin dependent diabetes mellitus (IDDM), 5. cardiac surgery without the use of cardiopulmonary bypass (e.g. off-pump CABG), 6. current use of positive intravenous inotropic agents, 7. serious intercurrent illness (endocarditis, sepsis, active malignancy requiring treatment) or active infection, 8. known substance abuse, 9. receipt of an investigational drug or device within 30 days prior to surgery, 10. known allergy to any of the following: GLP-1, fentanyl, midazolam, isoflurane, propofol, morphine, heparin or protamine, 11. Sulfonylurea medication administration on morning of surgery (such as, tolbutamide, tolazamide (Tolinase), chlorpropamide (Diabinese). glipizide (Glucotrol, Glucotrol XL), glyburide (Micronase, Glynase PresTabs, and DiaBeta), glimepiride (Amaryl), 12. Major end organ dysfunction defined as: 1. Cardiac: Left ventricular ejection fraction (LVEF) \< 30% by left ventriculography or echocardiogram (within 90 days prior to randomization), current use of positive intravenous inotropic agents, preoperative use of intra-aortic balloon pump (IABP), left ventricular assist device (LVAD), or extracorporeal membrane oxygenation (ECMO); 2. Renal: preoperative serum Creatinine \> 2.0 mg/dL; 3. Hepatic: aspartate aminotransferase (AST) or alanine transferase (ALT) \> 2.5 x upper limit normal; 4. Hematologic: preoperative hematocrit (HCT) \< 30%, platelet count \< 100,000/mm3, history of (or family history of) bleeding or clotting disorder; 13. Patients with a history of or risk factors for acute pancreatitis (i.e. ethanol abuse, gall stones) will be excluded from this study, 14. Pregnant or breastfeeding females, or 15. any other condition that, in the opinion of the investigator, may compromise the safety of the subject or would preclude the subject from successful completion of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome variables are plasma GLP-1 levels and plasma Glucose levels. | During surgery and 24 hours after |
Countries
United States
Outcome results
None listed