high blood glucose concentration
Conditions
Interventions
Patients will be randomized (1:1) to perioperative liraglutide treatment or
placebo. Liraglutide or placebo 0.6 mg subcutaneously (sc) the day before
surgery and 1.2 mg sc on the day of surgery will
Cardiac Surgery
GLP-1
Hyperglycaemia
Insulin
Sponsors
Academisch Medisch Centrum
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: * Adult patients, aged 18-80 years (inclusive), * No known diabetes mellitus, or * Known diabetes mellitus type 2 on oral glucose lowering medication, diet or total daily insulin dose *0.5 IU/kg * Scheduled for an elective cardiac surgical procedure. * Informed consent obtained before any trial-related activities are carried out.
Exclusion criteria
Exclusion criteria: * Diabetes mellitus type 1 * Emergency surgery * Receiving oral corticosteroid therapy * History of pancreatic surgery or acute or chronic pancreatitis * Personal or family history of medullary thyroid cancer (MTC) or Multiple Endocrine Neoplasia syndrome type 2 (MEN2) * Heart failure NYHA class IV * Serum-creatinine * 133 *mol l-1 for males and * 115 *mol l-1 for females * Female of child-bearing potential who is pregnant, breast-feeding or intend to become pregnant or is not using adequate contraceptive methods * Current treatment with GLP-1 analogues * Known or suspected allergy to trial products or other drugs in the same class
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The main study endpoint is reduction in the number of patients needing perioperative insulin treatment when aiming for plasma glucose | — |
Secondary
| Measure | Time frame |
|---|---|
| We will assess the following secondary outcome parameters: * Total perioperative insulin use (IU/day) * Number of insulin administrations * Composite postoperative complications* * Glucose control in the perioperative period, as assessed by the mean perioperative glucose * Number of perioperative hyperglycaemic events (>11 mmol l-1) * Number of moderate perioperative hypoglycaemic events ( | — |
Countries
The Netherlands
Outcome results
None listed