Study of alternative drug to insulin for the treatment of high blood glucose concentration in cardiac surgery patients

GLP-1 for bridging of hyperglycaemia during cardiac surgery: a randomized controlled trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON29585

Enrollment

274

Registered

2017-01-04

Start date

2017-06-09

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus Hyperglycaemia Cardiac Surgery

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 b

Eligibility

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 Neoplasia23 syndrome type 2 (MEN2) • Heart failure NYHA class III or IV • Serum-creatinine ≥ 133 μmol l-1 for males and ≥ 115 μmol 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 outcome measure is the proportion of patients needing insulin therapy in the perioperative period (morning of surgery until transfer to the Intensive Care Unit)	—

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 perioperative of hypoglycaemic events (<4 mmol l-1) • Number of severe hypoglycaemic events (<2.3 mmol l-1) • Proportion of patients with postoperative nausea and vomiting	—

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 perioperative of hypoglycaemic events (<4 mmol l-1) • Number of severe hypoglycaemic events (<2.3 mmol l-1) • Proportion of patients with postoperative nausea and vomiting

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Contacts

Public ContactA.H. Hulst

Academisch Medisch Centrum Postbus 22660

a.h.hulst@amc.uva.nl0615222469

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)