The effects of glucagon-like peptide-1 on glycaemia in the critically ill.

Phase 2

Recruiting

• Conditions: Critical illness; Stress-induced hyperglycaemia; Metabolic and Endocrine - Other endocrine disorders

• Registration Number: ACTRN12622001409763
• Lead Sponsor: Royal Adelaide Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-11-04
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

All mechanically ventilated critically ill patients admitted to the Royal Adelaide Hospital Intensive Care Unit are eligible if:
•Aged equal to or between 18 and 80 years old
•Stress hyperglycaemia with a blood glucose of greater than or equal to 11.1 mmol/L
•About to commence or commenced intravenous insulin
•Expected to be in ICU until the end of the next calendar day

Exclusion Criteria

•History of type 1 or type 2 diabetes mellitus
•Glycated haemoglobin (HbA1c) is greater than or equal to 6.5%
•Contraindication to enteral nutrition
•Expected to be eating orally before the end of the next calendar day
•Pregnancy (a ßHCG will be performed on all women of child-bearing age)
•Haemoglobin is less than 80 g/L
•Patients with traumatic brain injury (albumin contraindicated)
•Previous surgery on the oesophagus, stomach or small intestine
•History of pancreatitis
•Death during ICU is deemed inevitable

Withdrawal criteria is classified as:
•BGL is greater than 12 mmol/L for more than 10 hours despite maximal insulin or GLP-1 therapy.
•BGL is greater than 16 mmol/L after 6 hours of study commencement (i.e. T is greater than 6 hours)
•BGL is greater than 20 mmol/L at any time point
•BGL is less than 2.2 mmol/L at any point.
•Two or more episodes of vomiting or overt regurgitation within a 12-hour period.
•Next of kin may withdraw consent at any time.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The total time outside target glucose range (4 - 9.9 mmol/L) represented as the percentage of time for all patients in each study arm (intravenous GLP-1 and insulin infusions) recorded using continuous subcutaneous glucose monitoring data.[ During study infusion (0-48 hours)]