Intravenous Exenatide in Patients With Acute Brain Injury

• Status: Completed
• Trial end date: 2017-08-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to assess the feasibility of exenatide infusion for the treatment of high blood sugars following acute brain injury.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of North Carolina, Chapel Hill
• Collaborators: AstraZeneca; Medtronic
• Treatments: Exenatide

Criteria

Inclusion Criteria:

• Adults ≥18 years

• Acute brain injury resulting in admission to the Neurosciences Intensive Care Unit for an anticipated length of stay >48 hours

• Two Blood glucose concentrations > 150 mg/dL and ≤300 mg/dL

• Informed consent obtained via proxy

Exclusion Criteria:

• Pregnant (verified by urine or serum pregnancy test within 24 hours of initiation of infusion) or lactating females

• Type 1 diabetes mellitus

• History of pancreatitis or risk factors for acute pancreatitis (i.e ethanol abuse, gall stones)

• Renal insufficiency defined as creatinine clearance (CrCL) < 45 mL/min

• Known history of gastroparesis

• History of surgery on stomach, esophagus or duodenum

• Diabetic Ketoacidosis or Hyperosmolar Hyperglycemic Nonketotic Syndrome

• Concurrent steroid use or planned post-operative steroid use

• History of organ transplantation

• Brain death or suspected imminent brain death within the next 72 hours

• Refractory intracranial hypertension defined as intracranial pressure (ICP) > 25 mmHg for greater than 15 minutes and refractory to medical intervention

• Currently enrolled in another investigational drug or device protocol

• Insulin infusion within 3 hours of study drug administration or confirmed long acting insulin or sulfonylurea use prior to admission within 24 hours of study drug administration

• Known allergy to exenatide