Intravenous Exenatide in Patients With Acute Brain Injury

Completed · Phase 4

Conditions studied: Brain Injuries

In brief

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

Key facts

Study ID

NCT02058940

Run by

University of North Carolina, Chapel Hill

People needed

8

Starts

2015-08-01

Expected to finish

2017-08-01

Last updated by the study team

2018-07-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of North Carolina; UNC Medical Center — Chapel Hill, North Carolina, United States

Full record on ClinicalTrials.gov

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