Intravenous Exenatide in Patients With Acute Brain Injury



Status:Completed
Conditions:Hospital, Neurology, Neurology
Therapuetic Areas:Neurology, Other
Healthy:No
Age Range:18 - Any
Updated:7/14/2018
Start Date:August 2015
End Date:August 2017

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Intravenous Exenatide Infusion in Critically Ill Patients With Acute Brain Injury

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


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
We found this trial at
1
site
Chapel Hill, North Carolina 27599
Principal Investigator: Nicole R. Pinelli, PharmD
Phone: 919-962-1641
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mi
from
Chapel Hill, NC
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