Intravenous Exenatide in Patients With Acute Brain Injury

Phase 4CompletedNCT02058940

University of North Carolina, Chapel Hill8 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Brain Injuries

Interventions

ExenatideDRUG

50 ng/min IV for 30 minutes, then start 25 ng/min IV for a maximum duration of 48 hours

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

University of North Carolina; UNC Medical Center

Chapel Hill, North Carolina, United States

Outcomes

Primary Outcomes

Percentage of Critically Ill Patients With Acute Brain Injury Achieving Pre-specified Feasibility Criteria

Feasibility is defined as the percentage of patients 1) experiencing severe hypoglycemia (\<40 mg/dL); 2) achieving glucose measurements within goal (110-180 mg/dL); and 3) experiencing nausea requiring discontinuation of exenatide therapy. The pre-specified criteria for determining feasibility includes the following: 1) at least 75% of patients achieving glucose measurements within goal (110-180 mg/dL) and 2) no more than 25% of patients experiencing severe hypoglycemia (\<40 mg/dL) or nausea requiring exenatide discontinuation.