Clinical trial NCT02058940: Intravenous Exenatide in Patients With Acute Brain Injury
Official title: Intravenous Exenatide Infusion in Critically Ill Patients With Acute Brain Injury
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Brain Injuries
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: AstraZeneca
name: Medtronic
First posted: 2014-02-10
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


Eligibility 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

Primary outcomes:
measure: Percentage of Critically Ill Patients With Acute Brain Injury Achieving Pre-specified Feasibility Criteria
timeFrame: Over 48 hours from infusion initiation
Secondary outcomes:
measure: Median Glucose Concentration During Exenatide Infusion
timeFrame: Over 48 hours from infusion initiation
measure: Percentage of Glucose Measurements Within Goal Range
timeFrame: Over 48 hours from infusion initiation
measure: Median Time to Reach Glucose Measurements Within Goal Range (110-180 mg/dL)
timeFrame: Over 48 hours from infusion initiation
measure: Glycemic Variability
timeFrame: Over 48 hours from infusion initiation
measure: Median Insulin Use
timeFrame: Over 48 hours from infusion initiation
measure: Percentage of Patients Requiring Rescue Insulin Infusion Protocol
timeFrame: Over 48 hours from infusion initiation
measure: Percentage of Hypoglycemic Episodes (<80 mg/dL)
timeFrame: Over 48 hours from infusion initiation
measure: Percentage of Patients With >1 Episode of Hypoglycemia (<80 mg/dL)
timeFrame: Over 48 hours from infusion initiation
measure: Percentage of Patients Experiencing Metabolic Crisis
timeFrame: Over 48 hours from infusion initiation
measure: Median Daily Intracranial Pressure
timeFrame: Over 48 hours from infusion initiation
measure: Median Daily Cerebral Perfusion Pressure
timeFrame: Over 48 hours from infusion initiation
measure: Percentage of Hypotensive Episodes (SBP<100 mmHg)
timeFrame: Over 48 hours from infusion initiation
measure: Percentage of Patients With >1 Episode of Hypotensive Episode (SBP<100 mmHg)
timeFrame: Over 48 hours from infusion initiation
measure: Correlation of Exenatide Concentrations With Creatinine Clearance
timeFrame: Over 48 hours from infusion initiation
measure: Exenatide Elimination Rate Constant After Discontinuation of Infusion
timeFrame: 24 hours
measure: Exenatide Area Under the Concentration-time Curve After Discontinuation of Infusion
timeFrame: 24 hours
measure: Median Intensive Care Unit Length of Stay
timeFrame: From enrollment to 30 days post study drug discontinuation
measure: Median Hospital Length of Stay
timeFrame: From enrollment to 30 days post study drug discontinuation
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina; UNC Medical Center
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Nicole R. Pinelli, PharmD
role: PRINCIPAL_INVESTIGATOR
References: