Intravenous Exenatide in Patients With Acute Brain Injury

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-08-31

Study Completion Date

2017-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Dexmedetomidine on Brain Injury Patients

NCT06661980

Brain Injuries

COMPLETED NA

Neuroprotective Effect of Dexomitomidine

NCT05487742

Dexmedetomidine Neuroprotective Effect in Traumatic Brain Injury

UNKNOWN PHASE1

An Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics Study of JNJ-17299425 in Participants With Traumatic Brain Injury

NCT01814982

Traumatic Brain Injury

TERMINATED PHASE2

Study of Cerebrolysin for Treatment of Infants With History of Neonatal Hypoxic Ischemic Encephalopathy

NCT01059461

Hypoxic-Ischemic Encephalopathy

COMPLETED PHASE2

The Use of Low Molecular Weight Heparin in Traumatic Brain Injury

NCT00170378

Brain Injury Venous Thrombosis

COMPLETED PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Brain Injuries

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Exenatide

Group Type EXPERIMENTAL

Exenatide

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Exenatide

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

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No