Phase 4
Completed N=8
Intravenous Exenatide in Patients With Acute Brain Injury
Brain Injuries
Source: ClinicalTrials.gov NCT02058940 ↗
Enrolled (actual)
8
Serious AEs
37.5%
Results posted
Jul 2018
Primary outcomePrimary: Percentage of Critically Ill Patients With Acute Brain Injury Achieving Pre-specified Feasibility Criteria — 0; 87.5; 0 percentage of patients
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Critically Ill Patients With Acute Brain Injury Achieving Pre-specified Feasibility Criteria |
0; 87.5; 0 | — |
| SECONDARY Median Glucose Concentration During Exenatide Infusion |
137.0 | — |
| SECONDARY Percentage of Glucose Measurements Within Goal Range |
69.6 | — |
| SECONDARY Median Time to Reach Glucose Measurements Within Goal Range (110-180 mg/dL) |
200.0 | — |
| SECONDARY Glycemic Variability |
22.2 | — |
| SECONDARY Median Insulin Use |
0.03 | — |
| SECONDARY Percentage of Patients Requiring Rescue Insulin Infusion Protocol |
— | — |
| SECONDARY Percentage of Hypoglycemic Episodes (<80 mg/dL) |
1.2 | — |
| SECONDARY Percentage of Patients With >1 Episode of Hypoglycemia (<80 mg/dL) |
12.5 | — |
| SECONDARY Percentage of Patients Experiencing Metabolic Crisis |
— | — |
| SECONDARY Median Daily Intracranial Pressure |
— | — |
| SECONDARY Median Daily Cerebral Perfusion Pressure |
— | — |
| SECONDARY Percentage of Hypotensive Episodes (SBP<100 mmHg) |
1.2 | — |
| SECONDARY Percentage of Patients With >1 Episode of Hypotensive Episode (SBP<100 mmHg) |
12.5 | — |
| SECONDARY Correlation of Exenatide Concentrations With Creatinine Clearance |
-0.2 | 0.2 |
| SECONDARY Exenatide Elimination Rate Constant After Discontinuation of Infusion |
— | — |
| SECONDARY Exenatide Area Under the Concentration-time Curve After Discontinuation of Infusion |
— | — |
| SECONDARY Median Intensive Care Unit Length of Stay |
9.0 | — |
| SECONDARY Median Hospital Length of Stay |
12.5 | — |
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) 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
Data sourced from ClinicalTrials.gov (NCT02058940). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.