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Intravenous Exenatide in Patients With Acute Brain Injury

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ClinicalTrials.gov Identifier: NCT02058940
Recruitment Status : Completed
First Posted : February 10, 2014
Results First Posted : July 12, 2018
Last Update Posted : July 12, 2018
Sponsor:
Collaborators:
AstraZeneca
Medtronic
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill

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.

Condition or disease Intervention/treatment Phase
Brain Injuries Drug: Exenatide Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Intravenous Exenatide Infusion in Critically Ill Patients With Acute Brain Injury
Study Start Date : August 2015
Actual Primary Completion Date : August 2017
Actual Study Completion Date : August 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Exenatide

Arm Intervention/treatment
Experimental: Exenatide Drug: Exenatide
50 ng/min IV for 30 minutes, then start 25 ng/min IV for a maximum duration of 48 hours




Primary Outcome Measures :
  1. Percentage of Critically Ill Patients With Acute Brain Injury Achieving Pre-specified Feasibility Criteria [ Time Frame: Over 48 hours from infusion initiation ]
    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.


Secondary Outcome Measures :
  1. Median Glucose Concentration During Exenatide Infusion [ Time Frame: Over 48 hours from infusion initiation ]
    Calculated from hourly blood glucose samples starting at infusion initiation over 48 hours

  2. Percentage of Glucose Measurements Within Goal Range [ Time Frame: Over 48 hours from infusion initiation ]
    Percentage of glucose measurements within goal range is calculated as the number of glucose measurements within goal range (110-180 mg/dL) for all patients/total number of glucose measurements collected for all patients.

  3. Median Time to Reach Glucose Measurements Within Goal Range (110-180 mg/dL) [ Time Frame: Over 48 hours from infusion initiation ]
    Calculated from hourly blood glucose samples starting at infusion initiation over 48 hours

  4. Glycemic Variability [ Time Frame: Over 48 hours from infusion initiation ]
    Glycemic variability is defined as the standard deviation of glucose calculated from hourly glucose measurements starting at infusion initiation over 48 hours

  5. Median Insulin Use [ Time Frame: Over 48 hours from infusion initiation ]
    Calculated from number of insulin units administered over 48 hours starting at infusion initiation

  6. Percentage of Patients Requiring Rescue Insulin Infusion Protocol [ Time Frame: Over 48 hours from infusion initiation ]
    Defined as the percentage of patients requiring an insulin infusion to control glucose concentrations during exenatide treatment

  7. Percentage of Hypoglycemic Episodes (<80 mg/dL) [ Time Frame: Over 48 hours from infusion initiation ]
    Percentage of hypoglycemic episodes is calculated as the total number of glucose measurements <80 mg/dL for all patients/total number of glucose measurements collected for all patients.

  8. Percentage of Patients With >1 Episode of Hypoglycemia (<80 mg/dL) [ Time Frame: Over 48 hours from infusion initiation ]
    Calculated from hourly blood glucose samples starting at infusion initiation over 48 hours

  9. Percentage of Patients Experiencing Metabolic Crisis [ Time Frame: Over 48 hours from infusion initiation ]
    Metabolic crisis is defined as cerebral microdialysate glucose concentration <0.7 mmol/L in combination with lactate pyruvate ratio >40. Calculated from hourly microdialysis samples starting at infusion initiation over 48 hours

  10. Median Daily Intracranial Pressure [ Time Frame: Over 48 hours from infusion initiation ]
    Calculated from hourly measurements starting at infusion initiation over 48 hours

  11. Median Daily Cerebral Perfusion Pressure [ Time Frame: Over 48 hours from infusion initiation ]
    Calculated from hourly measurements starting at infusion initiation over 48 hours

  12. Percentage of Hypotensive Episodes (SBP<100 mmHg) [ Time Frame: Over 48 hours from infusion initiation ]
    Defined as the number of hypotensive episodes (SBP<100 mmHg)for all patients/total number of blood pressure measurements collected for all patients.

  13. Percentage of Patients With >1 Episode of Hypotensive Episode (SBP<100 mmHg) [ Time Frame: Over 48 hours from infusion initiation ]
    Calculated from blood pressure measurements starting at infusion initiation over 48 hours

  14. Correlation of Exenatide Concentrations With Creatinine Clearance [ Time Frame: Over 48 hours from infusion initiation ]
    Spearman's correlation coefficient calculated from exenatide concentrations and urine creatinine measurements collected for all patients during the study period. A correlation coefficient is a numerical measure of some type of correlation, meaning a statistical relationship between two variables. Spearman's correlation coefficient assumes values in the range from −1 to +1, where +1 indicates the strongest possible agreement and −1 the strongest possible disagreement.

  15. Exenatide Elimination Rate Constant After Discontinuation of Infusion [ Time Frame: 24 hours ]
  16. Exenatide Area Under the Concentration-time Curve After Discontinuation of Infusion [ Time Frame: 24 hours ]
  17. Median Intensive Care Unit Length of Stay [ Time Frame: From enrollment to 30 days post study drug discontinuation ]
    Defined as the number of days admitted to the Intensive Care Unit

  18. Median Hospital Length of Stay [ Time Frame: From enrollment to 30 days post study drug discontinuation ]
    Defined as the number of days admitted to the hospital



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02058940


Locations
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United States, North Carolina
University of North Carolina; UNC Medical Center
Chapel Hill, North Carolina, United States, 27599
Sponsors and Collaborators
University of North Carolina, Chapel Hill
AstraZeneca
Medtronic
Investigators
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Principal Investigator: Nicole R. Pinelli, PharmD University of North Carolina, Chapel Hill
  Study Documents (Full-Text)

Documents provided by University of North Carolina, Chapel Hill:

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Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT02058940     History of Changes
Other Study ID Numbers: 13-1391
Astra Zeneca Pharmaceuticals ( Other Grant/Funding Number: D5550L00025/ISSEXEN0038 )
Medtronic MiniMed, Inc ( Other Grant/Funding Number: NERP14-008 )
First Posted: February 10, 2014    Key Record Dates
Results First Posted: July 12, 2018
Last Update Posted: July 12, 2018
Last Verified: September 2017
Additional relevant MeSH terms:
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Brain Injuries
Wounds and Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Exenatide
Hypoglycemic Agents
Physiological Effects of Drugs
Anti-Obesity Agents
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists