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Completed

NCT Number: NCT02058940

Intravenous Exenatide in Patients With Acute Brain Injury

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

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Key information

Conditions

Brain Injuries Brain Diseases Central Nervous System Diseases Craniocerebral Trauma Nervous System Diseases Trauma, Nervous System Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of North Carolina; UNC Medical Center

Chapel Hill, North Carolina, 27599, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

exenatide

Drug

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

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Collaborators

  • AstraZeneca
  • Medtronic

Registry information

Official study title

Intravenous Exenatide Infusion in Critically Ill Patients With Acute Brain Injury

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Feb 10, 2014
Registry last updated
Jul 12, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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