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| ID | Type | Description | Link |
|---|---|---|---|
| Astra Zeneca Pharmaceuticals | Other Grant/Funding Number | D5550L00025/ISSEXEN0038 | |
| Medtronic MiniMed, Inc | Other Grant/Funding Number | NERP14-008 |
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| Name | Class |
|---|---|
| AstraZeneca | INDUSTRY |
| Medtronic | INDUSTRY |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exenatide | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exenatide | Drug | 50 ng/min IV for 30 minutes, then start 25 ng/min IV for a maximum duration of 48 hours |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Critically Ill Patients With Acute Brain Injury Achieving Pre-specified Feasibility Criteria | 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. | Over 48 hours from infusion initiation |
| Measure | Description | Time Frame |
|---|---|---|
| Median Glucose Concentration During Exenatide Infusion | Calculated from hourly blood glucose samples starting at infusion initiation over 48 hours | Over 48 hours from infusion initiation |
| Percentage of Glucose Measurements Within Goal Range |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nicole R. Pinelli, PharmD | University of North Carolina, Chapel Hill | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of North Carolina; UNC Medical Center | Chapel Hill | North Carolina | 27599 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Exenatide | Exenatide: 50 ng/min IV for 30 minutes, then start 25 ng/min IV for a maximum duration of 48 hours |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Exenatide | Exenatide: 50 ng/min IV for 30 minutes, then start 25 ng/min IV for a maximum duration of 48 hours |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Critically Ill Patients With Acute Brain Injury Achieving Pre-specified Feasibility Criteria | 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. | Posted | Number | percentage of patients | Over 48 hours from infusion initiation |
|
From study enrollment to 30 days post discontinuation of Exenatide, up to 1 month
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Exenatide | Exenatide: 50 ng/min IV for 30 minutes, then start 25 ng/min IV for a maximum duration of 48 hours |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death | Nervous system disorders | Non-systematic Assessment | All 3 patients completed study treatment. Cause of death due to underlying neurological injury with family deciding to place patients on comfort care. |
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Trial ended early and did not achieve targeted recruitment goals.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Nicole R. Pinelli | The University of North Carolina at Chapel Hill | 919-962-1641 | nickipinelli@unc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 18, 2015 | Jun 1, 2018 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001930 | Brain Injuries |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D006259 | Craniocerebral Trauma |
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| ID | Term |
|---|---|
| D000077270 | Exenatide |
| ID | Term |
|---|---|
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D014688 | Venoms |
| D045424 | Complex Mixtures |
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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.
| Over 48 hours from infusion initiation |
| Median Time to Reach Glucose Measurements Within Goal Range (110-180 mg/dL) | Calculated from hourly blood glucose samples starting at infusion initiation over 48 hours | Over 48 hours from infusion initiation |
| Glycemic Variability | Glycemic variability is defined as the standard deviation of glucose calculated from hourly glucose measurements starting at infusion initiation over 48 hours | Over 48 hours from infusion initiation |
| Median Insulin Use | Calculated from number of insulin units administered over 48 hours starting at infusion initiation | Over 48 hours from infusion initiation |
| Percentage of Patients Requiring Rescue Insulin Infusion Protocol | Defined as the percentage of patients requiring an insulin infusion to control glucose concentrations during exenatide treatment | Over 48 hours from infusion initiation |
| Percentage of Hypoglycemic Episodes (<80 mg/dL) | 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. | Over 48 hours from infusion initiation |
| Percentage of Patients With >1 Episode of Hypoglycemia (<80 mg/dL) | Calculated from hourly blood glucose samples starting at infusion initiation over 48 hours | Over 48 hours from infusion initiation |
| Percentage of Patients Experiencing Metabolic Crisis | 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 | Over 48 hours from infusion initiation |
| Median Daily Intracranial Pressure | Calculated from hourly measurements starting at infusion initiation over 48 hours | Over 48 hours from infusion initiation |
| Median Daily Cerebral Perfusion Pressure | Calculated from hourly measurements starting at infusion initiation over 48 hours | Over 48 hours from infusion initiation |
| Percentage of Hypotensive Episodes (SBP<100 mmHg) | Defined as the number of hypotensive episodes (SBP<100 mmHg)for all patients/total number of blood pressure measurements collected for all patients. | Over 48 hours from infusion initiation |
| Percentage of Patients With >1 Episode of Hypotensive Episode (SBP<100 mmHg) | Calculated from blood pressure measurements starting at infusion initiation over 48 hours | Over 48 hours from infusion initiation |
| Correlation of Exenatide Concentrations With Creatinine Clearance | 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. | Over 48 hours from infusion initiation |
| Exenatide Elimination Rate Constant After Discontinuation of Infusion | 24 hours |
| Exenatide Area Under the Concentration-time Curve After Discontinuation of Infusion | 24 hours |
| Median Intensive Care Unit Length of Stay | Defined as the number of days admitted to the Intensive Care Unit | From enrollment to 30 days post study drug discontinuation |
| Median Hospital Length of Stay | Defined as the number of days admitted to the hospital | From enrollment to 30 days post study drug discontinuation |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Primary Admitting Diagnosis | Count of Participants | Participants |
|
| Glasgow Coma Scale (GCS) | The Glasgow Coma Scale (GCS) aims to give a reliable and objective way of recording the conscious state of a person in response to defined stimuli. A patient is assessed against criteria of the scale, and the resulting points give a patient score between 3 and 15. Lower scores reflect a deeper state of unconsciousness. | Median | Inter-Quartile Range | units on a scale |
|
| Sequential Organ Failure Assessment (SOFA) | Sequential Organ Failure Assessment (SOFA) score evaluates six systems: respiratory, cardiovascular, coagulation, hepatic, renal and neurological. Each system gets a score from 0 (normal) to 4 (abnormal) and the sum of each score defines the final SOFA score, where 24 is the maximum score (high risk of mortality) and 0 is the minimum score (low risk of mortality). | Median | Inter-Quartile Range | units on a scale |
|
| Hunt and Hess Scale | The Hunt and Hess scale is one of the grading systems used to classify the severity of a subarachnoid hemorrhage. It gives an index of the mortality associated with the various grades. The mortality is lowest with grade 1 and highest with grade 5. | Hunt and Hess Grade is only reported for patients with an admitting diagnosis of Subarachnoid Hemorrhage | Number | units on a scale |
|
| Modified Fisher Grade | The Modified Fisher Grade classifies the appearance of subarachnoid hemorrhage on CT scan. The appearance of the hemorrhage is determined on a scale of 0 (none evident) to 4 (most severe). | Modified Fisher Grade is only reported for patients with an admitting diagnosis of Subarachnoid Hemorrhage | Number | units on a scale |
|
| Intracranial Pressure | Intracranial pressure (ICP) is the pressure inside the skull and thus in the brain tissue and cerebrospinal fluid (CSF). ICP is measured in millimeters of mercury (mmHg) and, at rest, is normally 7-15 mmHg. | ICP is only reported in patients with Subarachnoid Hemorrhage. No patients with an admitting diagnosis of Subarachnoid Hemorrhage received ICP monitoring as part of standard of care and therefore data is not reported. | Median | Inter-Quartile Range | mmHg |
|
| Cerebral Perfusion Pressure | Cerebral perfusion pressure, or CPP, is the net pressure gradient causing cerebral blood flow to the brain (brain perfusion). It must be maintained within narrow limits because too little pressure could cause brain tissue to become ischemic (having inadequate blood flow), and too much could raise intracranial pressure (ICP). | CPP is only reported in patients with Subarachnoid Hemorrhage. No patients with an admitting diagnosis of Subarachnoid Hemorrhage received CPP monitoring as part of standard of care and therefore data is not reported. | Median | Inter-Quartile Range | mmHg |
|
| Past Medical History | Count of Participants | Participants |
|
| Hemoglobin A1c (%) | Median | Inter-Quartile Range | percent |
|
| Glucose | Median | Inter-Quartile Range | mg/dL |
|
| Intensive Care Unit (ICU) Day of Study Drug Administration | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Median Glucose Concentration During Exenatide Infusion | Calculated from hourly blood glucose samples starting at infusion initiation over 48 hours | Posted | Median | Inter-Quartile Range | mg/dL | Over 48 hours from infusion initiation |
|
|
|
| Secondary | Percentage of Glucose Measurements Within Goal Range | 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. | Posted | Number | percentage of measurements | Over 48 hours from infusion initiation |
|
|
|
| Secondary | Median Time to Reach Glucose Measurements Within Goal Range (110-180 mg/dL) | Calculated from hourly blood glucose samples starting at infusion initiation over 48 hours | Posted | Median | Inter-Quartile Range | minutes | Over 48 hours from infusion initiation |
|
|
|
| Secondary | Glycemic Variability | Glycemic variability is defined as the standard deviation of glucose calculated from hourly glucose measurements starting at infusion initiation over 48 hours | Posted | Median | Inter-Quartile Range | mg/dL | Over 48 hours from infusion initiation |
|
|
|
| Secondary | Median Insulin Use | Calculated from number of insulin units administered over 48 hours starting at infusion initiation | Posted | Median | Inter-Quartile Range | units/kg | Over 48 hours from infusion initiation |
|
|
|
| Secondary | Percentage of Patients Requiring Rescue Insulin Infusion Protocol | Defined as the percentage of patients requiring an insulin infusion to control glucose concentrations during exenatide treatment | Posted | Number | percentage of patients | Over 48 hours from infusion initiation |
|
|
|
| Secondary | Percentage of Hypoglycemic Episodes (<80 mg/dL) | 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. | Posted | Number | percentage of measurements | Over 48 hours from infusion initiation |
|
|
|
| Secondary | Percentage of Patients With >1 Episode of Hypoglycemia (<80 mg/dL) | Calculated from hourly blood glucose samples starting at infusion initiation over 48 hours | Posted | Number | percentage of patients | Over 48 hours from infusion initiation |
|
|
|
| Secondary | Percentage of Patients Experiencing Metabolic Crisis | 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 | No patients received invasive intracranial multimodal monitoring as a part of their standard of care, as such, these endpoints were not collected. | Posted | Over 48 hours from infusion initiation |
|
|
| Secondary | Median Daily Intracranial Pressure | Calculated from hourly measurements starting at infusion initiation over 48 hours | No patients with an admitting diagnosis of Subarachnoid Hemorrhage received ICP or CPP monitoring as part of standard of care and therefore data is not reported. | Posted | Over 48 hours from infusion initiation |
|
|
| Secondary | Median Daily Cerebral Perfusion Pressure | Calculated from hourly measurements starting at infusion initiation over 48 hours | No patients with an admitting diagnosis of Subarachnoid Hemorrhage received ICP or CPP monitoring as part of standard of care and therefore data is not reported. | Posted | Over 48 hours from infusion initiation |
|
|
| Secondary | Percentage of Hypotensive Episodes (SBP<100 mmHg) | Defined as the number of hypotensive episodes (SBP<100 mmHg)for all patients/total number of blood pressure measurements collected for all patients. | Posted | Number | percentage of measurements | Over 48 hours from infusion initiation |
|
|
|
| Secondary | Percentage of Patients With >1 Episode of Hypotensive Episode (SBP<100 mmHg) | Calculated from blood pressure measurements starting at infusion initiation over 48 hours | Posted | Number | percentage of patients | Over 48 hours from infusion initiation |
|
|
|
| Secondary | Correlation of Exenatide Concentrations With Creatinine Clearance | 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. | Posted | Number | correlation coefficient | Over 48 hours from infusion initiation |
|
|
|
|
| Secondary | Exenatide Elimination Rate Constant After Discontinuation of Infusion | The institutional review board requested the study team limit exenatide concentration sampling to during the infusion. Samples were not collected after discontinuation of study drug. As such, this pharmacokinetic parameter is not reported. | Posted | 24 hours |
|
|
| Secondary | Exenatide Area Under the Concentration-time Curve After Discontinuation of Infusion | The institutional review board requested the study team limit exenatide concentration sampling to during the infusion. Samples were not collected after discontinuation of study drug. As such, this pharmacokinetic parameter is not reported. | Posted | 24 hours |
|
|
| Secondary | Median Intensive Care Unit Length of Stay | Defined as the number of days admitted to the Intensive Care Unit | Posted | Median | Inter-Quartile Range | days | From enrollment to 30 days post study drug discontinuation |
|
|
|
| Secondary | Median Hospital Length of Stay | Defined as the number of days admitted to the hospital | Posted | Median | Inter-Quartile Range | days | From enrollment to 30 days post study drug discontinuation |
|
|
|
| 3 |
| 8 |
| 3 |
| 8 |
| 0 |
| 8 |
|
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| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
| D014118 |
| Toxins, Biological |
| D001685 | Biological Factors |