{"protocolSection":{"identificationModule":{"nctId":"NCT02058940","orgStudyIdInfo":{"id":"13-1391"},"secondaryIdInfos":[{"id":"Astra Zeneca Pharmaceuticals","type":"OTHER_GRANT","domain":"D5550L00025/ISSEXEN0038"},{"id":"Medtronic MiniMed, Inc","type":"OTHER_GRANT","domain":"NERP14-008"}],"organization":{"fullName":"University of North Carolina, Chapel Hill","class":"OTHER"},"briefTitle":"Intravenous Exenatide in Patients With Acute Brain Injury","officialTitle":"Intravenous Exenatide Infusion in Critically Ill Patients With Acute Brain Injury"},"statusModule":{"statusVerifiedDate":"2017-09","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2015-08"},"primaryCompletionDateStruct":{"date":"2017-08","type":"ACTUAL"},"completionDateStruct":{"date":"2017-08","type":"ACTUAL"},"studyFirstSubmitDate":"2014-02-06","studyFirstSubmitQcDate":"2014-02-06","studyFirstPostDateStruct":{"date":"2014-02-10","type":"ESTIMATED"},"resultsFirstSubmitDate":"2018-06-01","resultsFirstSubmitQcDate":"2018-07-11","resultsFirstPostDateStruct":{"date":"2018-07-12","type":"ACTUAL"},"lastUpdateSubmitDate":"2018-07-11","lastUpdatePostDateStruct":{"date":"2018-07-12","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"University of North Carolina, Chapel Hill","class":"OTHER"},"collaborators":[{"name":"AstraZeneca","class":"INDUSTRY"},{"name":"Medtronic","class":"INDUSTRY"}]},"oversightModule":{"oversightHasDmc":false},"descriptionModule":{"briefSummary":"The purpose of this study is to assess the feasibility of exenatide infusion for the treatment of high blood sugars following acute brain injury."},"conditionsModule":{"conditions":["Brain Injuries"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE4"],"designInfo":{"allocation":"NA","interventionModel":"SINGLE_GROUP","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"NONE"}},"enrollmentInfo":{"count":8,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Exenatide","type":"EXPERIMENTAL","interventionNames":["Drug: Exenatide"]}],"interventions":[{"type":"DRUG","name":"Exenatide","description":"50 ng/min IV for 30 minutes, then start 25 ng/min IV for a maximum duration of 48 hours","armGroupLabels":["Exenatide"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Percentage of Critically Ill Patients With Acute Brain Injury Achieving Pre-specified Feasibility Criteria","description":"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.","timeFrame":"Over 48 hours from infusion initiation"}],"secondaryOutcomes":[{"measure":"Median Glucose Concentration During Exenatide Infusion","description":"Calculated from hourly blood glucose samples starting at infusion initiation over 48 hours","timeFrame":"Over 48 hours from infusion initiation"},{"measure":"Percentage of Glucose Measurements Within Goal Range","description":"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.","timeFrame":"Over 48 hours from infusion initiation"},{"measure":"Median Time to Reach Glucose Measurements Within Goal Range (110-180 mg/dL)","description":"Calculated from hourly blood glucose samples starting at infusion initiation over 48 hours","timeFrame":"Over 48 hours from infusion initiation"},{"measure":"Glycemic Variability","description":"Glycemic variability is defined as the standard deviation of glucose calculated from hourly glucose measurements starting at infusion initiation over 48 hours","timeFrame":"Over 48 hours from infusion initiation"},{"measure":"Median Insulin Use","description":"Calculated from number of insulin units administered over 48 hours starting at infusion initiation","timeFrame":"Over 48 hours from infusion initiation"},{"measure":"Percentage of Patients Requiring Rescue Insulin Infusion Protocol","description":"Defined as the percentage of patients requiring an insulin infusion to control glucose concentrations during exenatide treatment","timeFrame":"Over 48 hours from infusion initiation"},{"measure":"Percentage of Hypoglycemic Episodes (<80 mg/dL)","description":"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.","timeFrame":"Over 48 hours from infusion initiation"},{"measure":"Percentage of Patients With >1 Episode of Hypoglycemia (<80 mg/dL)","description":"Calculated from hourly blood glucose samples starting at infusion initiation over 48 hours","timeFrame":"Over 48 hours from infusion initiation"},{"measure":"Percentage of Patients Experiencing Metabolic Crisis","description":"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","timeFrame":"Over 48 hours from infusion initiation"},{"measure":"Median Daily Intracranial Pressure","description":"Calculated from hourly measurements starting at infusion initiation over 48 hours","timeFrame":"Over 48 hours from infusion initiation"},{"measure":"Median Daily Cerebral Perfusion Pressure","description":"Calculated from hourly measurements starting at infusion initiation over 48 hours","timeFrame":"Over 48 hours from infusion initiation"},{"measure":"Percentage of Hypotensive Episodes (SBP<100 mmHg)","description":"Defined as the number of hypotensive episodes (SBP\\<100 mmHg)for all patients/total number of blood pressure measurements collected for all patients.","timeFrame":"Over 48 hours from infusion initiation"},{"measure":"Percentage of Patients With >1 Episode of Hypotensive Episode (SBP<100 mmHg)","description":"Calculated from blood pressure measurements starting at infusion initiation over 48 hours","timeFrame":"Over 48 hours from infusion initiation"},{"measure":"Correlation of Exenatide Concentrations With Creatinine Clearance","description":"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.","timeFrame":"Over 48 hours from infusion initiation"},{"measure":"Exenatide Elimination Rate Constant After Discontinuation of Infusion","timeFrame":"24 hours"},{"measure":"Exenatide Area Under the Concentration-time Curve After Discontinuation of Infusion","timeFrame":"24 hours"},{"measure":"Median Intensive Care Unit Length of Stay","description":"Defined as the number of days admitted to the Intensive Care Unit","timeFrame":"From enrollment to 30 days post study drug discontinuation"},{"measure":"Median Hospital Length of Stay","description":"Defined as the number of days admitted to the hospital","timeFrame":"From enrollment to 30 days post study drug discontinuation"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Adults ≥18 years\n* Acute brain injury resulting in admission to the Neurosciences Intensive Care Unit for an anticipated length of stay \\>48 hours\n* Two Blood glucose concentrations \\> 150 mg/dL and ≤300 mg/dL\n* Informed consent obtained via proxy\n\nExclusion Criteria:\n\n* Pregnant (verified by urine or serum pregnancy test within 24 hours of initiation of infusion) or lactating females\n* Type 1 diabetes mellitus\n* History of pancreatitis or risk factors for acute pancreatitis (i.e ethanol abuse, gall stones)\n* Renal insufficiency defined as creatinine clearance (CrCL) \\< 45 mL/min\n* Known history of gastroparesis\n* History of surgery on stomach, esophagus or duodenum\n* Diabetic Ketoacidosis or Hyperosmolar Hyperglycemic Nonketotic Syndrome\n* Concurrent steroid use or planned post-operative steroid use\n* History of organ transplantation\n* Brain death or suspected imminent brain death within the next 72 hours\n* Refractory intracranial hypertension defined as intracranial pressure (ICP) \\> 25 mmHg for greater than 15 minutes and refractory to medical intervention\n* Currently enrolled in another investigational drug or device protocol\n* 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\n* Known allergy to exenatide","healthyVolunteers":false,"sex":"ALL","minimumAge":"18 Years","stdAges":["ADULT","OLDER_ADULT"]},"contactsLocationsModule":{"overallOfficials":[{"name":"Nicole R. Pinelli, PharmD","affiliation":"University of North Carolina, Chapel Hill","role":"PRINCIPAL_INVESTIGATOR"}],"locations":[{"facility":"University of North Carolina; UNC Medical Center","city":"Chapel Hill","state":"North Carolina","zip":"27599","country":"United States","geoPoint":{"lat":35.9132,"lon":-79.05584}}]}},"resultsSection":{"participantFlowModule":{"groups":[{"id":"FG000","title":"Exenatide","description":"Exenatide: 50 ng/min IV for 30 minutes, then start 25 ng/min IV for a maximum duration of 48 hours"}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"8"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"7"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"1"}]}],"dropWithdraws":[{"type":"Discharged from Critical Care Unit","reasons":[{"groupId":"FG000","numSubjects":"1"}]}]}]},"baselineCharacteristicsModule":{"groups":[{"id":"BG000","title":"Exenatide","description":"Exenatide: 50 ng/min IV for 30 minutes, then start 25 ng/min IV for a maximum duration of 48 hours"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"8"}]}],"measures":[{"title":"Age, Continuous","paramType":"MEDIAN","dispersionType":"INTER_QUARTILE_RANGE","unitOfMeasure":"years","classes":[{"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"8"}]}],"categories":[{"measurements":[{"groupId":"BG000","value":"64.0","lowerLimit":"58.8","upperLimit":"67.8"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"8"}]}],"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"1"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"7"}]}]}]},{"title":"Ethnicity (NIH/OMB)","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"8"}]}],"categories":[{"title":"Hispanic or Latino","measurements":[{"groupId":"BG000","value":"0"}]},{"title":"Not Hispanic or Latino","measurements":[{"groupId":"BG000","value":"7"}]},{"title":"Unknown or Not Reported","measurements":[{"groupId":"BG000","value":"1"}]}]}]},{"title":"Race (NIH/OMB)","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"8"}]}],"categories":[{"title":"American Indian or Alaska Native","measurements":[{"groupId":"BG000","value":"0"}]},{"title":"Asian","measurements":[{"groupId":"BG000","value":"0"}]},{"title":"Native Hawaiian or Other Pacific Islander","measurements":[{"groupId":"BG000","value":"0"}]},{"title":"Black or African American","measurements":[{"groupId":"BG000","value":"3"}]},{"title":"White","measurements":[{"groupId":"BG000","value":"4"}]},{"title":"More than one race","measurements":[{"groupId":"BG000","value":"0"}]},{"title":"Unknown or Not Reported","measurements":[{"groupId":"BG000","value":"1"}]}]}]},{"title":"Region of Enrollment","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"title":"United States","denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"8"}]}],"categories":[{"measurements":[{"groupId":"BG000","value":"8"}]}]}]},{"title":"Primary Admitting Diagnosis","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"title":"Intracerebral Hemorrhage","denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"8"}]}],"categories":[{"measurements":[{"groupId":"BG000","value":"3"}]}]},{"title":"Acute Ischemic Stroke","denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"8"}]}],"categories":[{"measurements":[{"groupId":"BG000","value":"3"}]}]},{"title":"Subarachnoid Hemorrhage","denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"8"}]}],"categories":[{"measurements":[{"groupId":"BG000","value":"1"}]}]},{"title":"Subdural Hematoma","denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"8"}]}],"categories":[{"measurements":[{"groupId":"BG000","value":"1"}]}]}]},{"title":"Glasgow Coma Scale (GCS)","description":"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.","paramType":"MEDIAN","dispersionType":"INTER_QUARTILE_RANGE","unitOfMeasure":"units on a scale","classes":[{"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"8"}]}],"categories":[{"measurements":[{"groupId":"BG000","value":"10.5","lowerLimit":"7.0","upperLimit":"14.0"}]}]}]},{"title":"Sequential Organ Failure Assessment (SOFA)","description":"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).","paramType":"MEDIAN","dispersionType":"INTER_QUARTILE_RANGE","unitOfMeasure":"units on a scale","classes":[{"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"8"}]}],"categories":[{"measurements":[{"groupId":"BG000","value":"2.0","lowerLimit":"1.0","upperLimit":"4.0"}]}]}]},{"title":"Hunt and Hess Scale","description":"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.","populationDescription":"Hunt and Hess Grade is only reported for patients with an admitting diagnosis of Subarachnoid Hemorrhage","paramType":"NUMBER","unitOfMeasure":"units on a scale","classes":[{"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"1"}]}],"categories":[{"measurements":[{"groupId":"BG000","value":"2.0"}]}]}]},{"title":"Modified Fisher Grade","description":"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).","populationDescription":"Modified Fisher Grade is only reported for patients with an admitting diagnosis of Subarachnoid Hemorrhage","paramType":"NUMBER","unitOfMeasure":"units on a scale","classes":[{"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"1"}]}],"categories":[{"measurements":[{"groupId":"BG000","value":"3.0"}]}]}]},{"title":"Intracranial Pressure","description":"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.","populationDescription":"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.","paramType":"MEDIAN","dispersionType":"INTER_QUARTILE_RANGE","unitOfMeasure":"mmHg","classes":[{"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"0"}]}]}]},{"title":"Cerebral Perfusion Pressure","description":"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).","populationDescription":"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.","paramType":"MEDIAN","dispersionType":"INTER_QUARTILE_RANGE","unitOfMeasure":"mmHg","classes":[{"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"0"}]}]}]},{"title":"Past Medical History","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"title":"Diabetes","denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"8"}]}],"categories":[{"measurements":[{"groupId":"BG000","value":"4"}]}]},{"title":"Hypertension","denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"8"}]}],"categories":[{"measurements":[{"groupId":"BG000","value":"6"}]}]},{"title":"Hyperlipidemia","denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"8"}]}],"categories":[{"measurements":[{"groupId":"BG000","value":"4"}]}]},{"title":"Cardiovascular Disease","denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"8"}]}],"categories":[{"measurements":[{"groupId":"BG000","value":"5"}]}]},{"title":"Chronic Kidney Disease","denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"8"}]}],"categories":[{"measurements":[{"groupId":"BG000","value":"3"}]}]},{"title":"Heart Failure","denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"8"}]}],"categories":[{"measurements":[{"groupId":"BG000","value":"1"}]}]}]},{"title":"Hemoglobin A1c (%)","paramType":"MEDIAN","dispersionType":"INTER_QUARTILE_RANGE","unitOfMeasure":"percent","classes":[{"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"8"}]}],"categories":[{"measurements":[{"groupId":"BG000","value":"6.5","lowerLimit":"5.5","upperLimit":"7.3"}]}]}]},{"title":"Glucose","paramType":"MEDIAN","dispersionType":"INTER_QUARTILE_RANGE","unitOfMeasure":"mg/dL","classes":[{"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"8"}]}],"categories":[{"measurements":[{"groupId":"BG000","value":"191.0","lowerLimit":"159.0","upperLimit":"224.0"}]}]}]},{"title":"Intensive Care Unit (ICU) Day of Study Drug Administration","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"title":"Day 1","denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"8"}]}],"categories":[{"measurements":[{"groupId":"BG000","value":"4"}]}]},{"title":"Day 2","denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"8"}]}],"categories":[{"measurements":[{"groupId":"BG000","value":"4"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Percentage of Critically Ill Patients With Acute Brain Injury Achieving Pre-specified Feasibility Criteria","description":"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.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"percentage of patients","timeFrame":"Over 48 hours from infusion initiation","groups":[{"id":"OG000","title":"Exenatide","description":"Exenatide: 50 ng/min IV for 30 minutes, then start 25 ng/min IV for a maximum duration of 48 hours"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"8"}]}],"classes":[{"title":"Percentage Experiencing Severe Hypoglycemia","categories":[{"measurements":[{"groupId":"OG000","value":"0"}]}]},{"title":"Percentage Achieving Glucose within Goal","categories":[{"measurements":[{"groupId":"OG000","value":"87.5"}]}]},{"title":"Percentage with Nausea Requiring Discontinuation","categories":[{"measurements":[{"groupId":"OG000","value":"0"}]}]}]},{"type":"SECONDARY","title":"Median Glucose Concentration During Exenatide Infusion","description":"Calculated from hourly blood glucose samples starting at infusion initiation over 48 hours","reportingStatus":"POSTED","paramType":"MEDIAN","dispersionType":"Inter-Quartile Range","unitOfMeasure":"mg/dL","timeFrame":"Over 48 hours from infusion initiation","groups":[{"id":"OG000","title":"Exenatide","description":"Exenatide: 50 ng/min IV for 30 minutes, then start 25 ng/min IV for a maximum duration of 48 hours"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"8"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"137.0","lowerLimit":"118.0","upperLimit":"164.3"}]}]}]},{"type":"SECONDARY","title":"Percentage of Glucose Measurements Within Goal Range","description":"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.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"percentage of measurements","timeFrame":"Over 48 hours from infusion initiation","groups":[{"id":"OG000","title":"Exenatide","description":"Exenatide: 50 ng/min IV for 30 minutes, then start 25 ng/min IV for a maximum duration of 48 hours"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"8"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"69.6"}]}]}]},{"type":"SECONDARY","title":"Median Time to Reach Glucose Measurements Within Goal Range (110-180 mg/dL)","description":"Calculated from hourly blood glucose samples starting at infusion initiation over 48 hours","reportingStatus":"POSTED","paramType":"MEDIAN","dispersionType":"Inter-Quartile Range","unitOfMeasure":"minutes","timeFrame":"Over 48 hours from infusion initiation","groups":[{"id":"OG000","title":"Exenatide","description":"Exenatide: 50 ng/min IV for 30 minutes, then start 25 ng/min IV for a maximum duration of 48 hours"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"8"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"200.0","lowerLimit":"72.5","upperLimit":"270.5"}]}]}]},{"type":"SECONDARY","title":"Glycemic Variability","description":"Glycemic variability is defined as the standard deviation of glucose calculated from hourly glucose measurements starting at infusion initiation over 48 hours","reportingStatus":"POSTED","paramType":"MEDIAN","dispersionType":"Inter-Quartile Range","unitOfMeasure":"mg/dL","timeFrame":"Over 48 hours from infusion initiation","groups":[{"id":"OG000","title":"Exenatide","description":"Exenatide: 50 ng/min IV for 30 minutes, then start 25 ng/min IV for a maximum duration of 48 hours"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"8"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"22.2","lowerLimit":"15.0","upperLimit":"36.3"}]}]}]},{"type":"SECONDARY","title":"Median Insulin Use","description":"Calculated from number of insulin units administered over 48 hours starting at infusion initiation","reportingStatus":"POSTED","paramType":"MEDIAN","dispersionType":"Inter-Quartile Range","unitOfMeasure":"units/kg","timeFrame":"Over 48 hours from infusion initiation","groups":[{"id":"OG000","title":"Exenatide","description":"Exenatide: 50 ng/min IV for 30 minutes, then start 25 ng/min IV for a maximum duration of 48 hours"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"8"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0.03","lowerLimit":"0.0","upperLimit":"0.3"}]}]}]},{"type":"SECONDARY","title":"Percentage of Patients Requiring Rescue Insulin Infusion Protocol","description":"Defined as the percentage of patients requiring an insulin infusion to control glucose concentrations during exenatide treatment","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"percentage of patients","timeFrame":"Over 48 hours from infusion initiation","groups":[{"id":"OG000","title":"Exenatide","description":"Exenatide: 50 ng/min IV for 30 minutes, then start 25 ng/min IV for a maximum duration of 48 hours"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"8"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"0"}]}]}]},{"type":"SECONDARY","title":"Percentage of Hypoglycemic Episodes (<80 mg/dL)","description":"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.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"percentage of measurements","timeFrame":"Over 48 hours from infusion initiation","groups":[{"id":"OG000","title":"Exenatide","description":"Exenatide: 50 ng/min IV for 30 minutes, then start 25 ng/min IV for a maximum duration of 48 hours"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"8"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"1.2"}]}]}]},{"type":"SECONDARY","title":"Percentage of Patients With >1 Episode of Hypoglycemia (<80 mg/dL)","description":"Calculated from hourly blood glucose samples starting at infusion initiation over 48 hours","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"percentage of patients","timeFrame":"Over 48 hours from infusion initiation","groups":[{"id":"OG000","title":"Exenatide","description":"Exenatide: 50 ng/min IV for 30 minutes, then start 25 ng/min IV for a maximum duration of 48 hours"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"8"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"12.5"}]}]}]},{"type":"SECONDARY","title":"Percentage of Patients Experiencing Metabolic Crisis","description":"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","populationDescription":"No patients received invasive intracranial multimodal monitoring as a part of their standard of care, as such, these endpoints were not collected.","reportingStatus":"POSTED","timeFrame":"Over 48 hours from infusion initiation","groups":[{"id":"OG000","title":"Exenatide","description":"Exenatide: 50 ng/min IV for 30 minutes, then start 25 ng/min IV for a maximum duration of 48 hours"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"0"}]}]},{"type":"SECONDARY","title":"Median Daily Intracranial Pressure","description":"Calculated from hourly measurements starting at infusion initiation over 48 hours","populationDescription":"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.","reportingStatus":"POSTED","timeFrame":"Over 48 hours from infusion initiation","groups":[{"id":"OG000","title":"Exenatide","description":"Exenatide: 50 ng/min IV for 30 minutes, then start 25 ng/min IV for a maximum duration of 48 hours"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"0"}]}]},{"type":"SECONDARY","title":"Median Daily Cerebral Perfusion Pressure","description":"Calculated from hourly measurements starting at infusion initiation over 48 hours","populationDescription":"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.","reportingStatus":"POSTED","timeFrame":"Over 48 hours from infusion initiation","groups":[{"id":"OG000","title":"Exenatide","description":"Exenatide: 50 ng/min IV for 30 minutes, then start 25 ng/min IV for a maximum duration of 48 hours"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"0"}]}]},{"type":"SECONDARY","title":"Percentage of Hypotensive Episodes (SBP<100 mmHg)","description":"Defined as the number of hypotensive episodes (SBP\\<100 mmHg)for all patients/total number of blood pressure measurements collected for all patients.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"percentage of measurements","timeFrame":"Over 48 hours from infusion initiation","groups":[{"id":"OG000","title":"Exenatide","description":"Exenatide: 50 ng/min IV for 30 minutes, then start 25 ng/min IV for a maximum duration of 48 hours"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"8"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"1.2"}]}]}]},{"type":"SECONDARY","title":"Percentage of Patients With >1 Episode of Hypotensive Episode (SBP<100 mmHg)","description":"Calculated from blood pressure measurements starting at infusion initiation over 48 hours","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"percentage of patients","timeFrame":"Over 48 hours from infusion initiation","groups":[{"id":"OG000","title":"Exenatide","description":"Exenatide: 50 ng/min IV for 30 minutes, then start 25 ng/min IV for a maximum duration of 48 hours"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"8"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"12.5"}]}]}]},{"type":"SECONDARY","title":"Correlation of Exenatide Concentrations With Creatinine Clearance","description":"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.","reportingStatus":"POSTED","paramType":"NUMBER","unitOfMeasure":"correlation coefficient","timeFrame":"Over 48 hours from infusion initiation","groups":[{"id":"OG000","title":"Exenatide","description":"Exenatide: 50 ng/min IV for 30 minutes, then start 25 ng/min IV for a maximum duration of 48 hours"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"7"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"-0.2"}]}]}],"analyses":[{"groupIds":["OG000"],"nonInferiorityType":"OTHER","pValue":"0.2","statisticalMethod":"Spearman's Correlation Coefficient"}]},{"type":"SECONDARY","title":"Exenatide Elimination Rate Constant After Discontinuation of Infusion","populationDescription":"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.","reportingStatus":"POSTED","timeFrame":"24 hours","groups":[{"id":"OG000","title":"Exenatide","description":"Exenatide: 50 ng/min IV for 30 minutes, then start 25 ng/min IV for a maximum duration of 48 hours"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"0"}]}]},{"type":"SECONDARY","title":"Exenatide Area Under the Concentration-time Curve After Discontinuation of Infusion","populationDescription":"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.","reportingStatus":"POSTED","timeFrame":"24 hours","groups":[{"id":"OG000","title":"Exenatide","description":"Exenatide: 50 ng/min IV for 30 minutes, then start 25 ng/min IV for a maximum duration of 48 hours"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"0"}]}]},{"type":"SECONDARY","title":"Median Intensive Care Unit Length of Stay","description":"Defined as the number of days admitted to the Intensive Care Unit","reportingStatus":"POSTED","paramType":"MEDIAN","dispersionType":"Inter-Quartile Range","unitOfMeasure":"days","timeFrame":"From enrollment to 30 days post study drug discontinuation","groups":[{"id":"OG000","title":"Exenatide","description":"Exenatide: 50 ng/min IV for 30 minutes, then start 25 ng/min IV for a maximum duration of 48 hours"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"8"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"9.0","lowerLimit":"7.8","upperLimit":"14.8"}]}]}]},{"type":"SECONDARY","title":"Median Hospital Length of Stay","description":"Defined as the number of days admitted to the hospital","reportingStatus":"POSTED","paramType":"MEDIAN","dispersionType":"Inter-Quartile Range","unitOfMeasure":"days","timeFrame":"From enrollment to 30 days post study drug discontinuation","groups":[{"id":"OG000","title":"Exenatide","description":"Exenatide: 50 ng/min IV for 30 minutes, then start 25 ng/min IV for a maximum duration of 48 hours"}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"8"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"12.5","lowerLimit":"9.0","upperLimit":"27.3"}]}]}]}]},"adverseEventsModule":{"frequencyThreshold":"5","timeFrame":"From study enrollment to 30 days post discontinuation of Exenatide, up to 1 month","eventGroups":[{"id":"EG000","title":"Exenatide","description":"Exenatide: 50 ng/min IV for 30 minutes, then start 25 ng/min IV for a maximum duration of 48 hours","deathsNumAffected":3,"deathsNumAtRisk":8,"seriousNumAffected":3,"seriousNumAtRisk":8,"otherNumAffected":0,"otherNumAtRisk":8}],"seriousEvents":[{"term":"Death","organSystem":"Nervous system disorders","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","notes":"All 3 patients completed study treatment. Cause of death due to underlying neurological injury with family deciding to place patients on comfort care.","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":8}]}]},"moreInfoModule":{"limitationsAndCaveats":{"description":"Trial ended early and did not achieve targeted recruitment goals."},"certainAgreement":{"piSponsorEmployee":true},"pointOfContact":{"title":"Nicole R. Pinelli","organization":"The University of North Carolina at Chapel Hill","email":"nickipinelli@unc.edu","phone":"919-962-1641"}}},"documentSection":{"largeDocumentModule":{"largeDocs":[{"typeAbbrev":"Prot_SAP","hasProtocol":true,"hasSap":true,"hasIcf":false,"label":"Study Protocol and Statistical Analysis Plan","date":"2015-08-18","uploadDate":"2018-06-01T12:06","filename":"Prot_SAP_000.pdf","size":301726}]}},"derivedSection":{"miscInfoModule":{"versionHolder":"2026-10-09"},"conditionBrowseModule":{"meshes":[{"id":"D001930","term":"Brain Injuries"}],"ancestors":[{"id":"D001927","term":"Brain Diseases"},{"id":"D002493","term":"Central Nervous System Diseases"},{"id":"D009422","term":"Nervous System Diseases"},{"id":"D006259","term":"Craniocerebral Trauma"},{"id":"D020196","term":"Trauma, Nervous System"},{"id":"D014947","term":"Wounds and Injuries"}]},"interventionBrowseModule":{"meshes":[{"id":"D000077270","term":"Exenatide"}],"ancestors":[{"id":"D010455","term":"Peptides"},{"id":"D000602","term":"Amino Acids, Peptides, and Proteins"},{"id":"D014688","term":"Venoms"},{"id":"D045424","term":"Complex Mixtures"},{"id":"D014118","term":"Toxins, Biological"},{"id":"D001685","term":"Biological Factors"}]}},"hasResults":true}