Ignite Creation Date:
2025-12-24 @ 5:36 PM
Ignite Modification Date:
2025-12-25 @ 3:07 PM
Study NCT ID:
NCT00247468
Status:
WITHDRAWN
Last Update Posted:
2017-01-23
First Post:
2005-11-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Strict Glucose Control of Pediatric Intensive Care Unit (ICU) Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}, 'conditionBrowseModule': {'meshes': [{'id': 'D012131', 'term': 'Respiratory Insufficiency'}, {'id': 'D018805', 'term': 'Sepsis'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}], 'ancestors': [{'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D018746', 'term': 'Systemic Inflammatory Response Syndrome'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Never received IRB approval', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2004-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-01', 'completionDateStruct': {'date': '2004-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-01-19', 'studyFirstSubmitDate': '2005-11-01', 'studyFirstSubmitQcDate': '2005-11-01', 'lastUpdatePostDateStruct': {'date': '2017-01-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-11-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2004-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '30-day mortality rate from the time of enrollment'}], 'secondaryOutcomes': [{'measure': 'Pediatric Overall Performance Category scores at ICU discharge and 6 months post-discharge'}, {'measure': 'rates of nosocomial bloodstream infections'}, {'measure': 'time to resolution of organ failure (mechanical ventilator days and days of vasopressor support)'}, {'measure': 'change in Pediatric Logistic Organ Dysfunction scores'}, {'measure': 'requirement of dialysis or hemofiltration for patients with acute renal failure'}, {'measure': 'volume of blood product transfusions per kilogram body weight (vol/kg).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Respiratory Failure', 'Cardiovascular Failure', 'Sepsis', 'Trauma']}, 'descriptionModule': {'briefSummary': 'The study objective is to improve morbidity and mortality of high-risk critically ill children. Our hypothesis is that a strict ICU glucose control protocol will decrease morbidity and mortality associated with hyperglycemia in a population of high-risk critically ill pediatric patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '21 Years', 'minimumAge': '1 Month', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Vasoactive infusion (e.g. dopamine, epinephrine, norepinephrine) and/or\n* Invasive mechanical ventilation\n* Age between 1 mo and 21 yrs\n\nExclusion Criteria:\n\n* Type I diabetes mellitus\n* Have an illness that requires insulin daily\n* Recipients of solid organ transplants\n* Participation in an experimental trial that might affect outcome\n* Post-operative patients with planned extubation upon recovery\n* Patients on a dopamine infusion of less than 3 mcg/kg/minute'}, 'identificationModule': {'nctId': 'NCT00247468', 'briefTitle': 'Strict Glucose Control of Pediatric Intensive Care Unit (ICU) Patients', 'organization': {'class': 'OTHER', 'fullName': "Children's Hospital of Philadelphia"}, 'officialTitle': 'Strict Glucose Control of Pediatric ICU Patients to Reduce Mortality and Morbidity', 'orgStudyIdInfo': {'id': '2003-2-3160'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Strict Glucose Control', 'type': 'PROCEDURE'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Vinay Nadkarni, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Children's Hospital of Philadelphia"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Children's Hospital of Philadelphia", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}