Ignite Creation Date:
2025-12-25 @ 5:11 AM
Ignite Modification Date:
2025-12-26 @ 4:16 AM
Study NCT ID:
NCT03293927
Status:
WITHDRAWN
Last Update Posted:
2019-07-18
First Post:
2017-09-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Polypharmacy-related Adverse Events in Critically Ill Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003693', 'term': 'Delirium'}], 'ancestors': [{'id': 'D003221', 'term': 'Confusion'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005283', 'term': 'Fentanyl'}, {'id': 'D020927', 'term': 'Dexmedetomidine'}], 'ancestors': [{'id': 'D010880', 'term': 'Piperidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'No participants enrolled in study.', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2018-04-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-10', 'completionDateStruct': {'date': '2019-07-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-07-16', 'studyFirstSubmitDate': '2017-09-21', 'studyFirstSubmitQcDate': '2017-09-21', 'lastUpdatePostDateStruct': {'date': '2019-07-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-09-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-07-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in delirium scores as measured by CAPD score', 'timeFrame': 'up to 10 days'}], 'secondaryOutcomes': [{'measure': 'Drug level associated with CAPD score', 'timeFrame': 'up to 10 days'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['children, mechanically ventilated, fentanyl, dexmedetomidine, delirium, polypharmacy'], 'conditions': ['Delirium']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to learn how 2 medications (fentanyl and dexmedetomidine) affect how sick children think and interact with their environments.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '2 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Ages 2-\\<18 at the time of enrollment\n* Admitted to the Duke PICU or PCICU\n* Planned or anticipated mechanically ventilation for ≥2 days\n* Require sedation to maintain mechanical ventilation\n* No contraindication to receipt of fentanyl or dexmedetomidine per clinician judgment\n* Availability and willingness of the parent/legal guardian to provide written informed consent\n\nExclusion Criteria:\n\n* Any concomitant condition, which in the opinion of the investigator would preclude a subject's participation in the study.\n* Previous participation in this study\n* Planned receipt of sedatives other than fentanyl or dexmedetomidine\n* Participants with any of the following diagnoses: traumatic brain injury, intracranial hemorrhage, baseline neurodevelopmental delay, status epilepticus, or requiring inotropic support for hemodynamic stability.\n* Renal failure requiring renal replacement therapy\n* Hepatic failure\n* Support with extracorporeal membrane oxygenation"}, 'identificationModule': {'nctId': 'NCT03293927', 'briefTitle': 'Polypharmacy-related Adverse Events in Critically Ill Children', 'organization': {'class': 'OTHER', 'fullName': 'Duke University'}, 'officialTitle': 'Investigating Polypharmacy-related Adverse Events in Critically Ill Children', 'orgStudyIdInfo': {'id': 'Pro00084476'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Fentanyl + Dexmedetomidine', 'interventionNames': ['Drug: Fentanyl', 'Drug: Dexmedetomidine']}, {'type': 'EXPERIMENTAL', 'label': 'Dexmedetomidine + Fentanyl', 'interventionNames': ['Drug: Fentanyl', 'Drug: Dexmedetomidine']}, {'type': 'EXPERIMENTAL', 'label': 'Fentanyl only', 'interventionNames': ['Drug: Fentanyl']}, {'type': 'EXPERIMENTAL', 'label': 'Dexmedetomidine only', 'interventionNames': ['Drug: Dexmedetomidine']}], 'interventions': [{'name': 'Fentanyl', 'type': 'DRUG', 'description': 'The patient will receive IV fentanyl', 'armGroupLabels': ['Dexmedetomidine + Fentanyl', 'Fentanyl + Dexmedetomidine', 'Fentanyl only']}, {'name': 'Dexmedetomidine', 'type': 'DRUG', 'description': 'The patient will receive IV dexemedetomidine', 'armGroupLabels': ['Dexmedetomidine + Fentanyl', 'Dexmedetomidine only', 'Fentanyl + Dexmedetomidine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke University Medical Center', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}], 'overallOfficials': [{'name': 'Kanecia Zimmerman, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Duke'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Duke University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}