Ignite Creation Date:
2025-12-24 @ 7:07 PM
Ignite Modification Date:
2025-12-25 @ 4:41 PM
Study NCT ID:
NCT00714857
Status:
COMPLETED
Last Update Posted:
2014-01-03
First Post:
2008-07-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Population Pharmacokinetics of Dexmedetomidine in ICU Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D020927', 'term': 'Dexmedetomidine'}], 'ancestors': [{'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 21}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-01', 'completionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-01-02', 'studyFirstSubmitDate': '2008-07-07', 'studyFirstSubmitQcDate': '2008-07-11', 'lastUpdatePostDateStruct': {'date': '2014-01-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-07-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pharmacokinetic parameters', 'timeFrame': 'Blood samples are taken three times daily for characterizing the pharmacokinetic parameters'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['ICU patients', 'Dexmedetomidine', 'Sedation', 'Judged', 'Attending', 'Physician'], 'conditions': ['Pharmacokinetics']}, 'descriptionModule': {'briefSummary': 'Dexmedetomidine is a new, highly selective and potent alpha2-adrenoreceptor agonist registered for sedation of patients in intensive care units. Although the pharmacokinetics of dexmedetomidine have been studied previously also in an ICU setting, there is no information on the pharmacokinetics of long-lasting (\\>48 hours) dexmedetomidine infusions in humans.\n\nThe aim of this study is to study the pharmacokinetics of long-lasting dexmedetomidine infusions in ICU patients using the population pharmacokinetics approach.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 18 years.\n* Need for dexmedetomidine sedation (determined by the responsible physician).\n* Predicted length of dexmedetomidine sedation ≥ 48 hours.\n* Written informed consent from the patient or the relatives of the participating patient.\n\nExclusion Criteria:\n\n* A previous history of intolerance to the study drug or related compounds and additives.\n* Existing significant haematological, endocrine, metabolic or gastrointestinal disease'}, 'identificationModule': {'nctId': 'NCT00714857', 'acronym': 'Dex-Pop-PK', 'briefTitle': 'Population Pharmacokinetics of Dexmedetomidine in ICU Patients', 'organization': {'class': 'OTHER', 'fullName': 'University of Turku'}, 'officialTitle': 'Population Pharmacokinetics of Dexmedetomidine in ICU Patients', 'orgStudyIdInfo': {'id': 'Dex-Pop-PK'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Patients receiving dexmedetomidine sedation', 'interventionNames': ['Drug: Dexmedetomidine']}], 'interventions': [{'name': 'Dexmedetomidine', 'type': 'DRUG', 'description': 'The patients are given a normal loading dose (10 min infusion at a rate of 3-6 μg/kg/h) of dexmedetomidine followed by continuous infusion of 0.1 - 2.5 μg/kg/h for the period of time the responsible physician finds reasonable.', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'FIN-20521', 'city': 'Turku', 'country': 'Finland', 'facility': 'Turku University Hospital', 'geoPoint': {'lat': 60.45148, 'lon': 22.26869}}], 'overallOfficials': [{'name': 'Timo T Iirola, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Turku University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Turku', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Timo Iirola', 'investigatorAffiliation': 'University of Turku'}}}}