Ignite Creation Date:
2025-12-24 @ 3:21 PM
Ignite Modification Date:
2026-01-02 @ 9:41 AM
Study NCT ID:
NCT05406492
Status:
UNKNOWN
Last Update Posted:
2022-06-27
First Post:
2022-06-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Population PK of Antibiotics, Sedative and Analgesics, and Antiplatelet Drugs During ECMO
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Residual whole blood'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10}, 'targetDuration': '10 Days', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-07-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-06', 'completionDateStruct': {'date': '2024-07-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-06-21', 'studyFirstSubmitDate': '2022-06-02', 'studyFirstSubmitQcDate': '2022-06-02', 'lastUpdatePostDateStruct': {'date': '2022-06-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-06-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-07-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pharmacokinetic parameters', 'timeFrame': 'Day 0 to day 3 during ECMO, Day 0 to day 3 after removing ECMO', 'description': 'Volume of distribution'}, {'measure': 'Pharmacokinetic parameters', 'timeFrame': 'Day 0 to day 3 during ECMO, Day 0 to day 3 after removing ECMO', 'description': 'Clearance'}, {'measure': 'Pharmacokinetic parameters', 'timeFrame': 'Day 0 to day 3 during ECMO, Day 0 to day 3 after removing ECMO', 'description': 'Absorption rate (if oral drugs)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Extracorporeal Membrance Oxygenation', 'Pharmacokinetic medeling', 'Antiplatelet agents', 'Sedatives', 'Antibiotics'], 'conditions': ['Pharmacokinetics', 'Extracorporeal Membrane Oxygenation']}, 'referencesModule': {'references': [{'pmid': '22520488', 'type': 'BACKGROUND', 'citation': 'Shekar K, Fraser JF, Smith MT, Roberts JA. Pharmacokinetic changes in patients receiving extracorporeal membrane oxygenation. J Crit Care. 2012 Dec;27(6):741.e9-18. doi: 10.1016/j.jcrc.2012.02.013. Epub 2012 Apr 18.'}, {'pmid': '25032748', 'type': 'BACKGROUND', 'citation': 'Shekar K, Mullany DV, Thomson B, Ziegenfuss M, Platts DG, Fraser JF. Extracorporeal life support devices and strategies for management of acute cardiorespiratory failure in adult patients: a comprehensive review. Crit Care. 2014 May 9;18(3):219. doi: 10.1186/cc13865.'}, {'pmid': '23190792', 'type': 'BACKGROUND', 'citation': 'Shekar K, Roberts JA, Welch S, Buscher H, Rudham S, Burrows F, Ghassabian S, Wallis SC, Levkovich B, Pellegrino V, McGuinness S, Parke R, Gilder E, Barnett AG, Walsham J, Mullany DV, Fung YL, Smith MT, Fraser JF. ASAP ECMO: Antibiotic, Sedative and Analgesic Pharmacokinetics during Extracorporeal Membrane Oxygenation: a multi-centre study to optimise drug therapy during ECMO. BMC Anesthesiol. 2012 Nov 28;12:29. doi: 10.1186/1471-2253-12-29.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to optimize the dosage regimen of drugs in patients during during Extracorporeal Membrane Oxygenation (ECMO) by population pharmacokinetic modeling.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who are taking levofloxacin, meropenem, vancomycin, cefepime, midalzolam, dexmedetomidine, propofol, clopidogrel, ticagrelor, or prasugrel while underdoing Extracorporeal Membrane Oxygenation', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who are taking levofloxacin, meropenem, vancomycin, cefepime, midalzolam, dexmedetomidine, propofol, clopidogrel, ticagrelor, or prasugrel while underdoing Extracorporeal Membrane Oxygenation\n\nExclusion Criteria:\n\n* Pregnant women\n* Receiving a therapy that can affect blood concentration due to a drug-drug interaction with levofloxacin, meropenem, vancomycin, cefepime, midalzolam, dexmedetomidine, propofol, clopidogrel, ticagrelor, or prasugrel'}, 'identificationModule': {'nctId': 'NCT05406492', 'briefTitle': 'Population PK of Antibiotics, Sedative and Analgesics, and Antiplatelet Drugs During ECMO', 'organization': {'class': 'OTHER', 'fullName': 'Gachon University Gil Medical Center'}, 'officialTitle': 'Population Pharmacokinetics of Antibiotics, Sedative and Analgesics, and Antiplatelet Agents During Extracorporeal Membrane Oxygenation (ECMO)', 'orgStudyIdInfo': {'id': 'GDIRB2019-228'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients udergoing ECMO', 'description': 'Population who have been taking antibiotics or antiplatelets or sedatives/analgesics during Extracorporeal Membrane Oxygenation', 'interventionNames': ['Other: Residual blood']}], 'interventions': [{'name': 'Residual blood', 'type': 'OTHER', 'description': 'Residual blood samples(1\\~2 cc) at each sampling time are collected from all subjects while using ECMO for drug concentration assays(LC-MS/MS etc.).', 'armGroupLabels': ['Patients udergoing ECMO']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21565', 'city': 'Incheon', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Jin Wi, Prof', 'role': 'CONTACT', 'email': 'caesar@gilhospital.com', 'phone': '+82 32-460-3663'}], 'facility': 'Gacheon University Gil Medical Center', 'geoPoint': {'lat': 37.45646, 'lon': 126.70515}}], 'centralContacts': [{'name': 'Jin Wi, Prof', 'role': 'CONTACT', 'email': 'caesar@gilhospital.com', 'phone': '+82 32-460-3663'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gachon University Gil Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Yonsei University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director of Heart Intensive Care Unit', 'investigatorFullName': 'Jin Wi', 'investigatorAffiliation': 'Gachon University Gil Medical Center'}}}}