Ignite Creation Date:
2025-12-24 @ 4:48 PM
Ignite Modification Date:
2025-12-27 @ 7:13 AM
Study NCT ID:
NCT03787550
Status:
UNKNOWN
Last Update Posted:
2020-02-17
First Post:
2018-11-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
PK/PD of the Sedatives, Analgesics and Antibiotics in Patients Receiving ECMO
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000700', 'term': 'Analgesics'}, {'id': 'D000900', 'term': 'Anti-Bacterial Agents'}], 'ancestors': [{'id': 'D018689', 'term': 'Sensory System Agents'}, {'id': 'D018373', 'term': 'Peripheral Nervous System Agents'}, {'id': 'D045505', 'term': 'Physiological Effects of Drugs'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D002491', 'term': 'Central Nervous System Agents'}, {'id': 'D045506', 'term': 'Therapeutic Uses'}, {'id': 'D000890', 'term': 'Anti-Infective Agents'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 36}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-02-07', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-05', 'completionDateStruct': {'date': '2022-03-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-02-12', 'studyFirstSubmitDate': '2018-11-21', 'studyFirstSubmitQcDate': '2018-12-23', 'lastUpdatePostDateStruct': {'date': '2020-02-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-12-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Minimum Plasma Concentration [Cmin]', 'timeFrame': 'Up to 24 hours.', 'description': 'The minimum plasma concentration (the trough concentration), usually collected before the next dose.'}, {'measure': 'Area Under the Curve [AUC]', 'timeFrame': 'Up to 24 hours.', 'description': 'The area under the curve during the dose interval. It also can be calculated by the dose and the clearance of the drug.'}, {'measure': 'Maximum Plasma Concentration [Cmax]', 'timeFrame': 'Up to 24 hours.', 'description': 'The maximum plasma concentration, usually at the end of the infusion during an dose interval.'}], 'secondaryOutcomes': [{'measure': 'ICU mortality', 'timeFrame': 'Up to 60 days.', 'description': 'The intensive care unit (ICU) mortality is calculated as the number of deaths of the enrolled patients admitted to the ICU, divided by the number of the enrolled patient discharges from the ICU (including deaths and transfers), and often presented as percentage.'}, {'measure': 'Hospital mortality', 'timeFrame': 'Up to 60 days.', 'description': 'The hospital mortality is calculated as the number of deaths of the enrolled patients divided by the number of the total enrolled patient, and often presented as percentage.'}, {'measure': 'Mechanical ventilation duration', 'timeFrame': 'Up to 60 days.', 'description': 'Mechanical ventilation duration is the length of days the patients on the mechanical ventilation.'}, {'measure': 'ICU length of stay (LOS)', 'timeFrame': 'Up to 60 days.', 'description': 'ICU length of stay (LOS) is the length of days the patients in the ICU.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['ECMO', 'Sedatives', 'Analgesics', 'Antibiotics'], 'conditions': ['Drug Effect']}, 'descriptionModule': {'briefSummary': 'It is a multi-center, open-label, observational study aimed to understand the pharmacokinetics and pharmacodynamics of the commonly used sedative, analgesic and antibiotic drugs in adult patients supported with extracorporeal membrane oxygenation (ECMO), by measuring the plasma concentrations and the clinical effect of dexmedetomidine, midazolam, butorphanol, remifentanil, sufentanil, propofol, linezolid, tigecycline, teicoplanin, caspofungin, voriconazole and meropenem.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The patients undergoing ECMO will be invited to participate. At least 2-12 subjects will be enrolled to build a pharmacokineic model for each drug, and 1-4 subjects for external validation for each drug. The investigators plan to study the sedatives, analgesics and antibiotics with the initial sample size at 36 in total.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient given the sedatives, analgesics and antibiotics of interest during ECMO.\n* Age from 18 to 85 years old.\n* Multiple blood sampling is acceptable.\n\nExclusion Criteria:\n\n* Patients who are allergic to the investigated drugs.\n* Patients who are pregnant.'}, 'identificationModule': {'nctId': 'NCT03787550', 'briefTitle': 'PK/PD of the Sedatives, Analgesics and Antibiotics in Patients Receiving ECMO', 'organization': {'class': 'OTHER', 'fullName': "Guangdong Provincial People's Hospital"}, 'officialTitle': 'Pharmacokinetics/Pharmacodynamics of the Sedatives, Analgesics and Antibiotics in Patients Receiving Extracorporeal Membrane Oxygenation (ECMO)', 'orgStudyIdInfo': {'id': 'ECMO001'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Model building group', 'description': 'The data from the patients in the model building group will be used to build the population PK/PD model. Two to six blood samples will be collected during at least one dose interval at the steady-state, including one sample from the start of ECMO and one at the end of ECMO.', 'interventionNames': ['Drug: The Sedatives, analgesics and antibiotics']}, {'label': 'Model validation group', 'description': 'The data from the patients in the model building group will be used to build the population PK/PD model. Two to three blood samples will be collected during at least one dose interval at the steady-state, including one sample from the start of ECMO and one at the end of ECMO.', 'interventionNames': ['Drug: The Sedatives, analgesics and antibiotics']}], 'interventions': [{'name': 'The Sedatives, analgesics and antibiotics', 'type': 'DRUG', 'description': 'The sedatives (dexmedetomidine, midazolam, propofol), analgesics (butorphanol, remifentanil, sufentanil), and six antibiotics (linezolid, voriconazole, tigecycline, teicoplanin, caspofungin and meropenem) will be used according to the clinical need.', 'armGroupLabels': ['Model building group', 'Model validation group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510080', 'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Chunbo Chen, Ph.D.', 'role': 'CONTACT'}, {'name': 'Xipei Wang, Ph.D.', 'role': 'CONTACT', 'email': 'xipei_wang@163.com'}], 'facility': "Guangdong Provincial People's Hospital", 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'facility': "Guangzhou First People's Hospital", 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'facility': 'Nanfang Hospital', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}], 'centralContacts': [{'name': 'Chunbo Chen, Ph. D.', 'role': 'CONTACT', 'email': 'gghccm@163.com', 'phone': '+86-20-83827812', 'phoneExt': '51157'}, {'name': 'Xipei Wang, Ph. D.', 'role': 'CONTACT', 'email': 'xipei_wang@163.com', 'phone': '+86-20-83827812', 'phoneExt': '51157'}], 'overallOfficials': [{'name': 'Chunbo Chen, Ph. D.', 'role': 'STUDY_CHAIR', 'affiliation': 'Guandong General Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Guangdong Provincial People's Hospital", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}