Ignite Creation Date:
2025-12-24 @ 1:29 PM
Ignite Modification Date:
2025-12-30 @ 2:52 AM
Study NCT ID:
NCT05565495
Status:
RECRUITING
Last Update Posted:
2024-08-06
First Post:
2022-09-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effects of ECMO on the Pharmacokinetics of Hydromorphone
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D004091', 'term': 'Hydromorphone'}], 'ancestors': [{'id': 'D009022', 'term': 'Morphine Derivatives'}, {'id': 'D009019', 'term': 'Morphinans'}, {'id': 'D053610', 'term': 'Opiate Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006572', 'term': 'Heterocyclic Compounds, Bridged-Ring'}, {'id': 'D006576', 'term': 'Heterocyclic Compounds, 4 or More Rings'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D010616', 'term': 'Phenanthrenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 26}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2024-09-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-08-05', 'studyFirstSubmitDate': '2022-09-13', 'studyFirstSubmitQcDate': '2022-09-29', 'lastUpdatePostDateStruct': {'date': '2024-08-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-10-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-09-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Volume of distribution of hydromorphone and hydromorphone-3-glucuronide in patients on ECMO', 'timeFrame': 'Within 4 days', 'description': 'Quantitative liquid chromatography-tandem mass spectrometry was used to detect the contents of hydromorphone and hydromorphone -3- glucuronide in blood samples at various time points, so as to obtain the pharmacokinetics of continuous intravenous infusion of hydromorphone for 72 hours during ECMO.'}], 'secondaryOutcomes': [{'measure': 'Clearance of hydromorphone and hydromorphone-3-glucuronide in patients on ECMO', 'timeFrame': 'Within 4 days', 'description': 'Clearance of hydromorphone and hydromorphone-3-glucuronide in patients on ECMO'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Extracorporeal Membrane Oxygenation', 'Pharmacokinetics', 'Hydromorphone'], 'conditions': ['Extracorporeal Membrane Oxygenation']}, 'descriptionModule': {'briefSummary': 'The purpose of this study was to establish a population pharmacokinetic (PPK) model of hydromorphone in patients under ECMO, and to recommend a dosing regimen when the target effective concentration was reached.', 'detailedDescription': 'A population pharmacokinetic (PPK) model of hydromorphone in patients under ECMO was established. The patients were given hydromorphone 0.03mg/kg/h by continuous intravenous infusion for 72 hours for analgesia. Blood samples were collected at different time points before and after administration, and quantitative liquid chromatography tandem mass spectrometry was used to detect hydromorphone and its main metabolite, hydromorphone-3-glucuronide.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Between the ages of 18 and 80;\n* Using hydromorphone for pain relief;\n* Using ECMO for more than 96h\n\nExclusion Criteria:\n\n* Allergic to hydromorphone;\n* Use of CRRT during ECMO;\n* Liver function Child-Pugh B, C grade;\n* Pregnancy;\n* Intestinal obstruction;\n* Refused to sign the informed consent.'}, 'identificationModule': {'nctId': 'NCT05565495', 'briefTitle': 'The Effects of ECMO on the Pharmacokinetics of Hydromorphone', 'organization': {'class': 'OTHER', 'fullName': 'Union Hospital, Tongji Medical College, Huazhong University of Science and Technology'}, 'officialTitle': 'The Effects of ECMO on the Pharmacokinetics of Hydromorphone', 'orgStudyIdInfo': {'id': 'PKHM20210920'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Hydromorphone', 'description': 'Hydromorphone was administered intravenously at a rate of 0.03 mg/kg/h for 72 h for analgesia. Blood samples were collected before administration and at different time points after administration, and the content of hydromorphone and hydromorphone-3-glucuronide (the main metabolite) was detected by quantitative liquid chromatography tandem mass spectrometry. And then a population pharmacokinetic model of hydromorphone in patients under ECMO was established.', 'interventionNames': ['Drug: Hydromorphone']}], 'interventions': [{'name': 'Hydromorphone', 'type': 'DRUG', 'description': 'Hydromorphone was administered intravenously at a rate of 0.03 mg/kg/h for 72 h for analgesia. Blood samples were collected before administration and at different time points after administration, and the contents of hydromorphone and hydromorphone-3-glucuronide (main metabolite) were detected by quantitative liquid chromatography tandem mass spectrometry, and then A population pharmacokinetic model of hydromorphone in patients under ECMO was established.', 'armGroupLabels': ['Hydromorphone']}]}, 'contactsLocationsModule': {'locations': [{'zip': '430022', 'city': 'Wuhan', 'state': 'Hubei', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'You Shang', 'role': 'CONTACT', 'email': 'you_shanghust@163.com', 'phone': '15972127819'}], 'facility': 'Wuhan Union Hospital', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}], 'centralContacts': [{'name': 'You Shang, Prof.', 'role': 'CONTACT', 'email': 'you_shanghust@163.com', 'phone': '008602785351607'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Xiaobo Yang, MD', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Clinical Professor', 'investigatorFullName': 'Xiaobo Yang, MD', 'investigatorAffiliation': 'Union Hospital, Tongji Medical College, Huazhong University of Science and Technology'}}}}