Ignite Creation Date:
2025-12-25 @ 3:47 AM
Ignite Modification Date:
2025-12-26 @ 2:34 AM
Study NCT ID:
NCT01152502
Status:
COMPLETED
Last Update Posted:
2010-06-29
First Post:
2010-06-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Paracetamol Metabolism in Post Operative Conditions
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-06', 'completionDateStruct': {'date': '2010-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-06-28', 'studyFirstSubmitDate': '2010-06-28', 'studyFirstSubmitQcDate': '2010-06-28', 'lastUpdatePostDateStruct': {'date': '2010-06-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-06-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Follow-up of urinary concentration from paracetamol metabolites by patients with aortic surgery during 4 days therapeutic intake (perfalgan ® 4 x 1g IV/day)', 'timeFrame': 'during 4 days therapeutic intake'}], 'secondaryOutcomes': [{'measure': '- Follow-up of glutathion concentration during 4 post operative days', 'timeFrame': 'during 4 post operative days'}, {'measure': 'Monitoring of liver function'}]}, 'conditionsModule': {'keywords': ['Post operative conditions, paracetamol metabolites'], 'conditions': ['Aortic Surgery and Treatment Post Operative With Paracetamol During 4 Days']}, 'descriptionModule': {'briefSummary': 'Follow-up of urinary concentration from paracetamol metabolites by patients with aortic surgery during 4 days therapeutic intake (perfalgan ® 4 x 1g IV/day)', 'detailedDescription': 'D-15 to D0: selection\n\n* patient information and non-opposition obtained\n* inclusion and non inclusion criteria check\n* clinical exam\n\nD-1 to D0 : 24 hours diuresis\n\nD0 : operation day\n\nBefore anesthesia :\n\n* urine collection (paracetamol metabolites dosage)\n* blood sampling (glutathion and liver function test)\n\nSurgery:\n\n* 1st paracetamol intake before closing\n* Then administration every 6 hours\n\nD1 to D4 :\n\n* 24 hours urine collection (metabolites dosage)\n* blood sampling et D1 and D4(glutathion and liver function test)\n\nD5 : final clinical exam'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Defined population', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* aortic surgery\n* treatment with intraveinous paracetamol (4 grammes daily during 4 days)\n* patient agrees to participate\n\nExclusion Criteria:\n\n* \\- patient disagrees\n* paracetamol contra-indication\n* paracetamol intake 5 days before surgery'}, 'identificationModule': {'nctId': 'NCT01152502', 'briefTitle': 'Paracetamol Metabolism in Post Operative Conditions', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Clermont-Ferrand'}, 'officialTitle': 'Paracetamol Metabolism in Post Operative Conditions', 'orgStudyIdInfo': {'id': 'CHU-0076'}}, 'contactsLocationsModule': {'locations': [{'zip': '63003', 'city': 'Clermont-Ferrand', 'country': 'France', 'facility': 'CHU Clermont-Ferrand', 'geoPoint': {'lat': 45.77969, 'lon': 3.08682}}], 'overallOfficials': [{'name': 'Eric SCHNEIDER', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Clermont-Ferrand'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Clermont-Ferrand', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Patrick LACARIN', 'oldOrganization': 'CHU Clermont-Ferrand'}}}}