Ignite Creation Date:
2025-12-25 @ 2:32 AM
Ignite Modification Date:
2026-01-04 @ 4:38 PM
Study NCT ID:
NCT05115734
Status:
RECRUITING
Last Update Posted:
2023-06-27
First Post:
2021-10-30
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Acylcarnitine Profile After Intensive Care
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-11-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2026-01-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-06-25', 'studyFirstSubmitDate': '2021-10-30', 'studyFirstSubmitQcDate': '2021-10-30', 'lastUpdatePostDateStruct': {'date': '2023-06-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-11-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Acylcarnitine profile', 'timeFrame': 'During the 5 first days following ICU discharge', 'description': 'Serum acylcarnitine profile'}, {'measure': 'Acylcarnitine profile', 'timeFrame': '1 month following ICU discharge', 'description': 'Serum acylcarnitine profile in long stayers'}, {'measure': 'Acylcarnitine profile', 'timeFrame': '3 month following ICU discharge', 'description': 'Serum acylcarnitine profile in long stayers'}, {'measure': 'Acylcarnitine profile', 'timeFrame': '12 month following ICU discharge', 'description': 'Serum acylcarnitine profile in long stayers'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Critical Care', 'Carnitine Metabolism Disturbances']}, 'descriptionModule': {'briefSummary': 'The aim of the study is to compare the acylcarnitine profile of critically ill survivors of a prolonged stay in ICU with the profile of survivors of short ICU length of stay. The second aim is to assess the evolution of the acylcarnitine profile over time in survivors of a prolonged ICU stay.', 'detailedDescription': 'In a retrospective analysis focused on survivors of an ICU stay of 7 days or more, we showed that during the week following discharge, carnitine deficiency was rare, but acylcarnitine profile was altered, with an abnormal acylcarnitine/carnitine ratio in more than 25% of the population.\n\nCarnitine has a key role in cellular energy metabolism and is a a biomarker of the mitochondria function. Moreover, mitochondrial function is proven to be severely impaired in critically ill patients and mitochondrial dysfunction has been linked to post-ICU disorders.\n\nIn this context, it is relevant to study the evolution over time of the acylcarnitine profile in ICU survivors of a prolonged ICU stay. It is also relevant to compare the same profile between survivors of a prolonged and a shorter ICU stay.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '* Group short stayers: Critically ill patients with ICU length of stay of 2 days: patients admitted in ICU after a scheduled cardiac surgery with sternotomy\n* Group long stayers: Critically ill patients with ICU length of stay of at least 7 days, whatever the critically illness', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Group short stayers: ICU length of stay of 2 days\n* Group long stayers: ICU length of stay of at least 7 days\n\nExclusion criteria: patient refusal'}, 'identificationModule': {'nctId': 'NCT05115734', 'briefTitle': 'Acylcarnitine Profile After Intensive Care', 'organization': {'class': 'OTHER', 'fullName': 'University of Liege'}, 'officialTitle': 'Acylcarnitine Profile After Intensive Care', 'orgStudyIdInfo': {'id': 'CARNUSI'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Short stayers', 'description': 'Determination of the acylcarnitine profile during the 5 days following discharge of a short stay in ICU (maximum 2 days)', 'interventionNames': ['Diagnostic Test: Serum acylcarnitine profiling']}, {'label': 'Long stayers', 'description': 'Determination of the acylcarnitine profile during the year following discharge of a prolonged stay in ICU (7 days or more)', 'interventionNames': ['Diagnostic Test: Serum acylcarnitine profiling']}], 'interventions': [{'name': 'Serum acylcarnitine profiling', 'type': 'DIAGNOSTIC_TEST', 'description': 'Blood samples are collected through a central or peripheral venous line placed for clinical use, or through venous punction. Blood will be drawn into a serum gel tube (BD Vacutainer, Becton, Dickinson and Company, Franklin Lakes, NJ, USA), before being centrifuged (3500 rpm, 15 min, 4°C). Supernatant will be frozen at -20°C and stored for later analysis.\n\nSerum ACs concentrations (free carnitine (C0), C2-, C3-, C3DC-, C4-, C4-OH-, C4-DC-, C5-, C5:1-, C5-OH-, C5DC-, C6-, C6-OH-, C6-DC-, C8-, C8:1-, C10-, C10:1-, C10:2-, C12-, C12:1-, C14-, C14:1-, C14:2-, C14-OH-, C16-, C16:1-, C16-OH-, C16-1-OH-, C17-, C18- ,C18:1-, C18:2-, C18-OH-, C18:1-OH-, C18:2-OH-carnitine) will be determined on a TQ5500 tandem mass spectrometer (Sciex, Framingham, MA, USA).', 'armGroupLabels': ['Long stayers', 'Short stayers']}]}, 'contactsLocationsModule': {'locations': [{'zip': '4000', 'city': 'Liège', 'status': 'RECRUITING', 'country': 'Belgium', 'contacts': [{'name': 'Anne-Françoise Rousseau, PhD', 'role': 'CONTACT', 'email': 'afrousseau@chuliege.be', 'phone': '+3243667495'}], 'facility': 'University Hospital of Liège', 'geoPoint': {'lat': 50.63373, 'lon': 5.56749}}], 'centralContacts': [{'name': 'Anne-Françoise Rousseau, MD, PhD', 'role': 'CONTACT', 'email': 'afrousseau@chuliege.be', 'phone': '+3243667495'}, {'name': 'François Boemer, PhD', 'role': 'CONTACT', 'email': 'f.boemer@chuliege.be'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Liege', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of Clinic', 'investigatorFullName': 'Anne-Françoise Rousseau', 'investigatorAffiliation': 'University of Liege'}}}}