Ignite Creation Date:
2025-12-24 @ 9:55 PM
Ignite Modification Date:
2026-02-21 @ 2:37 AM
Study NCT ID:
NCT02716532
Status:
COMPLETED
Last Update Posted:
2018-01-29
First Post:
2016-03-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bioavailability of Medium Chain Triglycerides (MCTs) in Comatose Patients With Acute Brain Injury (ABI)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001930', 'term': 'Brain Injuries'}, {'id': 'D013345', 'term': 'Subarachnoid Hemorrhage'}], 'ancestors': [{'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D006259', 'term': 'Craniocerebral Trauma'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D020300', 'term': 'Intracranial Hemorrhages'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 17}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-01', 'completionDateStruct': {'date': '2017-11-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-01-25', 'studyFirstSubmitDate': '2016-03-17', 'studyFirstSubmitQcDate': '2016-03-17', 'lastUpdatePostDateStruct': {'date': '2018-01-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-03-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-05-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes from Baseline of plasma and brain extracellular (CMD fluid) levels of MCFAs and KBs in sTBI upon Peptamen AF nutritional support', 'timeFrame': 'Over 7 days'}], 'secondaryOutcomes': [{'measure': 'Changes from baseline of plasma and brain extracellular levels of MCFAs and KBs in aSAH patients', 'timeFrame': 'After at least 2 consecutive days of stable enteral nutrition'}, {'measure': 'Change from baseline in plasma and brain extracellular levels of MCFAs and KBs in all patients', 'timeFrame': 'Over 7 days (not necessarily at stable EN).'}, {'measure': 'As part of standard care, monitoring of intra-cerebral physiologic and metabolic variables and correlation with brain MCFAs and KBs levels in all patients', 'timeFrame': 'Over 7 days'}, {'measure': 'Changes from baseline in cerebrospinal fluid of MCFAs and KBs concentrations in all patients with extra-ventricular drainage (EVD) as part of standard care', 'timeFrame': 'Over 7 days'}, {'measure': 'To correlate MCFAs and KBs levels in CMD, plasma and cerebral spinal fluid in all patients', 'timeFrame': 'Over 7 days'}, {'measure': 'Evaluation of the time to reach two days of stable nutrition in all patients', 'timeFrame': 'Over 7 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Injuries, Acute Brain', 'Severe Trauma Brain Injury (sTBI)', 'Subarachnoid Hemorrhage, Aneurysmal']}, 'descriptionModule': {'briefSummary': 'This study will be targeting patients suffering from acute brain injury (ABI), including those with severe trauma brain injury (sTBI) and those with aneurysmal sub arachnoid hemorrhage (aSAH).\n\nThis clinical study is an open-label, non-randomized, single-center, exploratory metabolic study.\n\nThe primary objective is to determine changes from baseline (before enteral administration of Peptamen AF) in plasma and brain extracellular levels of MCFAs and Ketone bodies in sTBI patients upon Peptamen AF nutritional support.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Comatose patients (defined by an initial Glasgow Coma Scale (GCS) \\< 9) following sTBI or aSAH.\n* Female or male, aged \\>18.\n* Abnormal head CT-Scan (contusions, hematoma).\n* Intracranial monitoring with CMD, \\[PbtO2\\] and \\[ICP\\] probes as part of standard of care.\n* Written informed consent from an independent physician (not associated to the research project) who provides medical follow-up and defends patient's interests.\n* Written informed consent from patient relative/legal representative confirming the presumed patient willingness to participate in the study\n\nExclusion Criteria:\n\n* Signs of brain death or expected brain death within 48h.\n* Pregnancy.\n* Hemodynamic instability (circulatory shock, requiring vasopressors).\n* Renal or liver insufficiency .\n* Chronic intestinal disease.\n* Patients requiring parenteral nutrition .\n* Currently participating or having participated in another clinical trial during the month preceding the study"}, 'identificationModule': {'nctId': 'NCT02716532', 'acronym': 'MCTs and ABI', 'briefTitle': 'Bioavailability of Medium Chain Triglycerides (MCTs) in Comatose Patients With Acute Brain Injury (ABI)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Société des Produits Nestlé (SPN)'}, 'officialTitle': 'Bioavailability of Medium Chain Triglycerides (MCTs) in Comatose Patients With Acute Brain Injury (ABI)', 'orgStudyIdInfo': {'id': '15.03.CLI'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Peptamen AF', 'description': 'over 7 days', 'interventionNames': ['Dietary Supplement: Peptamen AF']}], 'interventions': [{'name': 'Peptamen AF', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Each patient will receive Peptamen AF throughout the trial.', 'armGroupLabels': ['Peptamen AF']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1011', 'city': 'Lausanne', 'country': 'Switzerland', 'facility': 'Department of Intensive Care Medicine CHUV', 'geoPoint': {'lat': 46.516, 'lon': 6.63282}}], 'overallOfficials': [{'name': 'Bernard Cuénoud, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Nestec SA'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Société des Produits Nestlé (SPN)', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}