Ignite Creation Date:
2025-12-24 @ 4:46 PM
Ignite Modification Date:
2026-01-02 @ 5:11 AM
Study NCT ID:
NCT00519350
Status:
COMPLETED
Last Update Posted:
2017-02-24
First Post:
2007-08-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Towards a High-fat Feeding Intervention Study: Identification of Markers for Inflammation and Organ Damage
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018746', 'term': 'Systemic Inflammatory Response Syndrome'}, {'id': 'D018805', 'term': 'Sepsis'}], 'ancestors': [{'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012769', 'term': 'Shock'}, {'id': 'D007239', 'term': 'Infections'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001800', 'term': 'Blood Specimen Collection'}], 'ancestors': [{'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'plasma'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-03', 'completionDateStruct': {'date': '2009-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-02-22', 'studyFirstSubmitDate': '2007-08-21', 'studyFirstSubmitQcDate': '2007-08-21', 'lastUpdatePostDateStruct': {'date': '2017-02-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2007-08-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-06', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['SIRS, sepsis and related syndromes'], 'conditions': ['Systemic Inflammatory Response Syndrome', 'Sepsis']}, 'descriptionModule': {'briefSummary': "Patients undergoing major surgery, trauma or burns are prone to develop an exacerbated inflammatory response, which is potentially lethal to the individual. Recently, the researchers' group showed in a rodent model of hemorrhagic shock that high-fat feeding administered before shock attenuates inflammation and reduces intestinal and hepatic damage. In the mechanism that underlies this protective effect, the release of cholecystokinin in gut wall and activation of efferent vagus bundles are crucial events. Before investigating the effect of high-fat nutrition in clinical setting, suitable markers of inflammation and organ damage need to be selected. In this study, blood will be collected in patients undergoing different types of operations. Consequently several markers for inflammation and organ damage will be determined. Hence, suitable parameters for a future high-fat intervention study will be selected."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients in Maastricht University Hospital area undergoing one of selected types of surgery', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* \\> 18 years\n* elective liver / colon / femur surgery\n\nExclusion Criteria:\n\n* Acute inflammation\n* Chronic Obstructive Respiratory Disease\n* Recent history of abdominal pain or diarrhea\n* BMI \\< 18.5\n* Alcohol or Drugs abuses\n* Recent intake of antibiotics'}, 'identificationModule': {'nctId': 'NCT00519350', 'briefTitle': 'Towards a High-fat Feeding Intervention Study: Identification of Markers for Inflammation and Organ Damage', 'organization': {'class': 'OTHER', 'fullName': 'Maastricht University Medical Center'}, 'officialTitle': 'Towards a High-fat Feeding Intervention Study: Identification of Markers for Inflammation and Organ Damage', 'orgStudyIdInfo': {'id': '074016'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'I', 'description': 'Liver surgery', 'interventionNames': ['Procedure: Blood collection']}, {'label': 'II', 'description': 'Colon surgery', 'interventionNames': ['Procedure: Blood collection']}, {'label': 'III', 'description': 'Femur Fracture', 'interventionNames': ['Procedure: Blood collection']}], 'interventions': [{'name': 'Blood collection', 'type': 'PROCEDURE', 'description': 'In arterial or venous lines already present, small amounts of blood will be collected at certain timepoints following operation', 'armGroupLabels': ['I', 'II', 'III']}]}, 'contactsLocationsModule': {'locations': [{'zip': '6229HX', 'city': 'Maastricht', 'state': 'Limburg', 'country': 'Netherlands', 'facility': 'Maastricht University Hospital', 'geoPoint': {'lat': 50.84833, 'lon': 5.68889}}], 'overallOfficials': [{'name': 'Jan-Willem Greve, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Maastricht University Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Maastricht University Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Jan-Willem Greve', 'oldOrganization': 'University Hospital Maastricht'}}}}