Ignite Creation Date:
2025-12-24 @ 10:40 PM
Ignite Modification Date:
2026-02-25 @ 6:56 PM
Study NCT ID:
NCT01760135
Status:
UNKNOWN
Last Update Posted:
2013-01-04
First Post:
2012-12-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Nutritional Requirement for the Severe Trauma Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D006943', 'term': 'Hyperglycemia'}], 'ancestors': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 61}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2012-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-01', 'completionDateStruct': {'date': '2013-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2013-01-03', 'studyFirstSubmitDate': '2012-12-21', 'studyFirstSubmitQcDate': '2013-01-03', 'lastUpdatePostDateStruct': {'date': '2013-01-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-01-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Duration of antibiotics usage (days)', 'timeFrame': 'participants will be followed for the duration of hospital stay, an expected average of 2 week).'}], 'secondaryOutcomes': [{'measure': 'Mortality', 'timeFrame': 'participants will be followed for the duration of hospital stay, an expected average of 2 week'}, {'measure': 'Number of date when is showing hyperglycemia (more than 200mg/dL)', 'timeFrame': 'participants will be followed for the duration of hospital stay, an expected average of 2 week'}, {'measure': 'Hospitals stays', 'timeFrame': 'participants will be followed for the duration of hospital stay, an expected average of 2 week'}, {'measure': 'ICU stays', 'timeFrame': 'participants will be followed for the duration of hospital stay, an expected average of 2 week'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['trauma', 'nutrition', 'hyperglycemia'], 'conditions': ['Trauma']}, 'descriptionModule': {'briefSummary': 'After severe trauma, high caloric nutrition supplement do harm on metabolic and immunologic aspects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ISS more than 15 score\n* older than 20 years old\n* patient who need parenteral nutrition more than 5 days\n\nExclusion Criteria:\n\n* patients who have metabolic disease except for diabetes\n* patients who cannot resuscitated\n* very low body weight (\\< 40kg)'}, 'identificationModule': {'nctId': 'NCT01760135', 'briefTitle': 'Nutritional Requirement for the Severe Trauma Patients', 'organization': {'class': 'OTHER', 'fullName': 'Asan Medical Center'}, 'officialTitle': 'Nutritional Requirement for the Severe Trauma Patients', 'orgStudyIdInfo': {'id': '2012-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'low calory', 'description': '15kcal/kg caloric supplement', 'interventionNames': ['Dietary Supplement: high caloric nutritional supplement']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'high calory', 'description': '25kcal/kg', 'interventionNames': ['Dietary Supplement: low caloric nutritional supplement']}], 'interventions': [{'name': 'high caloric nutritional supplement', 'type': 'DIETARY_SUPPLEMENT', 'description': 'high caloric nutritional supplement (25kcal/kg)', 'armGroupLabels': ['low calory']}, {'name': 'low caloric nutritional supplement', 'type': 'DIETARY_SUPPLEMENT', 'description': 'low caloric nutritional supplement(15kcal/kg)', 'armGroupLabels': ['high calory']}]}, 'contactsLocationsModule': {'locations': [{'zip': '138-736', 'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Suk-Kyung Hong, MD., PhD.', 'role': 'CONTACT', 'email': 'skhong94@amc.seoul.kr', 'phone': '82-2-3010-5989'}], 'facility': 'Asan Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'Suk-Kyung Hong, MD., PhD.', 'role': 'CONTACT', 'email': 'skhong94@amc.seoul.kr', 'phone': '82-2-3010-5989'}], 'overallOfficials': [{'name': 'Suk-Kyung Hong, MD, PhD.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Asan Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Asan Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director, Surgical Intensive Care Unit', 'investigatorFullName': 'Suk-Kyung', 'investigatorAffiliation': 'Asan Medical Center'}}}}