Ignite Creation Date:
2025-12-25 @ 1:11 AM
Ignite Modification Date:
2026-01-06 @ 11:59 AM
Study NCT ID:
NCT03216993
Status:
UNKNOWN
Last Update Posted:
2018-04-17
First Post:
2017-07-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An Early Enteral Nutrition Protocol in Shanghai
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016638', 'term': 'Critical Illness'}], 'ancestors': [{'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D059039', 'term': 'Standard of Care'}, {'id': 'C085068', 'term': 'CARE protocol'}], 'ancestors': [{'id': 'D019984', 'term': 'Quality Indicators, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 400}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2018-12-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-04', 'completionDateStruct': {'date': '2021-10-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-04-16', 'studyFirstSubmitDate': '2017-07-08', 'studyFirstSubmitQcDate': '2017-07-12', 'lastUpdatePostDateStruct': {'date': '2018-04-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-07-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'energy target fulfilling rate', 'timeFrame': '7 days from enrollment', 'description': 'the proportion of patients in both arms meeting the targeted energy in-take'}, {'measure': 'protein target fulfilling rate', 'timeFrame': '7 days from enrollment', 'description': 'the proportion of patients in both arms meeting the targeted protein in-take'}], 'secondaryOutcomes': [{'measure': 'mortality', 'timeFrame': '28 days from enrollment', 'description': 'mortality'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['feeding protocol'], 'conditions': ['Critical Illness', 'Enteral Feeding Intolerance']}, 'descriptionModule': {'briefSummary': 'compare different enteral nutrition strategy in patients with mechanical ventilation', 'detailedDescription': 'There has been many evidence that deficiency in energy and protein take-in are associated with poor outcome in critical patients. To reach an adequate amount of energy and protein is critical in patients with respiratory failure and with mechanical ventilation, as it prevents muscle dystrophy and thus prevents ICU acquired weakness, leading to a better outcome in the end. Enteral Nutrition is preferred as it prevents gut dysfunction in respiratory failure patients, and may prevent further infection. But there are many challenge in implement a good enteral nutrition therapy, and energy or protein deficiency is common in patient with respiratory failure. There have been many protocols aiming at reaching enough enteral nutrition for ICU patients, most of which are based on a background of western and developed countries. The investigators developped a enteral nutrition protocol based on an unique cultural background of eastern developing country, trying to help the ICU patients reaching nutrition target, so that the patients may have better outcome.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ICU patients\n* Receiving mechanical ventilation (MV) both Non-invasive ventilation and invasive ventilation\n* Expecting MV more than 72 hours\n\nExclusion Criteria:\n\n* Pregnancy\n* ICU stay \\< 72hr'}, 'identificationModule': {'nctId': 'NCT03216993', 'briefTitle': 'An Early Enteral Nutrition Protocol in Shanghai', 'organization': {'class': 'OTHER', 'fullName': 'Ruijin Hospital'}, 'officialTitle': 'The Shanghai Protocol for Early Enteral Nutrition in Mechanical Ventilated Patients', 'orgStudyIdInfo': {'id': 'Shanghai EEN'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Standard care', 'description': 'Standard care: patients receive enteral nutrition in accordance with the usual practice in the participating units', 'interventionNames': ['Other: Standard care']}, {'type': 'EXPERIMENTAL', 'label': 'Protocol care', 'description': 'Protocol care： patient receive enteral nutrition in accordance with enteral nutrition protocol studied', 'interventionNames': ['Other: Protocol care']}], 'interventions': [{'name': 'Standard care', 'type': 'OTHER', 'description': 'Standard care: patients receive enteral nutrition in accordance with the usual practice in the participating units', 'armGroupLabels': ['Standard care']}, {'name': 'Protocol care', 'type': 'OTHER', 'description': 'Protocol care： patient receive enteral nutrition in accordance with enteral nutrition protocol studied', 'armGroupLabels': ['Protocol care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20000', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Ruijin', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Hongping Qu, Doctor', 'role': 'CONTACT', 'email': 'qhp10516@rjh.com.cn', 'phone': '+8618917762330'}, {'name': 'Ming Zhong, Master', 'role': 'CONTACT', 'email': 'zm11716@rjh.com.cn', 'phone': '+8613564626325'}], 'overallOfficials': [{'name': 'Zhen Er Chen, Doctor', 'role': 'STUDY_CHAIR', 'affiliation': 'Ruijin Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ruijin Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Erzhen Chen', 'investigatorAffiliation': 'Ruijin Hospital'}}}}