Ignite Creation Date:
2025-12-24 @ 11:32 PM
Ignite Modification Date:
2026-02-22 @ 9:05 AM
Study NCT ID:
NCT02159456
Status:
UNKNOWN
Last Update Posted:
2021-08-24
First Post:
2014-06-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Continuous Versus Intermittent Enteral Feeding in Critically Ill Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009748', 'term': 'Nutrition Disorders'}], 'ancestors': [{'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 70}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2014-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'completionDateStruct': {'date': '2021-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-08-18', 'studyFirstSubmitDate': '2014-06-05', 'studyFirstSubmitQcDate': '2014-06-08', 'lastUpdatePostDateStruct': {'date': '2021-08-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-06-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2021-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Achievement rate of target nutritional goal', 'timeFrame': 'Within 7 days after the start of enteral feeding'}], 'secondaryOutcomes': [{'measure': 'Gastrointestinal tolerance', 'timeFrame': 'Within 7 days after start of enteral feeding'}, {'measure': 'ICU/hospital mortality', 'timeFrame': 'During hospital admission'}, {'measure': 'Frequency of hospital-aquired infection', 'timeFrame': 'During hospital admission'}, {'measure': 'ICU/hospital length-of-stay', 'timeFrame': 'During hospital admission'}, {'measure': 'Duration of mechanical ventilation', 'timeFrame': 'During hospital admission'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Nutrition Disorders']}, 'descriptionModule': {'briefSummary': '1. Nutritional support during critical illness is important to improve the clinical outcome of patients. Recently, the apply of early enteral nutrition is recommend in critically ill patients on basis of data that enteral nutrition can be helpful to prevent the hospital-acquired infections.\n\n * However, in critically ill patients, the smooth progress of nutritional support is often hindered by gastrointestinal intolerance, underlying clinical condition, and temporal necessity of procedure or operation.\n * Continuous feeding method, compared with intermittent feeding, is expected to reduce the risk of gastrointestinal intolerance, and improve the nutritional support, but this hypothesis is not supported by appropriate evidences.\n2. We will elucidate to compare the efficacy and safety of the continuous feeding method in critically ill patients, compared with the intermittent feeding method.\n\n * Prospective, randomized controlled study\n * Primary outcome: the achievement rate of target nutritional goal within 7 days after the start of enteral nutrition\n * Secondary outcome: gastrointestinal tolerance, In-ICU/hospital mortality, frequency of hospital-acquired infection, ICU/hospital length-of-stay, duration of mechanical ventilation'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* adult patient admitted in the intensive care unit\n* age 20 years old or more\n* The enteral nutritional support is expected to be available within 48 hours after ICU admission\n\nExclusion Criteria:\n\n* previous abdominal surgery within 1 month\n* gastrointestinal bleeding, bowel obstruction, refractory vomiting/diarrhea\n* hypersensitivity to prokinetics, history of seizure or phechromocytoma\n* enteral feeding via enterostomy or gastrostomy\n* difficulty to insert or maintain nasogastric tube\n* need for specialized feeding (ex: hemodialysis diet, chronic renal failure diet, diabetes diet)\n* pregnancy'}, 'identificationModule': {'nctId': 'NCT02159456', 'briefTitle': 'Continuous Versus Intermittent Enteral Feeding in Critically Ill Patients', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'officialTitle': 'Continuous Versus Intermittent Enteral Feeding in Critically Ill Patients: a Prospective, Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'feed520'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Continuous enteral feeding', 'description': 'Continuous enteral feeding via infusion pump is applied for at least 7 days after the start of enteral feeding', 'interventionNames': ['Other: Continuous enteral feeding via infusion pump']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Intermittent enteral feeding', 'description': 'Intermittent enteral feeding via gravity-based infusion is applied for at least 7 days after the start of enteral feeding.', 'interventionNames': ['Other: Intermittent enteral feeding via gravity-based infusion']}], 'interventions': [{'name': 'Continuous enteral feeding via infusion pump', 'type': 'OTHER', 'armGroupLabels': ['Continuous enteral feeding']}, {'name': 'Intermittent enteral feeding via gravity-based infusion', 'type': 'OTHER', 'armGroupLabels': ['Intermittent enteral feeding']}]}, 'contactsLocationsModule': {'locations': [{'zip': '110-744', 'city': 'Seoul', 'state': 'Daehak-ro, Jongno-gu', 'country': 'South Korea', 'facility': 'Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Jinwoo Lee', 'investigatorAffiliation': 'Seoul National University Hospital'}}}}