Ignite Creation Date:
2025-12-25 @ 12:05 AM
Ignite Modification Date:
2026-01-05 @ 8:06 PM
Study NCT ID:
NCT03365258
Status:
UNKNOWN
Last Update Posted:
2020-02-07
First Post:
2017-11-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Applying Modified NUTRIC Scoring System to Evaluate the Nutrition Risk and Giving Different Types of Nutritional Support on Clinical Outcomes in Critically Ill Patients
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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-12-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2020-05-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-02-05', 'studyFirstSubmitDate': '2017-11-28', 'studyFirstSubmitQcDate': '2017-12-02', 'lastUpdatePostDateStruct': {'date': '2020-02-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-12-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-05-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'In-hospital mortality', 'timeFrame': '90 days', 'description': 'mortality or discharge'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Critical Illness']}, 'descriptionModule': {'briefSummary': 'Malnutrition is very common in critically ill patients. It is quite important to evaluate nutritional status precisely. Heyland et al firstly reported NUTRIC score including age, APACHE II score, SOFA score, number of commorbidities, days from hospital to ICU admission and IL-6. Because the IL-6 is not routinely checked at ICU. A modified NUTRIC score without IL-6 is more practical. Previous studies showed lower in-hospital mortality in higher nutritional risk patients with higher caloric intake compared with lower caloric intake. However, there is still controversial regarding the in-hospital mortality between full caloric feeding and permissive underfeeding in critically ill patients. Herein the investigators conduct a study to investigate what kinds of nutritional supplements will decrease in-hospital mortality in different nutritional risk patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 1\\. Medical intensive care unit patients 2. age elder than 20 years old 3. Intubated with ventilator support patients 4. Predicted ICU stay longer than 72 hours\n\nExclusion Criteria:\n\n* 1\\. NPO patients 2. Contraindication for enteral feeding 3. TPN use 4. Upper or lower GI bleeding patients 5. Feeding with gastrostomy or Jejunostomy patients 6. Metoclopramide related EPS or Torsades de pointes history'}, 'identificationModule': {'nctId': 'NCT03365258', 'briefTitle': 'The Effect of Applying Modified NUTRIC Scoring System to Evaluate the Nutrition Risk and Giving Different Types of Nutritional Support on Clinical Outcomes in Critically Ill Patients', 'organization': {'class': 'OTHER', 'fullName': 'Taichung Veterans General Hospital'}, 'officialTitle': 'The Effect of Applying Modified NUTRIC Scoring System to Evaluate the Nutrition Risk and Giving Different Types of Nutritional Support on Clinical Outcomes in Critically Ill Patients', 'orgStudyIdInfo': {'id': 'CF17249A'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'High Nutritional Risk', 'description': 'modified NUTRIC score ≥ 5', 'interventionNames': ['Dietary Supplement: Trophic feeding', 'Dietary Supplement: volume-based feeding']}, {'type': 'OTHER', 'label': 'Low Nutritional Risk', 'description': 'modified NUTRIC score \\< 5', 'interventionNames': ['Dietary Supplement: Trophic feeding', 'Dietary Supplement: volume-based feeding']}], 'interventions': [{'name': 'Trophic feeding', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Non-blind to randomize to trophic feeding group and volume based feeding group in the first six days (Day 0-\\>Day 6). The definition of trophic feeding is continue feeding with feeding rate: 20 kcal/hr.', 'armGroupLabels': ['High Nutritional Risk', 'Low Nutritional Risk']}, {'name': 'volume-based feeding', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Full caloric feeding'], 'description': 'Non-blind to randomize to trophic feeding group and volume based feeding group in the first six days (Day 0-\\>Day 6). The definition Volume-based feeding also use continue feeding by feeding protocol', 'armGroupLabels': ['High Nutritional Risk', 'Low Nutritional Risk']}]}, 'contactsLocationsModule': {'locations': [{'zip': '433', 'city': 'Taichung', 'state': '台中市', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': '振宇 王, MD', 'role': 'CONTACT', 'email': 'chestmen@gmail.com', 'phone': '886-4-23592525', 'phoneExt': '3167'}, {'name': 'CHEN-YU WANG, MD', 'role': 'CONTACT', 'email': 'chestmen@gmail.com', 'phone': '886-4-23592525', 'phoneExt': '3167'}], 'facility': '王振宇', 'geoPoint': {'lat': 24.1469, 'lon': 120.6839}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Taichung Veterans General Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director of Medical Intensive Care Unit', 'investigatorFullName': 'Wang, Chen-Yu', 'investigatorAffiliation': 'Taichung Veterans General Hospital'}}}}