Ignite Creation Date:
2025-12-24 @ 10:35 PM
Ignite Modification Date:
2025-12-28 @ 4:49 AM
Study NCT ID:
NCT01531335
Status:
COMPLETED
Last Update Posted:
2015-12-11
First Post:
2012-02-07
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Hypocaloric Nutrition in Critically Ill Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': True, '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'}], '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'rujeles@javeriana.edu.co', 'phone': '5715946161', 'title': 'Dr Saul Rugeles', 'phoneExt': '2240', 'organization': 'Pontificia Universidad Javeriana'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'No surgical patients included Wide variety of patients Caloric needs were not estimated with a gold standard'}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Standard Care', 'description': 'Patients will receive normal nutritional regime of around 25 kcal per kg.\n\nStandard care: 25 kcal per kg of body weight', 'otherNumAtRisk': 40, 'otherNumAffected': 0, 'seriousNumAtRisk': 40, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Hypocaloric Hyperproteic Nutrition', 'description': '15 kcal per kg of body weight and 1.7 grams of protein per kg\n\nHypocaloric hyperproteic nutrition: 15 kcal per kg of body weight and 1.7 grams of protein per kg.', 'otherNumAtRisk': 40, 'otherNumAffected': 0, 'seriousNumAtRisk': 40, 'seriousNumAffected': 0}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'SOFA (Sequential Organ Failure Assessment) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard Care', 'description': 'Patients will receive normal nutritional regime of around 25 kcal per kg.\n\nStandard care: 25 kcal per kg of body weight'}, {'id': 'OG001', 'title': 'Hypocaloric Hyperproteic Nutrition', 'description': '15 kcal per kg of body weight and 1.7 grams of protein per kg\n\nHypocaloric hyperproteic nutrition: 15 kcal per kg of body weight and 1.7 grams of protein per kg.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.7', 'spread': '2.8', 'groupId': 'OG000'}, {'value': '1.7', 'spread': '1.9', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '48 hours since nutritional regime starts', 'description': 'SOFA score evaluates six systems: respiratory, cardiovascular, coagulation, Central Nervous System, liver and renal. Each system gets a score from 0 (normal) to 4 (abnormal) and the sum of each score defines the final SOFA score, which 24 is the maximum score (high risk of morality) and 0 is the minimum score (low risk of mortality).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Insulin Requirements', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard Care', 'description': 'Patients will receive normal nutritional regime of around 25 kcal per kg.\n\nStandard care: 25 kcal per kg of body weight'}, {'id': 'OG001', 'title': 'Hypocaloric Hyperproteic Nutrition', 'description': '15 kcal per kg of body weight and 1.7 grams of protein per kg\n\nHypocaloric hyperproteic nutrition: 15 kcal per kg of body weight and 1.7 grams of protein per kg.'}], 'classes': [{'categories': [{'measurements': [{'value': '14', 'spread': '22.1', 'groupId': 'OG000'}, {'value': '10.4', 'spread': '17.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Daily until day 21 or discharge from ICU', 'description': 'This is an indirect measure of glycemic control, and is reported as a daily average.', 'unitOfMeasure': 'International Unit of insulin', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Standard Care', 'description': 'Patients will receive normal nutritional regime of around 25 kcal per kg.\n\nStandard care: 25 kcal per kg of body weight'}, {'id': 'FG001', 'title': 'Hypocaloric Hyperproteic Nutrition', 'description': '15 kcal per kg of body weight and 1.7 grams of protein per kg\n\nHypocaloric hyperproteic nutrition: 15 kcal per kg of body weight and 1.7 grams of protein per kg.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '40'}, {'groupId': 'FG001', 'numSubjects': '40'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '40'}, {'groupId': 'FG001', 'numSubjects': '40'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '80', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Standard Care', 'description': 'Patients will receive normal nutritional regime of around 25 kcal per kg.\n\nStandard care: 25 kcal per kg of body weight'}, {'id': 'BG001', 'title': 'Hypocaloric Hyperproteic Nutrition', 'description': '15 kcal per kg of body weight and 1.7 grams of protein per kg\n\nHypocaloric hyperproteic nutrition: 15 kcal per kg of body weight and 1.7 grams of protein per kg.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '55.7', 'spread': '19.5', 'groupId': 'BG000'}, {'value': '53.3', 'spread': '19.5', 'groupId': 'BG001'}, {'value': '54.5', 'spread': '19.5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '40', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '80', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Colombia', 'categories': [{'measurements': [{'value': '40', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '80', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-11', 'completionDateStruct': {'date': '2012-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-11-07', 'studyFirstSubmitDate': '2012-02-07', 'resultsFirstSubmitDate': '2013-12-16', 'studyFirstSubmitQcDate': '2012-02-08', 'lastUpdatePostDateStruct': {'date': '2015-12-11', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-11-07', 'studyFirstPostDateStruct': {'date': '2012-02-10', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-12-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'SOFA (Sequential Organ Failure Assessment) Score', 'timeFrame': '48 hours since nutritional regime starts', 'description': 'SOFA score evaluates six systems: respiratory, cardiovascular, coagulation, Central Nervous System, liver and renal. Each system gets a score from 0 (normal) to 4 (abnormal) and the sum of each score defines the final SOFA score, which 24 is the maximum score (high risk of morality) and 0 is the minimum score (low risk of mortality).'}], 'secondaryOutcomes': [{'measure': 'Insulin Requirements', 'timeFrame': 'Daily until day 21 or discharge from ICU', 'description': 'This is an indirect measure of glycemic control, and is reported as a daily average.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['adults'], 'conditions': ['Critically Ill']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to compare two nutritional regimes in critically ill patients. Patients will be randomized to standard care (25 kcal per kg) or to hypocaloric nutrition (15 kcal per kg). The main outcome will be the SOFA (sequential organ failure assessment) score. The hypothesis is that hypocaloric hyperproteic diet decreases the incidence of organic failure in these patients.', 'detailedDescription': 'The research site will be the intensive care unit (ICU) of Hospital Universitario San Ignacio; eligible patients will \\>18 years of age with a presumed fasting period of at least 96 hours, with no contraindications for enteral nutrition. Patients with parenteral nutrition, pregnancy, diabetes, liver failure, renal failure, transplant protocol, or admitted from another hospital will be excluded. In all patients, the following information will be collected daily: enteral formula in ml, carbohydrate intake, insulin required (in IU), presence of hyper or hypoglicemia, presence of infections, among others.\n\nThe SOFA score will be assessed every two days until discharge from ICU.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* \\>18 years\n* estimated fasting period of at least 96 hours\n\nExclusion Criteria:\n\n* parenteral nutrition\n* pregnancy\n* diabetes\n* liver or renal failure\n* transplantation\n* admitted from another hospital'}, 'identificationModule': {'nctId': 'NCT01531335', 'acronym': 'RuRaL', 'briefTitle': 'Hypocaloric Nutrition in Critically Ill Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Lafrancol S.A.'}, 'officialTitle': 'Effectiveness of Hypocaloric Nutrition Compared With Standard Care in Critically Ill Adults Patients, a Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'SJ0079'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Standard care', 'description': 'Patients will receive normal nutritional regime of around 25 kcal per kg.', 'interventionNames': ['Dietary Supplement: Standard care']}, {'type': 'EXPERIMENTAL', 'label': 'Hypocaloric hyperproteic nutrition', 'description': '15 kcal per kg of body weight and 1.7 grams of protein per kg', 'interventionNames': ['Dietary Supplement: Hypocaloric hyperproteic nutrition']}], 'interventions': [{'name': 'Hypocaloric hyperproteic nutrition', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Hypocaloric hyperproteic'], 'description': '15 kcal per kg of body weight and 1.7 grams of protein per kg.', 'armGroupLabels': ['Hypocaloric hyperproteic nutrition']}, {'name': 'Standard care', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Isocaloric'], 'description': '25 kcal per kg of body weight', 'armGroupLabels': ['Standard care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '110311', 'city': 'Bogotá', 'state': 'DC', 'country': 'Colombia', 'facility': 'Hospital Universitario San Ignacio', 'geoPoint': {'lat': 4.60971, 'lon': -74.08175}}], 'overallOfficials': [{'name': 'Saul Rugeles, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Pontificia Universidad Javeriana'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Lafrancol S.A.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Hospital Universitario San Ignacio', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}