Ignite Creation Date:
2025-12-24 @ 5:38 PM
Ignite Modification Date:
2026-02-26 @ 4:14 PM
Study NCT ID:
NCT03060668
Status:
COMPLETED
Last Update Posted:
2022-03-16
First Post:
2017-02-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Optimized Caloric-proteic Nutrition 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': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 138}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-02', 'completionDateStruct': {'date': '2018-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-03-14', 'studyFirstSubmitDate': '2017-02-11', 'studyFirstSubmitQcDate': '2017-02-21', 'lastUpdatePostDateStruct': {'date': '2022-03-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-02-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'PCS of SF-36', 'timeFrame': '6 months after randomization', 'description': 'Physical component summary of Short Form 36'}], 'secondaryOutcomes': [{'measure': 'Handgrip strength', 'timeFrame': '7th, 14th after admission and up to 30 days', 'description': 'Measured using a calibrated dynamometer'}, {'measure': 'ICU mortality', 'timeFrame': 'Up to 30 days', 'description': 'ICU outcome'}, {'measure': 'Hospital mortality', 'timeFrame': 'Up to 6 months', 'description': 'Hospital outcome'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Critical Illness', 'Indirect Calorimetry', 'Dietary Proteins'], 'conditions': ['Critically Ill']}, 'descriptionModule': {'briefSummary': 'In this prospective randomized controlled trial the investigators intend to compare the use of a nutritional therapy based on caloric intake determined by indirect calorimetry and a high protein intake (2.0 to 2.2 g/kg/day) with a nutritional regimen based on 25 Kcal/kg/day and protein intake usually recommended to critically ill patients (1.4 to 1.5 grams/kg/day).', 'detailedDescription': 'OBJECTIVES\n\nTo evaluate the effect of nutritional therapy with caloric intake determined by indirect calorimetry and high protein intake (2.0 to 2.2 g/kg/day) compared to nutritional therapy with 25 kcal/kg/day and 1.4 to 1, 5 g/kg/day of protein on short-term outcomes and physical component (PCS) of quality of life after 3 and 6 months of randomization in severe ICU patients.\n\nThe primary objective will be the evaluation of the physical component summary (PCS) of SF-36 (Short Form 36), a questionnaire used to evaluate quality of life, validated for the Brazilian population. Patients will be assessed at least 3 and 6 months after randomization.\n\nSecondary objectives: Measurement of handgrip strength measured on the 7th and 14th day of the study and on discharge from the ICU, ICU mortality, hospital mortality, mechanical ventilation time and length of stay in the ICU.\n\nMETHODS\n\nThe study will include patients over 18 years of age, not pregnant, submitted to mechanical ventilation, whose expectation of stay in the ICU is greater than 3 days.\n\nThe sample size was calculated based on the following parameters: patient population under mechanical ventilation, 528, 15% relative risk reduction in the evaluation parameter of the SF-36 tool, Level of significance (α) of 5%, test power of 80%, thus the number of individuals to be sampled will be 294, i.e., two groups of 147 patients. A computer-generated list for randomization and sequentially numbered opaque sealed envelopes is used. The level of significance to reject the null hypothesis will be 5%, that is, a value of p \\<0.05 will be considered as statistically significant.\n\nInformed consent was obtained from the patient or a next of kin.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Critically ill patients Mechanically ventilated Expected length in the ICU \\> 3 days\n\nExclusion Criteria:\n\n* Pregnancy Requirement for inspired oxygen (FIO2) \\> 0.60 High output bronchopleural fistula'}, 'identificationModule': {'nctId': 'NCT03060668', 'briefTitle': 'Optimized Caloric-proteic Nutrition in Critically Ill Patients', 'organization': {'class': 'OTHER', 'fullName': 'Hospital Sao Domingos'}, 'officialTitle': 'Optimized Caloric-proteic Nutrition in Critically Ill Patients: Impact on Short and Long-term Outcomes', 'orgStudyIdInfo': {'id': 'HSaoDomingos'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Study Group', 'description': 'Caloric needs will be determined by indirect calorimetry. Patients in this group will receive 2.0 to 2.2 grams/kg/day of protein.\n\nNutritional therapy will be initiated in the first 24 hours after admission.\n\nNutritional formula will be Peptamen Intense (1.0 kcal/ml, 93 g/L protein (Nestle Health Care).', 'interventionNames': ['Other: Peptamen intense']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control Group', 'description': 'Patients in this group will receive 25 Kcal/kg/day and 1.4 to 1.5 grams/kg/day of protein.\n\nNutritional formula in this group will be Novasource senior (Nestle Health Care).\n\nNutritional therapy will be initiated in the first 24 hours after admission.', 'interventionNames': ['Other: Novasource senior']}], 'interventions': [{'name': 'Peptamen intense', 'type': 'OTHER', 'description': 'Study group will receive a nutritional formula containing 1.0 kcal/ml and 93 g/L of protein', 'armGroupLabels': ['Study Group']}, {'name': 'Novasource senior', 'type': 'OTHER', 'description': 'Control group will receive a nutritional formula containing 1.2 kcal/ml and 65 g/L of protein', 'armGroupLabels': ['Control Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '65060-000', 'city': 'São Luís', 'state': 'Maranhão', 'country': 'Brazil', 'facility': 'Hospital Sao Domingos', 'geoPoint': {'lat': -2.52972, 'lon': -44.30278}}], 'overallOfficials': [{'name': 'JOSE R AZEVEDO, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital Sao Domingos'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital Sao Domingos', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD', 'investigatorFullName': 'José Raimundo Araujo de Azevedo', 'investigatorAffiliation': 'Hospital Sao Domingos'}}}}