Ignite Creation Date:
2025-12-24 @ 7:19 PM
Ignite Modification Date:
2025-12-30 @ 12:18 PM
Study NCT ID:
NCT04468503
Status:
COMPLETED
Last Update Posted:
2024-06-11
First Post:
2020-07-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparative Effect of Protein Prescription Strategies on Nitrogen Balance and Upshots in Critically Ill Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2024-10-02', 'releaseDate': '2024-06-27'}], 'estimatedResultsFirstSubmitDate': '2024-06-27'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D016638', 'term': 'Critical Illness'}, {'id': 'D044342', 'term': 'Malnutrition'}], 'ancestors': [{'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2022-09-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-06-10', 'studyFirstSubmitDate': '2020-07-03', 'studyFirstSubmitQcDate': '2020-07-08', 'lastUpdatePostDateStruct': {'date': '2024-06-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-07-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Urine Urea Nitrogen (UUN) for Nitrogen Balanace (NB)', 'timeFrame': 'for base line is within 24hours of randomization,for nitrogen balence reassessment every 72 hourly', 'description': 'change in nitrogen balance from baseline.'}, {'measure': 'Readmission in hospital within 30 days of discharge.', 'timeFrame': '30 days after discharge', 'description': 'Patient will be followed for 30 days after discharge from hospital for monitoring, e.g. readmission in hospital Mortality ratio'}], 'secondaryOutcomes': [{'measure': 'Sequential Organ Failure Assessment (SOFA Score)', 'timeFrame': 'up to 72 hours in ICU stay', 'description': "this tool will be use to track a person's status during the stay in an critical care unit (ICU) to determine the extent of a person's organ function or rate of failure, with a minimum SOFA score of 0 (most survival) and a maximum SOFA score of 24(risk of survival)."}, {'measure': 'protein bio markers', 'timeFrame': 'up to 72 hours in ICU stay', 'description': 'Blood Urea Nitrogen, Albumin, C- reactive protien'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['critical illness', 'protein', 'malnutrition'], 'conditions': ['Critical Illness', 'Malnutrition', 'Protein']}, 'referencesModule': {'references': [{'pmid': '40500809', 'type': 'DERIVED', 'citation': 'Bibi Z, Safdar M, Hadayat A. Comparative effect of protein dosage on nitrogen balance and health outcomes in critically ill patients. J Pak Med Assoc. 2025 May;75(5):699-703. doi: 10.47391/JPMA.20753.'}]}, 'descriptionModule': {'briefSummary': 'This is Interventional clinical trail will be conducted in Internationale hospital ICU s patients with higher nutrition risk. two doses of protein 1 g/kg/day Vs 2 g/ kg day will be given and its outcome will be checked on nitrogen balance , clinical outcome length of hospital stay, mortality ratio and re admission within 30 days.', 'detailedDescription': 'STUDY DESIGN This is the prospective interventional randomized controlled trial in which effect of protein prescription on UUN and clinical outcome of critically ill patients enroll in the study will compare The NUTRIC scores will be calculated manually, based on data from the medical records of critically ill patients.This trail will be conducted in three stages.\n\nIn Phase I all admitted patients in critical care unit will be screen by. APACHE II NUTRIC Score Phase II: Patients with nutrition risk will randomly divided into two group (1:1) Interventional Group None Interventional Group Phase III: Follow the patient for 28 days after discharge from Hospital. Study Locale The study will be conducted in the ICUs (SICUs, MICUs, HDU) of Hospital in Islamabad, for this study organizational approval from formal ethical committee will be taken during the time period of six months.\n\nSTATISTICAL METHODS:\n\nDescriptive statistics will be use for demographic data and over all outcomes, further more analytical stat will be used to the type of variables and objective of the study. Z test will be use for the comparison of quantitative variables and Chi square test will be use for categorical data. A NOVA will be use where applicable\n\n.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\nCritically ill patient with nutritional risk Age \\>18 years Pt. ICU stay\\> 48hours\n\nExclusion Criteria:\n\nPatients on ventilator \\> 72 hours \\< 48 hours.' stay in ICU Withdrawal of life support within 7 days of randomization"}, 'identificationModule': {'nctId': 'NCT04468503', 'briefTitle': 'Comparative Effect of Protein Prescription Strategies on Nitrogen Balance and Upshots in Critically Ill Patients', 'organization': {'class': 'OTHER', 'fullName': 'Allama Iqbal Open University Islamabad'}, 'officialTitle': 'Comparative Effect of Protein Prescription Strategies on Nitrogen Balance and Upshots in Critically Ill Patients', 'orgStudyIdInfo': {'id': 'HEC acadmic research'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1 g per kg body weight per day', 'description': 'Protein will be receive by patients that is 1g per kg per day, Patients will be assess and according to patient actual dry weight 1 g per kg of that weight protein will provided, energy will be provided according to ASPEN guideline 2016.\n\nBase line characters(BMI, nitrogen Balance, Protein biomarker, LFTs, RFTs, GCS)', 'interventionNames': ['Other: Two differnt protien prescription (ig per kg per day and 2g per kg /day )will be assigned to each group interventional']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2 g per kg body weight per day', 'description': 'Protein will be receive by patients that is 2g per kg per day, Patients will be assess and according to patient actual dry weight 1 g per kg of that weight protein will provided, energy will be provided according to ASPEN guideline 2016.\n\nBase line characters(BMI, nitrogen Balance, Protein bio marker, LFTs. , RFTs, GCS)', 'interventionNames': ['Other: Two differnt protien prescription (ig per kg per day and 2g per kg /day )will be assigned to each group interventional']}], 'interventions': [{'name': 'Two differnt protien prescription (ig per kg per day and 2g per kg /day )will be assigned to each group interventional', 'type': 'OTHER', 'description': 'In this study intervention will be the dose of protein, one group will be prescribed with the protein dose (1 g/kg/day) and other group will be on prescribed higher dose (2gm/kg/day) of protein according to the ASPEN guideline for critically ill and the energy requirements (other than proteins) will be 25 kcal/kg of adjusted body weight (Picolo et al.,). Each subject in the trail will provide remaining medical nutrition therapy according to the therapeutic guidelines in the field. The medical nutrition management other than protein will be adjust according to need of each patient.', 'armGroupLabels': ['1 g per kg body weight per day', '2 g per kg body weight per day']}]}, 'contactsLocationsModule': {'locations': [{'zip': '46000', 'city': 'Islamabad', 'state': 'Federal', 'country': 'Pakistan', 'facility': 'Allama Iqbal Open University', 'geoPoint': {'lat': 33.72148, 'lon': 73.04329}}], 'overallOfficials': [{'name': 'Dr. Mahpara Safdar, phd', 'role': 'STUDY_CHAIR', 'affiliation': 'Allama Iqbal Open University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'basic detail'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Allama Iqbal Open University Islamabad', 'class': 'OTHER'}, 'collaborators': [{'name': 'Shifa International Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prinicipal Investigator', 'investigatorFullName': 'Zainab Bibi', 'investigatorAffiliation': 'Allama Iqbal Open University Islamabad'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2024-06-27', 'type': 'RELEASE'}, {'date': '2024-10-02', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Zainab Bibi, Prinicipal Investigator, Allama Iqbal Open University Islamabad'}}}}