Ignite Creation Date:
2025-12-24 @ 4:15 PM
Ignite Modification Date:
2025-12-27 @ 9:40 AM
Study NCT ID:
NCT04961866
Status:
COMPLETED
Last Update Posted:
2021-08-10
First Post:
2021-06-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Parenteral Protein Concentrations in Critically Ill Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D010288', 'term': 'Parenteral Nutrition'}], 'ancestors': [{'id': 'D005248', 'term': 'Feeding Methods'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D018529', 'term': 'Nutritional Support'}, {'id': 'D044623', 'term': 'Nutrition Therapy'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'completionDateStruct': {'date': '2021-03-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-08-03', 'studyFirstSubmitDate': '2021-06-28', 'studyFirstSubmitQcDate': '2021-07-04', 'lastUpdatePostDateStruct': {'date': '2021-08-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-07-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-03-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'hand grip strength', 'timeFrame': '10 days', 'description': 'hand grip strength using dynamometer'}], 'secondaryOutcomes': [{'measure': 'ultrasound guided muscle thickness', 'timeFrame': '10 days', 'description': 'us guided biceps and forearm muscle thickness'}, {'measure': 'nitrogen balances', 'timeFrame': '10 days', 'description': 'Measurements'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['protein', 'parenteral', 'critical ill patient', 'ICU'], 'conditions': ['Hand Muscle Strain']}, 'descriptionModule': {'briefSummary': 'Sixty patients who need Parenteral nutrition for more than 48h will be assigned into two groups .Group A (n=30) patient will receive 1g/kg/day protein and group B n=30) patient will receive 2g /kg/day. In both groups caloric requirement will be fixed at 25- 30 kcal /kg/d.', 'detailedDescription': "In this study after obtaining approval from our hospital ethics committee, a written informed consent will be obtained from patient's next of kin.\n\nSixty patients who need PN for more than 48h will be assigned into two groups .Group A (n=30) patient will receive 1g/kg/day protein and group B n=30) patient will receive 2g /kg/day. In both groups caloric requirement will be fixed at 25- 30 kcal /kg/d.\n\nInclusion criteria:\n\nAge: from 18 to 60 years Sex : male or female Predicted to be in icu ≥ 48 hs Predicted to have PN for\\> 48 hs.\n\nExclusion criteria:\n\nPregnant female Hepatic patients Renal patients Age \\<18 years\n\nTechnique of the study :\n\n60 abdominal surgery/trauma ICU patients who have a contraindication or intolerance to enteral nutrition(EN),will be fed parenterally within 24-48 h from admission and divided according to the protein delivery into two groups.\n\nGroup A , those patients will receive parenteral proteins in a dose of 1 g/kg/day.\n\nGroup B, those patients will receive parenteral proteins in a dose of 2g/kg /day The nutrition will be delivered through a central line and using separate bottles technique ,because of the lack of a compounding unit and commercial bags in our hospital, After exclusion of the protein calories (will be given as 10%aa )the rest of energy requirement will be divided between carbohydrates (glucose25%)and lipids(SMOF20%) in a ratio of 60:40 Serum electrolytes, blood glucose, lipid profile and serum creatinine will be monitored and corrected regularly in every patient\n\nThe two groups will be compared as regarding the following :\n\nhand grip strength Time of staying on Icu Time of staying in hospital Ultrasound biceps muscle thickness Nitrogen balances"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age: from 18 to 70 years Sex : male or female Predicted to be in icu ≥ 48 hs Predicted to have PN for\\> 48 hs.\n\nExclusion Criteria:\n\n\\- Hepatic patients Renal patients Age \\<18 years'}, 'identificationModule': {'nctId': 'NCT04961866', 'briefTitle': 'Effects of Parenteral Protein Concentrations in Critically Ill Patients', 'organization': {'class': 'OTHER', 'fullName': 'Minia University'}, 'officialTitle': 'Effects of Parenteral Protein Concentrations in Critically Ill Patients in Icu (Comparative Study)', 'orgStudyIdInfo': {'id': '308:10/2019'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group A', 'description': 'patients received 1 g/ kg of protein', 'interventionNames': ['Dietary Supplement: parenteral protein 1 g/kg']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group B', 'description': 'patients received 2 g/ kg of protein', 'interventionNames': ['Dietary Supplement: Parenteral nutrition 2 g/kg']}], 'interventions': [{'name': 'parenteral protein 1 g/kg', 'type': 'DIETARY_SUPPLEMENT', 'description': 'patients received 1 g/ kg of protein', 'armGroupLabels': ['Group A']}, {'name': 'Parenteral nutrition 2 g/kg', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Patients received 2 g/ kg of protein', 'armGroupLabels': ['Group B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '61111', 'city': 'Minya', 'country': 'Egypt', 'facility': 'Karim Naser Hasan', 'geoPoint': {'lat': 28.09193, 'lon': 30.75813}}], 'overallOfficials': [{'name': 'Ibrahim A. Youssif, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Minia University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Minia University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'assisstant lecturer', 'investigatorFullName': 'Karim Naser Hasan', 'investigatorAffiliation': 'Minia University'}}}}