Ignite Creation Date:
2025-12-24 @ 4:40 PM
Ignite Modification Date:
2025-12-25 @ 2:29 PM
Study NCT ID:
NCT00179166
Status:
TERMINATED
Last Update Posted:
2010-09-27
First Post:
2005-09-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Assessment of Metabolic Response in Critically Ill Patients With Acute Renal Failure
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D058186', 'term': 'Acute Kidney Injury'}], 'ancestors': [{'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 3}}, 'statusModule': {'whyStopped': 'lack of enrollment', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2004-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-09', 'completionDateStruct': {'date': '2005-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-09-23', 'studyFirstSubmitDate': '2005-09-13', 'studyFirstSubmitQcDate': '2005-09-13', 'lastUpdatePostDateStruct': {'date': '2010-09-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2005-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'whole-body net protein balance', 'timeFrame': '10 hours'}], 'secondaryOutcomes': [{'measure': 'Net skeletal muscle protein balance', 'timeFrame': '10 hours'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Acute Renal Failure']}, 'descriptionModule': {'briefSummary': 'We hypothesize that a nutritional supplementation with higher than standard protein content (2.0 gm/Kg/day vs 1.4 gm/Kg/day) will result in improved whole-body net protein balance when administered to critically ill patients with acute renal failure (ARF).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults ≥ 18 years of age admitted to the intensive care unit\n* New onset acute renal failure (ARF) or ARF superimposed on chronic kidney disease\n* ARF will be defined by a sustained (over 24 hours) increase in serum creatinine \\> 0.5 mg/dl from baseline\n* Patients will be recruited for the study within 3-5 days following establishment of ARF\n\nExclusion Criteria:\n\n* Institutionalized patient\n* Previous kidney transplant\n* Pregnancy\n* Unable to obtain consent from subject or legally recognized representative\n* ARF from urinary tract obstruction or a volume responsive pre-renal state.\n* Liver Failure\n* Recent cerebrovascular accident (CVA)\n* Coagulopathy defined as: Platelets \\< 50, PT \\> 20, INR \\> 2.0 if the patient requires the placement of an arterial or venous catheter; if the patient does not require the placement of an arterial or venous catheter for the study, coagulopathy will not be a basis for exclusion.\n* Life expectancy \\< 48 hours'}, 'identificationModule': {'nctId': 'NCT00179166', 'briefTitle': 'Assessment of Metabolic Response in Critically Ill Patients With Acute Renal Failure', 'organization': {'class': 'OTHER', 'fullName': 'Vanderbilt University'}, 'officialTitle': 'Assessment of Metabolic Response in Critically Ill Patients With Acute Renal Failure', 'orgStudyIdInfo': {'id': '30941'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1', 'description': 'supplement contains protein content of 1.4 g/kg/day', 'interventionNames': ['Drug: TPN nutritional supplement']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'supplement contains protein content of 2.0 g/kg/day', 'interventionNames': ['Drug: TPN nutritional supplement']}], 'interventions': [{'name': 'TPN nutritional supplement', 'type': 'DRUG', 'description': 'intravenous administration of nutritional supplement for 4 hours at a dosage of 30 kcal/kg/day, in the form of lipids, carbohydrates and protein; the non-protein calories are comprised of lipids (30%) and carbohydrates (70%)', 'armGroupLabels': ['1', '2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '37232', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Vanderbilt University', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}], 'overallOfficials': [{'name': 'Alp Ikizler, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Vanderbilt University Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vanderbilt University', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Alp Ikizler, MD', 'oldOrganization': 'Vanderbilt University Medical Center'}}}}