Ignite Creation Date:
2025-12-24 @ 1:59 PM
Ignite Modification Date:
2025-12-27 @ 10:32 PM
Study NCT ID:
NCT01934595
Status:
WITHDRAWN
Last Update Posted:
2017-06-07
First Post:
2013-08-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Optimal Protein Supplementation for 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': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2013-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-06', 'completionDateStruct': {'date': '2017-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-06-06', 'studyFirstSubmitDate': '2013-08-29', 'studyFirstSubmitQcDate': '2013-08-29', 'lastUpdatePostDateStruct': {'date': '2017-06-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-09-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Number of days in ICU', 'timeFrame': '28 days'}, {'measure': 'Infection Rate', 'timeFrame': '28 days'}, {'measure': 'Discharge location', 'timeFrame': '28 days'}, {'measure': 'New or Significantly worsening skin breakdown', 'timeFrame': '28 days'}, {'measure': 'Mechanical Vent free days', 'timeFrame': '28 days'}], 'primaryOutcomes': [{'measure': 'Cumulative Organ failure free days', 'timeFrame': '28 days', 'description': "The primary outcome will be cumulative organ failure free days (defined as no aggressive medical support for the patient's vital organ systems; including cardiovascular, respiratory, renal, bone marrow, and liver."}], 'secondaryOutcomes': [{'measure': 'Mortality', 'timeFrame': '28 days'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Critically ill', 'Protein', 'Supplement', 'ICU', 'Protein synthesis'], 'conditions': ['Critical Illness']}, 'descriptionModule': {'briefSummary': 'It is well accepted that during critical illness there is an increase in protein breakdown and loss of lean body mass. Previous studies have shown that during critical illness muscle breakdown increases dramatically. The aim of our study is to test the hypothesis that critically ill patients have improved outcomes with higher protein supplementation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* • Medical or surgical patients who are admitted or transferred to the ICU with an APACHE II score greater than or equal to 18 and who are candidates for enteral nutrition within 48 hours of admission.\n\nExclusion Criteria:\n\n* • Patients who cannot tolerate enteral nutrition\n\n * Patients who have a contraindication for enteral nutrition per American Society of Enteral and Parenteral Nutrition guidelines (GI obstruction, intractable nausea and/or vomiting, short bowel syndrome, distal GI fistula, GI bleeding that will require endoscopy, malabsorption that requires TPN, inability to access the GI tract\n * Patients with chronic stage III or IV kidney disease and/or patients receiving dialysis within six months of this hospital admission as these patients are known to require specific protein diets as an outpatient. Patients with acute kidney injury will not be excluded as there is no evidence to suggest these patients require a specific protein diet secondary to their acute kidney injury.\n * Patients with refractory hypotension unresponsive to vasoactive medications\n * Patients who are unlikely to survive the next 48 hours at the time of enrollment (this will be judged by the treating physician)\n * Patients who are unable to give consent and do not have a family member able to give consent on his/her behalf.\n * Patients with end stage liver disease or undergoing liver transplant or liver resection surgery\n * Patients whose physician thinks he/she should not participate\n * Prisoners\n * Pregnant women (all female of childbearing age will have a urine pregnancy test prior to randomization)'}, 'identificationModule': {'nctId': 'NCT01934595', 'briefTitle': 'Optimal Protein Supplementation for Critically Ill Patients', 'organization': {'class': 'OTHER', 'fullName': 'University of Oklahoma'}, 'officialTitle': 'Optimal Protein Supplementation for Critically Ill Patients', 'orgStudyIdInfo': {'id': '3440'}, 'secondaryIdInfos': [{'id': 'SCCM Vision', 'type': 'OTHER_GRANT', 'domain': 'SCCM Vision Grant'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Varying amounts of Beneprotein', 'description': '1.5grams/kg/day, 2.0 grams/kg/day, and 2.5 grams/kg, day', 'interventionNames': ['Dietary Supplement: Beneprotein']}, {'type': 'ACTIVE_COMPARATOR', 'label': '1 Gram - Standard Therapy given in ICU', 'description': '1 gram/kg/day of protein', 'interventionNames': ['Dietary Supplement: Beneprotein']}], 'interventions': [{'name': 'Beneprotein', 'type': 'DIETARY_SUPPLEMENT', 'description': 'The study will compare different protein supplementation amounts to determine if increased protein supplementation in critically ill patients improves outcomes.', 'armGroupLabels': ['1 Gram - Standard Therapy given in ICU', 'Varying amounts of Beneprotein']}]}, 'contactsLocationsModule': {'locations': [{'zip': '73104', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'OUHSC', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}], 'overallOfficials': [{'name': 'Karen S Allen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'OUHSC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Oklahoma', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}