Ignite Creation Date:
2025-12-24 @ 10:35 PM
Ignite Modification Date:
2025-12-31 @ 1:25 PM
Study NCT ID:
NCT01448135
Status:
COMPLETED
Last Update Posted:
2015-06-23
First Post:
2011-10-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Tolerance and Efficacy of a Predigested, High Protein, High Omega 3 Fat Enteral Feeding Formula Versus a Standard Formula In Multiple Intensive Care Unit Settings
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': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-01', 'completionDateStruct': {'date': '2014-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-06-22', 'studyFirstSubmitDate': '2011-10-03', 'studyFirstSubmitQcDate': '2011-10-05', 'lastUpdatePostDateStruct': {'date': '2015-06-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-10-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Improved tolerance to enteral (tube) feeding', 'timeFrame': 'Baseline and 21 Days', 'description': 'Measure incidence of diarrhea, nausea, vomiting, increased gastric residual, etc.'}], 'secondaryOutcomes': [{'measure': 'Improved delivery of prescribed calories', 'timeFrame': 'Baseline and 21 Days', 'description': 'Measurement of volume of feeding product actually delivered to patient is part of the daily flow-sheet data.'}, {'measure': 'Decreased incidence of complications', 'timeFrame': 'Baseline and 21 Days', 'description': 'Measure incidence of diarrhea, nausea, vomiting, increased gastric residual, etc.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Critical Illness', 'Enteral Feeding']}, 'referencesModule': {'references': [{'pmid': '27161892', 'type': 'DERIVED', 'citation': 'Seres DS, Ippolito PR. Pilot study evaluating the efficacy, tolerance and safety of a peptide-based enteral formula versus a high protein enteral formula in multiple ICU settings (medical, surgical, cardiothoracic). Clin Nutr. 2017 Jun;36(3):706-709. doi: 10.1016/j.clnu.2016.04.016. Epub 2016 Apr 26.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this pilot study is to assess the efficacy, safety and tolerance profile of the enteral feeding product VITAL AF (a semi-elemental, high protein, and high omega-3 fish oil) when compared to Osmolite 1.2, a standard feeding product in critically ill and/or post surgical patients in the intensive care unit (ICU). If enough patients are recruited, inferences about impact on outcomes may also be drawn.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Subject requires enteral tube feeding as sole source of nourishment\n* Subject, or subject's legally acceptable representative (LAR), has provided voluntarily and informed consent form, as deemed appropriate and approved by the Columbia University Medical Center Institutional Review Board\n* Subject is ≥ 18 years of age\n* Subject is male or non-pregnant female at least six weeks postpartum and non-lactating females of childbearing potential will be required to confirm non-pregnancy status with a pregnancy test at screening\n* Subject has an initial APACHE II score less than or equal to 24\n\nExclusion Criteria:\n\n* Subject requires parenteral nutrition\n* Subject is acutely impacted or constipated\n* Subject has intestinal obstruction\n* Subject is too hemodynamically unstable for enteral feeding\n* Subject has an allergy or intolerance to any ingredient in the study product by documentation or verbal report by subject or subject's LAR\n* Subject is participating in a non-Abbott approved concomitant trial\n* Subject has gastrointestinal disease, including acute pancreatitis, active gastrointestinal bleeding, acute inflammatory bowel disease, or has undergone intestinal surgery within the past month"}, 'identificationModule': {'nctId': 'NCT01448135', 'briefTitle': 'Tolerance and Efficacy of a Predigested, High Protein, High Omega 3 Fat Enteral Feeding Formula Versus a Standard Formula In Multiple Intensive Care Unit Settings', 'organization': {'class': 'OTHER', 'fullName': 'Columbia University'}, 'officialTitle': 'Pilot Study Evaluating the Efficacy, Tolerance and Safety of VITAL AF (Semi Elemental, High Protein, High Omega 3 Fat Enteral Formula) Versus Osmolite 1.2 (High Protein Enteral Formula) in Multiple ICU Settings (Medical, Surgical, Cardiothoracic)', 'orgStudyIdInfo': {'id': 'AAAI1205'}, 'secondaryIdInfos': [{'id': 'ANUS1015', 'type': 'OTHER_GRANT', 'domain': 'ABBOTT Nutrition'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Vital AF', 'interventionNames': ['Other: VITAL AF']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Osmolite 1.2', 'interventionNames': ['Other: Osmolite 1.2']}], 'interventions': [{'name': 'VITAL AF', 'type': 'OTHER', 'description': 'Semi-elemental, high protein, and high omega-3 fish oil enteral formula', 'armGroupLabels': ['Vital AF']}, {'name': 'Osmolite 1.2', 'type': 'OTHER', 'description': 'High protein enteral formula', 'armGroupLabels': ['Osmolite 1.2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10032', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'NewYork-Presbyterian Hospital at Columbia University Medical Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Ira J Goldberg, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Columbia University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Columbia University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Abbott Nutrition', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dickinson W. Richards, Jr. Professor of Medicine', 'investigatorFullName': 'Ira Jay Goldberg', 'investigatorAffiliation': 'Columbia University'}}}}