Ignite Creation Date:
2025-12-25 @ 4:14 AM
Ignite Modification Date:
2025-12-26 @ 3:14 AM
Study NCT ID:
NCT01477320
Status:
COMPLETED
Last Update Posted:
2018-01-16
First Post:
2011-10-04
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Enteral Nutrition as Stress Ulcer Prophylaxis in Critically Ill Patients.
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006471', 'term': 'Gastrointestinal Hemorrhage'}, {'id': 'D004761', 'term': 'Enterocolitis, Pseudomembranous'}], 'ancestors': [{'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D003015', 'term': 'Clostridium Infections'}, {'id': 'D016908', 'term': 'Gram-Positive Bacterial Infections'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D004760', 'term': 'Enterocolitis'}, {'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077402', 'term': 'Pantoprazole'}, {'id': 'D004750', 'term': 'Enteral Nutrition'}], 'ancestors': [{'id': 'D053799', 'term': '2-Pyridinylmethylsulfinylbenzimidazoles'}, {'id': 'D013454', 'term': 'Sulfoxides'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D001562', 'term': 'Benzimidazoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D005248', 'term': 'Feeding Methods'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D018529', 'term': 'Nutritional Support'}, {'id': 'D044623', 'term': 'Nutrition Therapy'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'mohamed.saad@louisville.edu', 'phone': '5028525841', 'title': 'Dr. Mohamed Saad', 'organization': 'University of Louisville'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Pantoprazole 40mg IV Daily and Tube Feed', 'description': 'Pantoprazole 40 mg IV daily and tube feed.: Patients randomized to the control group "active Comparator" will receive tube feed plus an Pantoprazole 40 mg IV daily.', 'otherNumAtRisk': 62, 'otherNumAffected': 0, 'seriousNumAtRisk': 62, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Placebo and Tube Feed.', 'description': 'Placebo and tube feed: Patients randomized to Placebo group "placebo Comparator" will receive tube feed plus an Placebo.', 'otherNumAtRisk': 62, 'otherNumAffected': 0, 'seriousNumAtRisk': 62, 'seriousNumAffected': 1}], 'seriousEvents': [{'term': 'GI bleed', 'stats': [{'groupId': 'EG000', 'numAtRisk': 62, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 62, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Subjects With GI Bleeding', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pantoprazole 40mg IV Daily and Tube Feed', 'description': 'Pantoprazole 40 mg IV daily and tube feed.: Patients randomized to the control group "active Comparator" will receive tube feed plus an Pantoprazole 40 mg IV daily.'}, {'id': 'OG001', 'title': 'Placebo and Tube Feed.', 'description': 'Placebo and tube feed: Patients randomized to Placebo group "placebo Comparator" will receive tube feed plus an Placebo.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Subjects will be followed from date of randomization until discharge from the ICU or cessation of Enteral Nutrition (EN) and successful initiation of oral feeds up to 100 weeks.', 'description': '1. Incidence of overt GI bleeding (as defined by the presence of coffee ground emesis, hematemesis of bright red blood, melena, or hematochezia) seen with Proton Pump Inhibitor (PPI) and EN versus EN alone in critically ill patients.\n2. Incidence of significant GI bleeding, defined by a 3-point decrease in hematocrit within 24 hours accompanied by signs of overt GI bleeding, or by an unexplained 6-point decrease in hematocrit during any 48 hour period.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With ICU-acquired C. Difficile Pseudomembranous Colitis.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pantoprazole 40mg IV Daily and Tube Feed', 'description': 'Pantoprazole 40 mg IV daily and tube feed.: Patients randomized to the control group "active Comparator" will receive tube feed plus an Pantoprazole 40 mg IV daily.'}, {'id': 'OG001', 'title': 'Placebo and Tube Feed.', 'description': 'Placebo and tube feed: Patients randomized to Placebo group "placebo Comparator" will receive tube feed plus an Placebo.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Subjects will be followed until discharge from the ICU or cessation of EN and successful initiation of oral feeds up to 100 weeks.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Pantoprazole 40mg IV Daily and Tube Feed', 'description': 'Pantoprazole 40 mg IV daily and tube feed.: Patients randomized to the control group "active Comparator" will receive tube feed plus an Pantoprazole 40 mg IV daily.'}, {'id': 'FG001', 'title': 'Placebo and Tube Feed.', 'description': 'Placebo and tube feed: Patients randomized to Placebo group "placebo Comparator" will receive tube feed plus an Placebo.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '62'}, {'groupId': 'FG001', 'numSubjects': '62'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '55'}, {'groupId': 'FG001', 'numSubjects': '47'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '15'}]}]}], 'recruitmentDetails': 'Recruitment started in July 2013 in the medical ICU of University of Louisville Hospital. In July 2014, a second recruitment site (medical ICU at Jewish Hospital) was added as a second site for recruitment.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'BG000'}, {'value': '47', 'groupId': 'BG001'}, {'value': '102', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Pantoprazole 40mg IV Daily and Tube Feed', 'description': 'Pantoprazole 40 mg IV daily and tube feed.: Patients randomized to the control group "active Comparator" will receive tube feed plus an Pantoprazole 40 mg IV daily.'}, {'id': 'BG001', 'title': 'Placebo and Tube Feed.', 'description': 'Placebo and tube feed: Patients randomized to Placebo group "placebo Comparator" will receive tube feed plus an Placebo.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '62', 'groupId': 'BG000', 'lowerLimit': '49.5', 'upperLimit': '68'}, {'value': '58', 'groupId': 'BG001', 'lowerLimit': '40.5', 'upperLimit': '66.5'}, {'value': '60', 'groupId': 'BG002', 'lowerLimit': '40.5', 'upperLimit': '68.0'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE', 'populationDescription': 'The patient excluded from analysis were extubated too soon after enrollment before starting tube feed'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '58', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '55', 'groupId': 'BG000'}, {'value': '47', 'groupId': 'BG001'}, {'value': '102', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 124}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-12', 'completionDateStruct': {'date': '2016-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-12-14', 'studyFirstSubmitDate': '2011-10-04', 'resultsFirstSubmitDate': '2017-08-17', 'studyFirstSubmitQcDate': '2011-11-18', 'lastUpdatePostDateStruct': {'date': '2018-01-16', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-12-14', 'studyFirstPostDateStruct': {'date': '2011-11-22', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-01-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Subjects With GI Bleeding', 'timeFrame': 'Subjects will be followed from date of randomization until discharge from the ICU or cessation of Enteral Nutrition (EN) and successful initiation of oral feeds up to 100 weeks.', 'description': '1. Incidence of overt GI bleeding (as defined by the presence of coffee ground emesis, hematemesis of bright red blood, melena, or hematochezia) seen with Proton Pump Inhibitor (PPI) and EN versus EN alone in critically ill patients.\n2. Incidence of significant GI bleeding, defined by a 3-point decrease in hematocrit within 24 hours accompanied by signs of overt GI bleeding, or by an unexplained 6-point decrease in hematocrit during any 48 hour period.'}], 'secondaryOutcomes': [{'measure': 'Number of Subjects With ICU-acquired C. Difficile Pseudomembranous Colitis.', 'timeFrame': 'Subjects will be followed until discharge from the ICU or cessation of EN and successful initiation of oral feeds up to 100 weeks.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Enteral Nutrition', 'Stress Ulcer Prophylaxis', 'Critically Ill Patients', 'Overt and significant GI bleeding', 'Stress gastropathy', 'Clostridium Difficile pseudomembranous colitis', 'Vital AF', 'Small peptide fish oil structured lipids', 'Fructose oligosaccharide'], 'conditions': ['Gastrointestinal Hemorrhage', 'Clostridium Difficile Colitis']}, 'descriptionModule': {'briefSummary': 'study is to determine if proton pump inhibitors plus enteral nutrition is superior to enteral nutrition alone as a stress ulcer prophylaxis strategy in critically ill patients in terms of incidence of overt and significant GI bleeding related to stress gastropathy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18 years or older\n* Admission to the medical ICU at University of Louisville Hospital or Jewish Hospital\n* Expected need for mechanical ventilation \\> 48 hours\n* No contraindication to EN within the first 24 hours after admission to the ICU\n\nExclusion Criteria:\n\n* Evidence of active GI bleeding during current hospitalization prior to study entry\n* Admission to ICU with primary diagnosis of burn injury\n* Closed head injury or increased intracranial pressure\n* Partial or complete gastrectomy\n* Pregnancy or lactation'}, 'identificationModule': {'nctId': 'NCT01477320', 'briefTitle': 'Enteral Nutrition as Stress Ulcer Prophylaxis in Critically Ill Patients.', 'organization': {'class': 'OTHER', 'fullName': 'University of Louisville'}, 'officialTitle': 'Enteral Nutrition as Stress Ulcer Prophylaxis in Critically Ill Patients. Prospective, Double-blind, Randomized, Placebo-controlled Study.', 'orgStudyIdInfo': {'id': '11.0170'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Pantoprazole 40mg IV daily and tube feed', 'interventionNames': ['Drug: Pantoprazole 40 mg IV daily and tube feed.']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo and tube feed.', 'interventionNames': ['Other: Placebo and tube feed']}], 'interventions': [{'name': 'Pantoprazole 40 mg IV daily and tube feed.', 'type': 'DRUG', 'otherNames': ['Tube feed formula:(Vital AF "Advanced Formula" 1.2 Cal(TM),Abbott,Columbus,OH)'], 'description': 'Patients randomized to the control group "active Comparator" will receive tube feed plus an Pantoprazole 40 mg IV daily.', 'armGroupLabels': ['Pantoprazole 40mg IV daily and tube feed']}, {'name': 'Placebo and tube feed', 'type': 'OTHER', 'otherNames': ['Tube feed formula:(Vital AF "Advanced Formula" 1.2 Cal(TM),Abbott,Columbus,OH)'], 'description': 'Patients randomized to Placebo group "placebo Comparator" will receive tube feed plus an Placebo.', 'armGroupLabels': ['Placebo and tube feed.']}]}, 'contactsLocationsModule': {'locations': [{'zip': '40202', 'city': 'Louisville', 'state': 'Kentucky', 'country': 'United States', 'facility': 'University of Louisville hospital', 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}], 'overallOfficials': [{'name': 'Mohamed Saad, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Louisville'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mohamed Saad', 'class': 'OTHER'}, 'collaborators': [{'name': 'Abbott Nutrition', 'class': 'INDUSTRY'}, {'name': 'University of Louisville', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Primary Investigator', 'investigatorFullName': 'Mohamed Saad', 'investigatorAffiliation': 'University of Louisville'}}}}