Ignite Creation Date:
2025-12-26 @ 11:10 AM
Ignite Modification Date:
2026-03-07 @ 8:57 AM
Study NCT ID:
NCT00590928
Status:
COMPLETED
Last Update Posted:
2008-01-11
First Post:
2007-12-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Gastric pH in Critically Ill Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D064098', 'term': 'Esomeprazole'}, {'id': 'D011899', 'term': 'Ranitidine'}], 'ancestors': [{'id': 'D009853', 'term': 'Omeprazole'}, {'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': 'D005663', 'term': 'Furans'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 75}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-12', 'completionDateStruct': {'date': '2006-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2007-12-26', 'studyFirstSubmitDate': '2007-12-26', 'studyFirstSubmitQcDate': '2007-12-26', 'lastUpdatePostDateStruct': {'date': '2008-01-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-01-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the percentage of time with gastric pH > 4', 'timeFrame': '72 hours'}], 'secondaryOutcomes': [{'measure': 'median gastric pH', 'timeFrame': '72 hours'}, {'measure': 'incidence of gastrointestinal bleeding', 'timeFrame': '72 hours'}, {'measure': 'incidence of ventilator associated pneumonia', 'timeFrame': 'ICU stay'}, {'measure': 'the percentage of time with an gastric pH > 5', 'timeFrame': '72 hours'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Critically Ill Patients', 'Indication for Stress Ulcer Prophylaxis']}, 'descriptionModule': {'briefSummary': 'H2-receptor antagonists are the gold standard for stress ulcer prophylaxis in critically ill patients. Various studies demonstrated superiority of proton pump inhibitors over H2-receptor antagonists in increasing gastric pH and in healing gastric acid-dependent diseases. It is unknown, whether proton pump inhibitors are more effective in increasing gastric pH than H2-receptor antagonists in critically ill patients requiring stress ulcer prophylaxis.', 'detailedDescription': 'Gastric pH is measured continuously for 72 hours with a pipolar microelectrode placed between 7 and 15cm below the lower esophageal sphincter.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* critically ill patients\n* indication for stress ulcer prophylaxis\n* gastric pH \\< 4\n\nExclusion Criteria:\n\n* gastrointestinal bleeding\n* gastric pH \\> 4'}, 'identificationModule': {'nctId': 'NCT00590928', 'briefTitle': 'Gastric pH in Critically Ill Patients', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of Vienna'}, 'officialTitle': 'Effect of Intravenous Esomeprazole Versus Ranitidine on Gastric pH in Critically Ill Patients - a Prospective, Randomized, Double-Blind Study.', 'orgStudyIdInfo': {'id': '13H1-CM1'}, 'secondaryIdInfos': [{'id': 'ESORAN trail'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1', 'description': 'patients with indication for stress ulcer prophylaxis and gastric pH \\< 4', 'interventionNames': ['Drug: esomeprazole']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'patients with indication for stress ulcer prophylaxis and gastric pH \\< 4', 'interventionNames': ['Drug: ranitidine']}], 'interventions': [{'name': 'esomeprazole', 'type': 'DRUG', 'description': '40mg once daily', 'armGroupLabels': ['1']}, {'name': 'ranitidine', 'type': 'DRUG', 'description': '50mg every h hours', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1090', 'city': 'Vienna', 'country': 'Austria', 'facility': 'Medical University of Vienna, Department of Medicine III, ICU', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}], 'overallOfficials': [{'name': 'Christian Madl, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medical University of Vienna'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of Vienna', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Christian Madl, MD', 'oldOrganization': 'Medical University of Vienna'}}}}