Ignite Creation Date:
2025-12-25 @ 2:42 AM
Ignite Modification Date:
2026-02-03 @ 11:51 AM
Study NCT ID:
NCT06586333
Status:
COMPLETED
Last Update Posted:
2024-09-19
First Post:
2024-09-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Optimizing Stress Ulcer Prophylaxis Practices and Reducing Associated Costs in Intensive Care Units: a Nonrandomized Controlled Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004381', 'term': 'Duodenal Ulcer'}], 'ancestors': [{'id': 'D010437', 'term': 'Peptic Ulcer'}, {'id': 'D004378', 'term': 'Duodenal Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D013272', 'term': 'Stomach Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D010595', 'term': 'Pharmacists'}], 'ancestors': [{'id': 'D006282', 'term': 'Health Personnel'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Study Design and Participants The study is a prospectively designed, nonrandomized controlled study. It was conducted for six months at the EICU and GICU of a training and research hospital between 1 Jun 2023 and 1 December 2023.\n\nThe study involved GICU patients as the standard care services observation group (OG). The use of SUP in the GICU was only monitored and noted. In the EICU, patients were identified as part of the recruiting guideline group (GG), and in addition to receiving usual care, they were managed for SUP according to the ASHP SUP guidelines \\[1\\]. The study duration was six months concurrently in the EICU and the GICU. Before inclusion, written informed consent was obtained from each patient or their parent(s)/legal guardian(s). Subjects with incomplete data were excluded. The inclusion criteria were patients aged ≥18 years and hospitalized for ≥24 hours in the EICU/GICU. Patients with a history of stomach cancer, admission to the ICU because of GI bleeding, subtotal/tot'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 196}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2023-12-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-09-04', 'studyFirstSubmitDate': '2024-09-04', 'studyFirstSubmitQcDate': '2024-09-04', 'lastUpdatePostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adherence rates to ASHP guidelines', 'timeFrame': '6 months', 'description': '% of physician who adhere to ASHP guidelines'}], 'secondaryOutcomes': [{'measure': 'Cost saving', 'timeFrame': '6 months', 'description': 'The cost saving by adhere to ASHP guidelines'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['guidelines', 'adherence', 'stress ulcer', 'intensive care'], 'conditions': ['Stress Ulcer']}, 'descriptionModule': {'briefSummary': 'The study is a prospectively designed, nonrandomized controlled study. It was conducted for six months at the EICU and GICU of a training and research hospital between 1 Jun 2023 and 1 December 2023.', 'detailedDescription': 'The study involved GICU patients as the standard care services observation group (OG). The use of SUP in the GICU was only monitored and noted. In the EICU, patients were identified as part of the recruiting guideline group (GG), and in addition to receiving usual care, they were managed for SUP according to the ASHP SUP guidelines \\[1\\]. The study duration was six months concurrently in the EICU and the GICU. Before inclusion, written informed consent was obtained from each patient or their parent(s)/legal guardian(s). Subjects with incomplete data were excluded. The inclusion criteria were patients aged ≥18 years and hospitalized for ≥24 hours in the EICU/GICU. Patients with a history of stomach cancer, admission to the ICU because of GI bleeding, subtotal/total gastrectomy, or receiving a proton pump inhibitor for therapeutic purposes were excluded from the study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The inclusion criteria were patients aged ≥18 years and hospitalized for ≥24 hours in the EICU/GICU.\n\nExclusion Criteria:\n\n* Patients with a history of stomach cancer, admission to the ICU because of GI bleeding, subtotal/total gastrectomy, or receiving a proton pump inhibitor for therapeutic purposes were excluded from the study.'}, 'identificationModule': {'nctId': 'NCT06586333', 'briefTitle': 'Optimizing Stress Ulcer Prophylaxis Practices and Reducing Associated Costs in Intensive Care Units: a Nonrandomized Controlled Study', 'organization': {'class': 'OTHER', 'fullName': 'Altinbas University'}, 'officialTitle': 'Evaluation of the Effect of an Education Program on Reducing the Efficacy and Costs of Inappropriate Stress Ulcer Prophylaxis in Intensive Care Units', 'orgStudyIdInfo': {'id': '2023/181'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control Group', 'description': 'Involved GICU patients as the standard care services observation group (OG). Stress ulcer prophylaxis were only observed and no intervention done'}, {'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': 'In the EICU, patients were identified as part of the recruiting guideline group (GG), and in addition to receiving usual care, they were managed for SUP according to the ASHP stress ulcer prophylaxis guidelines', 'interventionNames': ['Drug: stress ulcer prophylaxis']}], 'interventions': [{'name': 'stress ulcer prophylaxis', 'type': 'DRUG', 'otherNames': ['clinical pharmacist'], 'description': 'In the EICU, patients were identified as part of the recruiting guideline group (GG), and in addition to receiving usual care, they were managed for SUP according to the ASHP SUP guidelines', 'armGroupLabels': ['Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34147', 'city': 'Istanbul', 'state': 'Turkey', 'country': 'Turkey (Türkiye)', 'facility': 'Prof. Dr. Cemil Taşcıoğlu City Hospital, Clinical Pharmacy, İstanbul, Türkiye,', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'overallOfficials': [{'name': 'yunus emre Ayhan, Specialist clinical pharmacy', 'role': 'STUDY_CHAIR', 'affiliation': 'Prof. Dr. Cemil Taşcıoğlu City Hospital, Clinical Pharmacy, İstanbul, Türkiye,'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Altinbas University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assoc.Professor', 'investigatorFullName': 'Nilay Aksoy', 'investigatorAffiliation': 'Altinbas University'}}}}