Ignite Creation Date:
2025-12-25 @ 1:28 AM
Ignite Modification Date:
2025-12-27 @ 10:48 PM
Study NCT ID:
NCT04078594
Status:
COMPLETED
Last Update Posted:
2023-03-14
First Post:
2019-01-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Electronic Early Notification of Sepsis in Hospitalized Ward Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018805', 'term': 'Sepsis'}], 'ancestors': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D018746', 'term': 'Systemic Inflammatory Response Syndrome'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'The electronic alert will be masked on the control wards.'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Stepped-wedge Cluster Randomized Controlled Trial'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 65250}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'completionDateStruct': {'date': '2022-11-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-03-12', 'studyFirstSubmitDate': '2019-01-17', 'studyFirstSubmitQcDate': '2019-09-01', 'lastUpdatePostDateStruct': {'date': '2023-03-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-09-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-08-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'All-cause hospital mortality by day 90', 'timeFrame': '90 Day', 'description': 'Percentage of all-cause hospital mortality'}], 'secondaryOutcomes': [{'measure': 'Hospital length of stay', 'timeFrame': '90 Day', 'description': 'Censored at 90 days'}, {'measure': 'Transfer to ICU', 'timeFrame': '90 Day', 'description': 'ICU admission within 90 days'}, {'measure': 'ICU-free days', 'timeFrame': '90 Day', 'description': 'In the first 90 days'}, {'measure': 'Critical care response team activation', 'timeFrame': '90 Day', 'description': 'Critical care response team activation within 90 days'}, {'measure': 'Cardiac arrest', 'timeFrame': '90 Day', 'description': 'Cardiac arrest within 90 days'}, {'measure': 'The need for mechanical ventilation, vasopressor therapy, and incident renal replacement therapy', 'timeFrame': '90 Day', 'description': 'Within 90 days'}, {'measure': 'Antibiotic-free days', 'timeFrame': '90 Day', 'description': 'Antibiotic-free days within 90 days'}, {'measure': 'The acquisition of MDROs', 'timeFrame': '90 Day', 'description': 'The percentage of patients with MDROs within 90 days'}, {'measure': 'Clostridium difficile infection', 'timeFrame': '90 Day', 'description': 'The percentage of patients with clostridium difficile infection within 90 days'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['sepsis', 'ward patients', 'Screening', 'qSOFA'], 'conditions': ['Sepsis']}, 'referencesModule': {'references': [{'pmid': '39658862', 'type': 'DERIVED', 'citation': 'Arabi YM, Alsaawi A, Alzahrani M, Al Khathaami AM, AlHazme RH, Al Mutrafy A, Al Qarni A, Vishwakarma RK, Al Anazi R, Al Qasim E, Abdukahil SA, Al-Rabeah FK, Al Ghamdi H, Alatassi A, Al-Dorzi HM, Al-Hameed F, Babakr R, Alghamdi AA, Bin Salih S, Alharbi A, AlKatheri ME, Mustafa H, Al-Qahtani S, Al Qahtani S, Alselaim N, Tashkandi N, Alyami AH, Alyousef Z, AlDibasi O, Al-Qahtani AH, Aldawood A, Caswell A, Al Ayadhi N, Al Rehaili H, Al Arfaj A, Al Mubarak H, Alwasaidi T, Zahrani S, Alalawi Y, Alhadab A, Nasser T, Omer T, Al Johani SM, Alajlan A, Sadat M, Alzunitan M, Al Mohrij S; SCREEN Trial Group and the Saudi Critical Care Trials Group. Electronic Sepsis Screening Among Patients Admitted to Hospital Wards: A Stepped-Wedge Cluster Randomized Trial. JAMA. 2025 Mar 4;333(9):763-773. doi: 10.1001/jama.2024.25982.'}, {'pmid': '34809672', 'type': 'DERIVED', 'citation': 'Arabi YM, Vishwakarma RK, Al-Dorzi HM, Al Qasim E, Abdukahil SA, Al-Rabeah FK, Al Ghamdi H, Al Ghamdi E; SCREEN Trial Group. Statistical analysis plan for the Steppedwedge Cluster Randomized trial of Electronic Early Notification of sepsis in hospitalized ward patients (SCREEN). Trials. 2021 Nov 22;22(1):828. doi: 10.1186/s13063-021-05788-3.'}, {'pmid': '34635151', 'type': 'DERIVED', 'citation': 'Arabi YM, Alsaawi A, Al Zahrani M, Al Khathaami AM, AlHazme RH, Al Mutrafy A, Al Qarni A, Al Shouabi A, Al Qasim E, Abdukahil SA, Al-Rabeah FK, Al Ghamdi H, Al Ghamdi E, Alansari M, Abuelgasim KA, Alatassi A, Alchin J, Al-Dorzi HM, Ghamdi AA, Al-Hameed F, Alharbi A, Hussein M, Jastaniah W, AlKatheri ME, AlMarhabi H, Mustafa HT, Jones J, Al-Qahtani S, Qahtani S, Qureshi AS, Salih SB, Alselaim N, Tashkandi N, Vishwakarma RK, AlWafi E, Alyami AH, Alyousef Z; SCREEN Trial Group. Electronic early notification of sepsis in hospitalized ward patients: a study protocol for a stepped-wedge cluster randomized controlled trial. Trials. 2021 Oct 11;22(1):695. doi: 10.1186/s13063-021-05562-5.'}]}, 'descriptionModule': {'briefSummary': 'Screening for sepsis has been recommended by the Surviving Sepsis Campaign Clinical Practice Guidelines to facilitate early identification and early management of sepsis. However, the optimal tool remains unknown.The objective of this trial is to examine the effect of an electronic sepsis alert tool on reducing hospital mortailty in patients admitted to medical-surgical-oncology wards.', 'detailedDescription': 'The study aims to examine the effect of screening for sepsis using an electronic sepsis alert versus no alert in hospitalized patients admitted to wards using an active sepsis alert system compared with wards with no active (masked) sepsis alert system on hospital mortality by day 90.\n\nThe wards will be randomized in a stepped-wedge cluster fashion.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '14 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Ward level inclusion and exclusion criteria\n\nInclusion Criteria:\n\n1\\. Inpatient wards, defined as wards used to manage inpatients, in the five Ministry of National Guard Health Affairs (MNGHA) hospitals, Kingdom of Saudi Arabia\n\nExclusion Criteria:\n\n1. Cardiology, transplant, pediatric, obstetric wards\n2. Intensive Care Units and Emergency Department\n3. Operating rooms\n4. Outpatients\n5. Day care wards, endoscopy, outpatient procedure areas, hemodialysis units.\n\nPatient level inclusion and exclusion criteria\n\nInclusion Criteria:\n\n1. Aged 14 years or older\n2. Checked in as inpatient status to one of the study ward\n\nExclusion Criteria:\n\n1\\. No commitment for full life support on the time of arrival to the study ward'}, 'identificationModule': {'nctId': 'NCT04078594', 'acronym': 'SCREEN', 'briefTitle': 'Electronic Early Notification of Sepsis in Hospitalized Ward Patients', 'organization': {'class': 'OTHER', 'fullName': 'King Abdullah International Medical Research Center'}, 'officialTitle': 'Stepped-wedge Cluster Randomized Controlled Trial of Electronic Early Notification of Sepsis in Hospitalized Ward Patients (SCREEN)', 'orgStudyIdInfo': {'id': 'RC18/112'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental wards', 'description': 'Active sepsis e-alert', 'interventionNames': ['Other: sepsis e-alert']}, {'type': 'NO_INTERVENTION', 'label': 'Contol wards', 'description': 'Masked sepsis e-alert.\n\nThe wards will have masked sepsis e-alert.'}], 'interventions': [{'name': 'sepsis e-alert', 'type': 'OTHER', 'description': 'At 2-each month interval, the e-alert will be activated in five new randomly selected wards, until all wards eventually will have active alert', 'armGroupLabels': ['Experimental wards']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11426', 'city': 'Riyadh', 'country': 'Saudi Arabia', 'facility': 'Intensive Care Department, King Abdulaziz Medical City, National Guard Health Affairs', 'geoPoint': {'lat': 24.68773, 'lon': 46.72185}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'King Abdullah International Medical Research Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'King Abdulaziz Medical City, Jeddah', 'class': 'UNKNOWN'}, {'name': 'Prince Mohammed Bin Abdul Aziz Hospital - AlMadinah', 'class': 'UNKNOWN'}, {'name': 'King Abdulaziz Hospital, Al Ahsa', 'class': 'UNKNOWN'}, {'name': 'Imam Abdulrahman Al Faisal Hospital - Dammam', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chairman intensive care unit', 'investigatorFullName': 'Dr Yaseen Arabi', 'investigatorAffiliation': 'King Abdullah International Medical Research Center'}}}}