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| Name | Class |
|---|---|
| King Abdulaziz Medical City, Jeddah | UNKNOWN |
| Prince Mohammed Bin Abdul Aziz Hospital - AlMadinah | UNKNOWN |
| King Abdulaziz Hospital, Al Ahsa | UNKNOWN |
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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.
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.
The wards will be randomized in a stepped-wedge cluster fashion.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental wards | Experimental | Active sepsis e-alert |
|
| Contol wards | No Intervention | Masked sepsis e-alert. The wards will have masked sepsis e-alert. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| sepsis e-alert | Other | 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 |
|
| Measure | Description | Time Frame |
|---|---|---|
| All-cause hospital mortality by day 90 | Percentage of all-cause hospital mortality | 90 Day |
| Measure | Description | Time Frame |
|---|---|---|
| Hospital length of stay | Censored at 90 days | 90 Day |
| Transfer to ICU | ICU admission within 90 days | 90 Day |
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Ward level inclusion and exclusion criteria
Inclusion Criteria:
1. Inpatient wards, defined as wards used to manage inpatients, in the five Ministry of National Guard Health Affairs (MNGHA) hospitals, Kingdom of Saudi Arabia
Exclusion Criteria:
Patient level inclusion and exclusion criteria
Inclusion Criteria:
Exclusion Criteria:
1. No commitment for full life support on the time of arrival to the study ward
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Intensive Care Department, King Abdulaziz Medical City, National Guard Health Affairs | Riyadh | 11426 | Saudi Arabia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39658862 | Derived | 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. | |
| 34809672 |
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| ID | Term |
|---|---|
| D018805 | Sepsis |
| ID | Term |
|---|---|
| D007239 | Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
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| Imam Abdulrahman Al Faisal Hospital - Dammam |
| UNKNOWN |
Stepped-wedge Cluster Randomized Controlled Trial
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The electronic alert will be masked on the control wards.
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| ICU-free days | In the first 90 days | 90 Day |
| Critical care response team activation | Critical care response team activation within 90 days | 90 Day |
| Cardiac arrest | Cardiac arrest within 90 days | 90 Day |
| The need for mechanical ventilation, vasopressor therapy, and incident renal replacement therapy | Within 90 days | 90 Day |
| Antibiotic-free days | Antibiotic-free days within 90 days | 90 Day |
| The acquisition of MDROs | The percentage of patients with MDROs within 90 days | 90 Day |
| Clostridium difficile infection | The percentage of patients with clostridium difficile infection within 90 days | 90 Day |
| Derived |
| 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. |
| 34635151 | Derived | 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. |
| D013568 |
| Pathological Conditions, Signs and Symptoms |