Electronic Early Notification of Sepsis in Hospitalized Ward Patients

NCT04078594 | Completed

• 1 other identifier: RC18/112
• Study Type: interventional
• Target: 65,250
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Sepsis

Keywords

sepsis; ward patients; Screening; qSOFA

Outcome Measures

Primary Outcomes (1)

• All-cause hospital mortality by day 90

  Percentage of all-cause hospital mortality

  90 Day

Secondary Outcomes (9)

• Hospital length of stay

  90 Day

• Transfer to ICU

  90 Day

• ICU-free days

  90 Day

• Critical care response team activation

  90 Day

• Cardiac arrest

  90 Day

Study Arms (2)

Experimental wards

EXPERIMENTAL

Active sepsis e-alert

Other: sepsis e-alert

Contol wards

NO INTERVENTION

Masked sepsis e-alert. The wards will have masked sepsis e-alert.

Interventions

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

Experimental wards

Eligibility Criteria

• Age: 14 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may not qualify if:

• \. Inpatient wards, defined as wards used to manage inpatients, in the five Ministry of National Guard Health Affairs (MNGHA) hospitals, Kingdom of Saudi Arabia
• Cardiology, transplant, pediatric, obstetric wards
• Intensive Care Units and Emergency Department
• Operating rooms
• Outpatients
• Day care wards, endoscopy, outpatient procedure areas, hemodialysis units.
• Aged 14 years or older
• Checked in as inpatient status to one of the study ward
• \. No commitment for full life support on the time of arrival to the study ward

Sponsors & Collaborators

• King Abdullah International Medical Research Center: lead
• King Abdulaziz Medical City, Jeddah: collaborator
• Prince Mohammed Bin Abdul Aziz Hospital - AlMadinah: collaborator
• King Abdulaziz Hospital, Al Ahsa: collaborator
• Imam Abdulrahman Al Faisal Hospital - Dammam: collaborator

Study Sites (1)

Intensive Care Department, King Abdulaziz Medical City, National Guard Health Affairs

Riyadh, 11426, Saudi Arabia

Location

Related Publications (3)

• 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: 39658862 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.

  PMID: 34809672 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.

  PMID: 34635151 DERIVED

MeSH Terms

Conditions

Sepsis

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: The electronic alert will be masked on the control wards.
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chairman intensive care unit

Model Details: Stepped-wedge Cluster Randomized Controlled Trial

Study Record Dates

• First Submitted: January 17, 2019
• First Posted: September 6, 2019
• Study Start: October 1, 2019
• Primary Completion: August 30, 2021
• Study Completion: November 30, 2022
• Last Updated: March 14, 2023

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

SA (1)