Electronic Early Notification of Sepsis in Hospitalized Ward Patients (SCREEN)

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ClinicalTrials.gov Identifier: NCT04078594

Recruitment Status : Completed

First Posted : September 6, 2019

Last Update Posted : March 14, 2023

View this study on Beta.ClinicalTrials.gov

Sponsor:

Collaborators:

King Abdulaziz Medical City, Jeddah

Prince Mohammed Bin Abdul Aziz Hospital - AlMadinah

King Abdulaziz Hospital, Al Ahsa

Imam Abdulrahman Al Faisal Hospital - Dammam

Information provided by (Responsible Party):

Dr Yaseen Arabi, King Abdullah International Medical Research Center

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Sepsis	Other: sepsis e-alert	Not Applicable

Detailed Description:

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	65250 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Intervention Model Description:	Stepped-wedge Cluster Randomized Controlled Trial
Masking:	None (Open Label)
Masking Description:	The electronic alert will be masked on the control wards.
Primary Purpose:	Screening
Official Title:	Stepped-wedge Cluster Randomized Controlled Trial of Electronic Early Notification of Sepsis in Hospitalized Ward Patients (SCREEN)
Actual Study Start Date :	October 1, 2019
Actual Primary Completion Date :	August 30, 2021
Actual Study Completion Date :	November 30, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sepsis

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Experimental: Experimental wards Active sepsis e-alert	Other: sepsis e-alert 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
No Intervention: Contol wards Masked sepsis e-alert. The wards will have masked sepsis e-alert.

Outcome Measures

Primary Outcome Measures :

All-cause hospital mortality by day 90 [ Time Frame: 90 Day ]
Percentage of all-cause hospital mortality

Secondary Outcome Measures :

Hospital length of stay [ Time Frame: 90 Day ]
Censored at 90 days
Transfer to ICU [ Time Frame: 90 Day ]
ICU admission within 90 days
ICU-free days [ Time Frame: 90 Day ]
In the first 90 days
Critical care response team activation [ Time Frame: 90 Day ]
Critical care response team activation within 90 days
Cardiac arrest [ Time Frame: 90 Day ]
Cardiac arrest within 90 days
The need for mechanical ventilation, vasopressor therapy, and incident renal replacement therapy [ Time Frame: 90 Day ]
Within 90 days
Antibiotic-free days [ Time Frame: 90 Day ]
Antibiotic-free days within 90 days
The acquisition of MDROs [ Time Frame: 90 Day ]
The percentage of patients with MDROs within 90 days
Clostridium difficile infection [ Time Frame: 90 Day ]
The percentage of patients with clostridium difficile infection within 90 days

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	14 Years and older (Child, Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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:

Cardiology, transplant, pediatric, obstetric wards
Intensive Care Units and Emergency Department
Operating rooms
Outpatients
Day care wards, endoscopy, outpatient procedure areas, hemodialysis units.

Patient level inclusion and exclusion criteria

Inclusion Criteria:

Aged 14 years or older
Checked in as inpatient status to one of the study ward

Exclusion Criteria:

1. No commitment for full life support on the time of arrival to the study ward

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04078594

Locations

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Saudi Arabia
Intensive Care Department, King Abdulaziz Medical City, National Guard Health Affairs
Riyadh, Saudi Arabia, 11426

Sponsors and Collaborators

King Abdullah International Medical Research Center

King Abdulaziz Medical City, Jeddah

Prince Mohammed Bin Abdul Aziz Hospital - AlMadinah

King Abdulaziz Hospital, Al Ahsa

Imam Abdulrahman Al Faisal Hospital - Dammam

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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.

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Responsible Party:	Dr Yaseen Arabi, Chairman intensive care unit, King Abdullah International Medical Research Center
ClinicalTrials.gov Identifier:	NCT04078594
Other Study ID Numbers:	RC18/112
First Posted:	September 6, 2019 Key Record Dates
Last Update Posted:	March 14, 2023
Last Verified:	August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	No

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Studies a U.S. FDA-regulated Drug Product:	No
Studies a U.S. FDA-regulated Device Product:	No

Keywords provided by Dr Yaseen Arabi, King Abdullah International Medical Research Center:


sepsis ward patients Screening qSOFA

Additional relevant MeSH terms:

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Sepsis Toxemia Infections	Systemic Inflammatory Response Syndrome Inflammation Pathologic Processes

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