Electronic Early Notification of Sepsis in Hospitalized Ward Patients

NCT ID: NCT04078594

Last Updated: 2023-03-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

65250 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-01

Study Completion Date

2022-11-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Sepsis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Stepped-wedge Cluster Randomized Controlled Trial
Primary Study Purpose

SCREENING

Blinding Strategy

NONE

The electronic alert will be masked on the control wards.

Study Groups

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Experimental wards

Active sepsis e-alert

Group Type EXPERIMENTAL

sepsis e-alert

Intervention Type 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

Contol wards

Masked sepsis e-alert.

The wards will have masked sepsis e-alert.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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

Intervention Type OTHER

Eligibility Criteria

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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


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

Exclusion Criteria

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



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

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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King Abdulaziz Medical City, Jeddah

UNKNOWN

Sponsor Role collaborator

Prince Mohammed Bin Abdul Aziz Hospital - AlMadinah

UNKNOWN

Sponsor Role collaborator

King Abdulaziz Hospital, Al Ahsa

UNKNOWN

Sponsor Role collaborator

Imam Abdulrahman Al Faisal Hospital - Dammam

UNKNOWN

Sponsor Role collaborator

King Abdullah International Medical Research Center

OTHER

Sponsor Role lead

Responsible Party

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Dr Yaseen Arabi

Chairman intensive care unit

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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

Riyadh, , Saudi Arabia

Site Status

Countries

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Saudi Arabia

References

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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.

Reference Type DERIVED
PMID: 39658862 (View on PubMed)

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.

Reference Type DERIVED
PMID: 34809672 (View on PubMed)

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.

Reference Type DERIVED
PMID: 34635151 (View on PubMed)

Other Identifiers

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RC18/112

Identifier Type: -

Identifier Source: org_study_id

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