Clinical trial NCT04078594: Electronic Early Notification of Sepsis in Hospitalized Ward Patients
Official title: Stepped-wedge Cluster Randomized Controlled Trial of Electronic Early Notification of Sepsis in Hospitalized Ward Patients (SCREEN)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sepsis
Keywords: sepsis
ward patients
Screening
qSOFA
Lead sponsor: King Abdullah International Medical Research Center
Sponsor class: OTHER
Collaborators: name: King Abdulaziz Medical City, Jeddah
name: Prince Mohammed Bin Abdul Aziz Hospital - AlMadinah
name: King Abdulaziz Hospital, Al Ahsa
name: Imam Abdulrahman Al Faisal Hospital - Dammam
First posted: 2019-09-06
Enrollment: 65250
Sex: ALL
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Stepped-wedge Cluster Randomized Controlled Trial
Primary purpose: SCREENING

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.

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.

Eligibility 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:

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.

Patient level inclusion and exclusion criteria

Inclusion Criteria:

1. Aged 14 years or older
2. 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

Primary outcomes:
measure: All-cause hospital mortality by day 90
timeFrame: 90 Day
Secondary outcomes:
measure: Hospital length of stay
timeFrame: 90 Day
measure: Transfer to ICU
timeFrame: 90 Day
measure: ICU-free days
timeFrame: 90 Day
measure: Critical care response team activation
timeFrame: 90 Day
measure: Cardiac arrest
timeFrame: 90 Day
measure: The need for mechanical ventilation, vasopressor therapy, and incident renal replacement therapy
timeFrame: 90 Day
measure: Antibiotic-free days
timeFrame: 90 Day
measure: The acquisition of MDROs
timeFrame: 90 Day
measure: Clostridium difficile infection
timeFrame: 90 Day
Other outcomes:
Locations:
city: Riyadh
country: Saudi Arabia
facility: Intensive Care Department, King Abdulaziz Medical City, National Guard Health Affairs
Study officials:
References:
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.
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.