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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04078594
Other study ID # RC18/112
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 1, 2019
Est. completion date November 30, 2022

Study information

Verified date August 2021
Source King Abdullah International Medical Research Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 65250
Est. completion date November 30, 2022
Est. primary completion date August 30, 2021
Accepts healthy volunteers No
Gender All
Age group 14 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Saudi Arabia Intensive Care Department, King Abdulaziz Medical City, National Guard Health Affairs Riyadh

Sponsors (5)

Lead Sponsor Collaborator
King Abdullah International Medical Research Center Imam Abdulrahman Al Faisal Hospital - Dammam, King Abdulaziz Hospital, Al Ahsa, King Abdulaziz Medical City, Jeddah, Prince Mohammed Bin Abdul Aziz Hospital - AlMadinah

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

Type Measure Description Time frame Safety issue
Primary All-cause hospital mortality by day 90 Percentage of all-cause hospital mortality 90 Day
Secondary Hospital length of stay Censored at 90 days 90 Day
Secondary Transfer to ICU ICU admission within 90 days 90 Day
Secondary ICU-free days In the first 90 days 90 Day
Secondary Critical care response team activation Critical care response team activation within 90 days 90 Day
Secondary Cardiac arrest Cardiac arrest within 90 days 90 Day
Secondary The need for mechanical ventilation, vasopressor therapy, and incident renal replacement therapy Within 90 days 90 Day
Secondary Antibiotic-free days Antibiotic-free days within 90 days 90 Day
Secondary The acquisition of MDROs The percentage of patients with MDROs within 90 days 90 Day
Secondary Clostridium difficile infection The percentage of patients with clostridium difficile infection within 90 days 90 Day
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