SCREEN: Electronic Early Notification of Sepsis in Hospitalized Ward Patients

Sponsor
King Abdullah International Medical Research Center (Other)
Overall Status
Recruiting
CT.gov ID
NCT04078594
Collaborator
King Abdulaziz Medical City, Jeddah (Other), Prince Mohammed Bin Abdul Aziz Hospital - AlMadinah (Other), King Abdulaziz Hospital, Al Ahsa (Other), Imam Abdulrahman Al Faisal Hospital - Dammam (Other)
65,250
1
2
25
2613.2

Study Details

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
  • Other: sepsis e-alert
N/A

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

Study Type:
Interventional
Anticipated Enrollment :
65250 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Stepped-wedge Cluster Randomized Controlled TrialStepped-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 :
Oct 1, 2019
Anticipated Primary Completion Date :
Oct 30, 2021
Anticipated Study Completion Date :
Oct 30, 2021

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

  1. All-cause hospital mortality by day 90 [90 Day]

    Percentage of all-cause hospital mortality

Secondary Outcome Measures

  1. Hospital length of stay [90 Day]

    Censored at 90 days

  2. Transfer to ICU [90 Day]

    ICU admission within 90 days

  3. ICU-free days [90 Day]

    In the first 90 days

  4. Critical care response team activation [90 Day]

    Critical care response team activation within 90 days

  5. Cardiac arrest [90 Day]

    Cardiac arrest within 90 days

  6. The need for mechanical ventilation, vasopressor therapy, and incident renal replacement therapy [90 Day]

    Within 90 days

  7. Antibiotic-free days [90 Day]

    Antibiotic-free days within 90 days

  8. The acquisition of MDROs [90 Day]

    The percentage of patients with MDROs within 90 days

  9. Clostridium difficile infection [90 Day]

    The percentage of patients with clostridium difficile infection within 90 days

Eligibility Criteria

Criteria

Ages Eligible for Study:
14 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No

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

Contacts and Locations

Locations

Site City State Country Postal Code
1 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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
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:
Sep 6, 2019
Last Update Posted:
Sep 5, 2021
Last Verified:
Aug 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Dr Yaseen Arabi, Chairman intensive care unit, King Abdullah International Medical Research Center
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 5, 2021