Skip to main content
OpenTrials
Completed

NCT Number: NCT04078594

Electronic Early Notification of Sepsis in Hospitalized Ward Patients

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Sepsis Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Systemic Inflammatory Response Syndrome

Age range

14 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Riyadh, 11426, Saudi Arabia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Ward level inclusion and exclusion criteria

Inclusion criteria

  • 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

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

Treatment and study plan

sepsis e-alert

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

Primary outcomes

  1. All-cause hospital mortality by day 90

    Time frame: 90 Day

    Percentage of all-cause hospital mortality

Secondary outcomes

  1. Hospital length of stay

    Time frame: 90 Day

    Censored at 90 days

  2. Transfer to ICU

    Time frame: 90 Day

    ICU admission within 90 days

  3. ICU-free days

    Time frame: 90 Day

    In the first 90 days

  4. Critical care response team activation

    Time frame: 90 Day

    Critical care response team activation within 90 days

  5. Cardiac arrest

    Time frame: 90 Day

    Cardiac arrest within 90 days

  6. The need for mechanical ventilation, vasopressor therapy, and incident renal replacement therapy

    Time frame: 90 Day

    Within 90 days

  7. Antibiotic-free days

    Time frame: 90 Day

    Antibiotic-free days within 90 days

  8. The acquisition of MDROs

    Time frame: 90 Day

    The percentage of patients with MDROs within 90 days

  9. Clostridium difficile infection

    Time frame: 90 Day

    The percentage of patients with clostridium difficile infection within 90 days

Sponsors and collaborators

Lead sponsor

King Abdullah International Medical Research Center

Other

Collaborators

  • Imam Abdulrahman Al Faisal Hospital - Dammam
  • King Abdulaziz Hospital, Al Ahsa
  • King Abdulaziz Medical City, Jeddah
  • Prince Mohammed Bin Abdul Aziz Hospital - AlMadinah

Registry information

Official study title

Stepped-wedge Cluster Randomized Controlled Trial of Electronic Early Notification of Sepsis in Hospitalized Ward Patients (SCREEN)

Acronym: SCREEN

Important dates

Study start
2019
Primary completion
2021
Study completion
2022
First posted
Sep 6, 2019
Registry last updated
Mar 14, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.