Electronic Early Notification of Sepsis in Hospitalized Ward Patients

Not Applicable

Completed

• Conditions: Sepsis
• Interventions: Other: sepsis e-alert

• Registration Number: NCT04078594
• Lead Sponsor: King Abdullah International Medical Research Center

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.

Study Timeline

• Study First Submitted: 2019-01-17
• Study First Submitted QC: 2019-09-01
• Study First Posted: 2019-09-06
• Study Start: 2019-10-01
• Status Verified: 2021-08
• Primary Completion: 2021-08-30
• Study Completion: 2022-11-30
• Last Update Submitted: 2023-03-12
• Last Update Posted: 2023-03-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 65250

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental wards	sepsis e-alert	Active sepsis e-alert

Primary Outcome Measures

Name	Time	Method
All-cause hospital mortality by day 90	90 Day	Percentage of all-cause hospital mortality

Secondary Outcome Measures

Name	Time	Method
The need for mechanical ventilation, vasopressor therapy, and incident renal replacement therapy	90 Day	Within 90 days
Antibiotic-free days	90 Day	Antibiotic-free days within 90 days
Clostridium difficile infection	90 Day	The percentage of patients with clostridium difficile infection within 90 days
Cardiac arrest	90 Day	Cardiac arrest within 90 days
The acquisition of MDROs	90 Day	The percentage of patients with MDROs within 90 days
ICU-free days	90 Day	In the first 90 days
Critical care response team activation	90 Day	Critical care response team activation within 90 days
Hospital length of stay	90 Day	Censored at 90 days
Transfer to ICU	90 Day	ICU admission within 90 days

Trial Locations

Locations (1)

Intensive Care Department, King Abdulaziz Medical City, National Guard Health Affairs; 🇸🇦 Riyadh, Saudi Arabia