Sepsis Clinical Trial
— SCREENOfficial title:
Stepped-wedge Cluster Randomized Controlled Trial of Electronic Early Notification of Sepsis in Hospitalized Ward Patients (SCREEN)
Verified date | August 2021 |
Source | King Abdullah International Medical Research Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Saudi Arabia | Intensive Care Department, King Abdulaziz Medical City, National Guard Health Affairs | Riyadh |
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 |
Saudi Arabia,
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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