SepsisSCREENNCT04078594
Electronic Early Notification of Sepsis in Hospitalized Ward Patients
A study testing sepsis e-alert in people with Sepsis, run by King Abdullah International Medical Research Center at 1 site in Saudi Arabia.
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… Read more about this study
- Who is it for?
- Ages 14 years and older
- Conditions the study is for
- Sepsis
- What is being tested?
- sepsis e-alert
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65,250 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 1 Oct 2019to 30 Nov 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
- Aged 14 years or older
- Checked in as inpatient status to one of the study ward
Who cannot join
- 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
- 1. No commitment for full life support on the time of arrival to the study ward
Trial locations and contacts
1 site in 1 country.
Saudi Arabia1 site
Intensive Care Department, King Abdulaziz Medical City, National Guard Health Affairs
Riyadh, 11426
About this study
Official title: Stepped-wedge Cluster Randomized Controlled Trial of Electronic Early Notification of Sepsis in Hospitalized Ward Patients (SCREEN)
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.
Read the 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.
- Conditions
- Sepsis
- Being tested
- sepsis e-alert
- Keywords
- sepsis, ward patients, Screening, qSOFA
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sepsis e-alertOther
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
| Study group | Role | What they receive |
|---|---|---|
| Experimental wards | Experimental | Active sepsis e-alert Receives: Other: sepsis e-alert |
| Contol wards | No intervention | Masked sepsis e-alert. The wards will have masked sepsis e-alert. |
What is being measured
The primary outcome is the main question the study is designed to answer.
All-cause hospital mortality by day 90
Percentage of all-cause hospital mortality
Measured: 90 Day
Secondary outcomes (9)
Hospital length of stay
Censored at 90 days
Measured: 90 Day
Transfer to ICU
ICU admission within 90 days
Measured: 90 Day
ICU-free days
In the first 90 days
Measured: 90 Day
Critical care response team activation
Critical care response team activation within 90 days
Measured: 90 Day
Cardiac arrest
Cardiac arrest within 90 days
Measured: 90 Day
The need for mechanical ventilation, vasopressor therapy, and incident renal replacement therapy
Within 90 days
Measured: 90 Day
Antibiotic-free days
Antibiotic-free days within 90 days
Measured: 90 Day
The acquisition of MDROs
The percentage of patients with MDROs within 90 days
Measured: 90 Day
Clostridium difficile infection
The percentage of patients with clostridium difficile infection within 90 days
Measured: 90 Day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2019
- Study start1 Oct 2019
- Primary completion30 Aug 2021
- Study completion30 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for SepsisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Stepped-wedge Cluster Randomized Controlled Trial
- Masking
- None (open label)
- Enrolment
- 65,250 participants (actual)
Sponsor and investigators
- Lead sponsor
- King Abdullah International Medical Research Center
- Sponsor type
- University, hospital or other
- Collaborators
- King Abdulaziz Medical City, Jeddah, Prince Mohammed Bin Abdul Aziz Hospital - AlMadinah, King Abdulaziz Hospital, Al Ahsa, Imam Abdulrahman Al Faisal Hospital - Dammam
- Responsible party
- Principal investigator, Dr Yaseen Arabi, King Abdullah International Medical Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04078594
- Sponsor's protocol ID
- RC18/112
- Acronym
- SCREEN
- Status last verified
- Aug 2021
- First submitted
- 17 Jan 2019
- Last updated
- 14 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Arabi YM, Alsaawi A, Alzahrani M, Al Khathaami AM, AlHazme RH, Al Mutrafy A, Al Qarni A, Vishwakarma RK, Al Anazi R, Al Qasim E, Abdukahil SA, Al-Rabeah FK, Al Ghamdi H, Alatassi A, Al-Dorzi HM, Al-Hameed F, Babakr R, Alghamdi AA, Bin Salih S, Alharbi A, AlKatheri ME, Mustafa H, Al-Qahtani S, Al Qahtani S, Alselaim N, Tashkandi N, Alyami AH, Alyousef Z, AlDibasi O, Al-Qahtani AH, Aldawood A, Caswell A, Al Ayadhi N, Al Rehaili H, Al Arfaj A, Al Mubarak H, Alwasaidi T, Zahrani S, Alalawi Y, Alhadab A, Nasser T, Omer T, Al Johani SM, Alajlan A, Sadat M, Alzunitan M, Al Mohrij S; SCREEN Trial Group and the Saudi Critical Care Trials Group. Electronic Sepsis Screening Among Patients Admitted to Hospital Wards: A Stepped-Wedge Cluster Randomized Trial. JAMA. 2025 Mar 4;333(9):763-773. doi: 10.1001/jama.2024.25982.
PubMed 39658862Arabi YM, Vishwakarma RK, Al-Dorzi HM, Al Qasim E, Abdukahil SA, Al-Rabeah FK, Al Ghamdi H, Al Ghamdi E; SCREEN Trial Group. Statistical analysis plan for the Steppedwedge Cluster Randomized trial of Electronic Early Notification of sepsis in hospitalized ward patients (SCREEN). Trials. 2021 Nov 22;22(1):828. doi: 10.1186/s13063-021-05788-3.
PubMed 34809672Arabi YM, Alsaawi A, Al Zahrani M, Al Khathaami AM, AlHazme RH, Al Mutrafy A, Al Qarni A, Al Shouabi A, Al Qasim E, Abdukahil SA, Al-Rabeah FK, Al Ghamdi H, Al Ghamdi E, Alansari M, Abuelgasim KA, Alatassi A, Alchin J, Al-Dorzi HM, Ghamdi AA, Al-Hameed F, Alharbi A, Hussein M, Jastaniah W, AlKatheri ME, AlMarhabi H, Mustafa HT, Jones J, Al-Qahtani S, Qahtani S, Qureshi AS, Salih SB, Alselaim N, Tashkandi N, Vishwakarma RK, AlWafi E, Alyami AH, Alyousef Z; SCREEN Trial Group. Electronic early notification of sepsis in hospitalized ward patients: a study protocol for a stepped-wedge cluster randomized controlled trial. Trials. 2021 Oct 11;22(1):695. doi: 10.1186/s13063-021-05562-5.
PubMed 34635151
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stepped-wedge Cluster Randomized Controlled Trial of Electronic Early Notification of Sepsis in Hospitalized Ward Patients (SCREEN)
- ClinicalTrials.gov ID
- NCT04078594
- Acronym / sponsor ID
- SCREEN / RC18/112
- Conditions
- Sepsis
- Keywords
- sepsis, ward patients, Screening, qSOFA
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65,250 participants (actual)
- Lead sponsor
- King Abdullah International Medical Research CenterUniversity, hospital or other
- Collaborators
- King Abdulaziz Medical City, Jeddah, Prince Mohammed Bin Abdul Aziz Hospital - AlMadinah, King Abdulaziz Hospital, Al Ahsa, Imam Abdulrahman Al Faisal Hospital - Dammam
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 30 Aug 2021 (actual)
- Study completion
- 30 Nov 2022 (actual)
- First posted
- 6 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Stepped-wedge Cluster Randomized Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| Experimental wards | Experimental | Other: sepsis e-alertActive sepsis e-alert |
| Contol wards | No intervention | –Masked sepsis e-alert. The wards will have masked sepsis e-alert. |
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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
- Aged 14 years or older
- Checked in as inpatient status to one of the study ward
Key exclusion criteria (7 listed)
- Cardiology, transplant, pediatric, obstetric wards
- Intensive Care Units and Emergency Department
- Operating rooms
- Outpatients
- Day care wards, endoscopy, outpatient procedure areas, hemodialysis units.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| sepsis e-alertAt 2-each month interval, the e-alert will be activated in five new randomly selected wards, until all wards eventually will have active alert | Other | Experimental wards |
Primary outcome
All-cause hospital mortality by day 90
Time frame: 90 Day
Percentage of all-cause hospital mortality
9 secondary outcomes
Hospital length of stay
Time frame: 90 Day
Transfer to ICU
Time frame: 90 Day
ICU-free days
Time frame: 90 Day
Critical care response team activation
Time frame: 90 Day
Cardiac arrest
Time frame: 90 Day
The need for mechanical ventilation, vasopressor therapy, and incident renal replacement therapy
Time frame: 90 Day
Antibiotic-free days
Time frame: 90 Day
The acquisition of MDROs
Time frame: 90 Day
Clostridium difficile infection
Time frame: 90 Day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2023.
- Derived from this study: PubMed 39658862Arabi YM, Alsaawi A, Alzahrani M, Al Khathaami AM, AlHazme RH, Al Mutrafy A, Al Qarni A, Vishwakarma RK, Al Anazi R, Al Qasim E, Abdukahil SA, Al-Rabeah FK, Al Ghamdi H, Alatassi A, Al-Dorzi HM, Al-Hameed F, Babakr R, Alghamdi AA, Bin Salih S, Alharbi A, AlKatheri ME, Mustafa H, Al-Qahtani S, Al Qahtani S, Alselaim N, Tashkandi N, Alyami AH, Alyousef Z, AlDibasi O, Al-Qahtani AH, Aldawood A, Caswell A, Al Ayadhi N, Al Rehaili H, Al Arfaj A, Al Mubarak H, Alwasaidi T, Zahrani S, Alalawi Y, Alhadab A, Nasser T, Omer T, Al Johani SM, Alajlan A, Sadat M, Alzunitan M, Al Mohrij S; SCREEN Trial Group and the Saudi Critical Care Trials Group. Electronic Sepsis Screening Among Patients Admitted to Hospital Wards: A Stepped-Wedge Cluster Randomized Trial. JAMA. 2025 Mar 4;333(9):763-773. doi: 10.1001/jama.2024.25982.
- Derived from this study: PubMed 34809672Arabi YM, Vishwakarma RK, Al-Dorzi HM, Al Qasim E, Abdukahil SA, Al-Rabeah FK, Al Ghamdi H, Al Ghamdi E; SCREEN Trial Group. Statistical analysis plan for the Steppedwedge Cluster Randomized trial of Electronic Early Notification of sepsis in hospitalized ward patients (SCREEN). Trials. 2021 Nov 22;22(1):828. doi: 10.1186/s13063-021-05788-3.
- Derived from this study: PubMed 34635151Arabi YM, Alsaawi A, Al Zahrani M, Al Khathaami AM, AlHazme RH, Al Mutrafy A, Al Qarni A, Al Shouabi A, Al Qasim E, Abdukahil SA, Al-Rabeah FK, Al Ghamdi H, Al Ghamdi E, Alansari M, Abuelgasim KA, Alatassi A, Alchin J, Al-Dorzi HM, Ghamdi AA, Al-Hameed F, Alharbi A, Hussein M, Jastaniah W, AlKatheri ME, AlMarhabi H, Mustafa HT, Jones J, Al-Qahtani S, Qahtani S, Qureshi AS, Salih SB, Alselaim N, Tashkandi N, Vishwakarma RK, AlWafi E, Alyami AH, Alyousef Z; SCREEN Trial Group. Electronic early notification of sepsis in hospitalized ward patients: a study protocol for a stepped-wedge cluster randomized controlled trial. Trials. 2021 Oct 11;22(1):695. doi: 10.1186/s13063-021-05562-5.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing sepsis e-alert in people with Sepsis, run by King Abdullah International Medical Research Center at 1 site in Saudi Arabia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All-cause hospital mortality by day 90 (time frame: 90 Day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04078594, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2023.