SepsisCode SepsisNCT04148989
Effects of Code Sepsis Implementation on Emergency Department (ED) Sepsis Care
A study testing Code Sepsis protocol (full implementation) in people with Sepsis, run by Intermountain Health Care, Inc. at 3 sites in United States.
Trial summary
Sepsis is a life-threatening complication of infection that can be difficult to recognize and treat promptly. Timely administration of antibiotics for emergency department (ED) patients with sepsis is challenging. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sepsis
- What is being tested?
- Code Sepsis protocol (full implementation)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180,402 participants
- Where
- 3 sitesUnited States
- Study dates
- 13 Nov 2018to 28 Dec 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult (age ≥18 years)
- ED patient at Intermountain Medical Center, Utah Valley Hospital, Dixie Regional Medical Center
- Arrival to study emergency department (ED) during study period of 11/13/2018 to 2/12/2021.
Who cannot join
- Trauma patient
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Intermountain Medical Center
Murray, Utah, 84107
Utah Valley Hospital
Provo, Utah, 84604
Dixie Regional Medical Center
St. George, Utah, 84790
About this study
Sepsis is a life-threatening complication of infection that can be difficult to recognize and treat promptly. Timely administration of antibiotics for emergency department (ED) patients with sepsis is challenging. The goal of this study is to determine the potential effectiveness and unintended consequences of reorganizing ED care for patients with suspected sepsis.
- Conditions
- Sepsis
- Being tested
- Code Sepsis protocol (full implementation)
- Keywords
- Sepsis, Clinical Protocols, Emergency Medicine
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Code Sepsis protocol (full implementation)Other
Implementation of a coordinated, structured, multidisciplinary team-based protocol for initial evaluation and treatment of ED patients with suspected sepsis.
| Study group | Role | What they receive |
|---|---|---|
| Pre-implementation usual care (intervention site) | No intervention | Adult patients age ≥18 years who receive usual care after presenting to the ED of the intervention hospital emergency department before implementation of sepsis care reorganization (Code Sepsis implementation). The primary analysis will focus on the subset of patients with sepsis. |
| Code Sepsis post-implementation (intervention site) | Experimental | Adult patients age ≥18 years presenting to the ED of the intervention hospital emergency department after implementation of sepsis care reorganization (Code Sepsis implementation). The primary analysis will focus on the subset of patients with sepsis. Receives: Other: Code Sepsis protocol (full implementation) |
| Pre-implementation usual care (control sites) | No intervention | Adult patients age ≥18 years who receive usual care after presenting to the ED of the control hospital emergency department before implementation of sepsis care reorganization (Code Sepsis implementation) at the intervention hospital. The primary analysis will focus on the subset of patients with sepsis. |
| Post-implementation usual care (control sites) | No intervention | Adult patients age ≥18 years who receive usual care after presenting to the ED of the control hospital emergency department after implementation of sepsis care reorganization (Code Sepsis implementation) at the intervention hospital. The primary analysis will focus on the subset of patients with sepsis. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Door-to-antibiotic Time
Time from sepsis patients' emergency department arrival to intravenous (or equivalent) antibiotic initiation
Measured: Up to 24 hours from ED arrival (an average of 3 hours)
Secondary outcomes (5)
All-cause 30-day Mortality
Sepsis patient death on or before the 30th day after ED arrival
Measured: 30 days after ED arrival
All-cause 1-year Mortality
Sepsis patient death on or before the 365th day after ED arrival
Measured: 1 year after ED arrival
All-cause In-hospital Mortality
Sepsis patient death prior to hospital discharge
Measured: From the time of admission to hospital discharge (up to 1 year, average 14 days)
Hospital Charges
Amount charged to sepsis patient for their medical care during index ED visit and associated hospitalization
Measured: From the time of admission to hospital discharge (up to 1 year, average 14 days)
Hospital Length of Stay
Length of time from sepsis patients' ED arrival until hospital discharge
Measured: From the time of admission to hospital discharge (up to 1 year, average 14 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2019
- Study start13 Nov 2018
- Primary completion23 Jan 2023
- Study completion28 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)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
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- Patients presenting to the intervention emergency department after implementation of the care reorganization intervention - "Code Sepsis protocol" - will be compared to patients presenting prior to the intervention. Patients presenting to control emergency departments will receive usual care both before and after Code Sepsis implementation and are included in this study to control for changes in intervention-site outcomes over time unrelated to the tested intervention.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 180,402 participants (actual)
Sponsor and investigators
- Lead sponsor
- Intermountain Health Care, Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of General Medical Sciences (NIGMS)
- Responsible party
- Principal investigator, Ithan Peltan, Intermountain Health Care, Inc.
- Investigators
- Ithan Peltan, MD, Principal investigator, Intermountain Health Care, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04148989
- Sponsor's protocol ID
- 1051053
- Other IDs
- K23GM129661
- Acronym
- Code Sepsis
- Status last verified
- Feb 2024
- First submitted
- 31 Oct 2019
- Last updated
- 5 Mar 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: In order to protect patient privacy and comply with relevant regulations, identified data will be unavailable. Requests for deidentified data from qualified researchers with appropriate ethics board approvals and relevant data use agreements will be processed by the Intermountain Office of Research, officeofresearch@imail.org.
Publications
Peltan ID, Bledsoe JR, Jacobs JR, Groat D, Klippel C, Adamson M, Hooper GA, Tinker NJ, Foster RA, Stenehjem EA, Moores Todd TD, Balls A, Avery J, Brunson G, Jones J, Bair J, Dorais A, Samore MH, Hough CL, Brown SM. Effectiveness and Safety of an Emergency Department Code Sepsis Protocol: A Pragmatic Clinical Trial. Ann Am Thorac Soc. 2024 Nov;21(11):1560-1571. doi: 10.1513/AnnalsATS.202403-286OC.
PubMed 38996086
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Code Sepsis Implementation on Emergency Department (ED) Sepsis Care
- ClinicalTrials.gov ID
- NCT04148989
- Acronym / sponsor ID
- Code Sepsis / 1051053
- Conditions
- Sepsis
- Keywords
- Sepsis, Clinical Protocols, Emergency Medicine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180,402 participants (actual)
- Lead sponsor
- Intermountain Health Care, Inc.University, hospital or other
- Collaborators
- National Institute of General Medical Sciences (NIGMS)
- Study start
- 13 Nov 2018 (actual)
- Primary completion
- 23 Jan 2023 (actual)
- Study completion
- 28 Dec 2023 (actual)
- First posted
- 4 Nov 2019 (actual)
- Results
- Posted 5 Mar 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Sepsis is a life-threatening complication of infection that can be difficult to recognize and treat promptly. Timely administration of antibiotics for emergency department (ED) patients with sepsis is challenging. The goal of this study is to determine the potential effectiveness and unintended consequences of reorganizing ED care for patients with suspected sepsis.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
- Model description
- Patients presenting to the intervention emergency department after implementation of the care reorganization intervention - "Code Sepsis protocol" - will be compared to patients presenting prior to the intervention. Patients presenting to control emergency departments will receive usual care both before and after Code Sepsis implementation and are included in this study to control for changes in intervention-site outcomes over time unrelated to the tested intervention.
| Arm | Type | Receives |
|---|---|---|
| Pre-implementation usual care (intervention site) | No intervention | –Adult patients age ≥18 years who receive usual care after presenting to the ED of the intervention hospital emergency department before implementation of sepsis care reorganization (Code Sepsis implementation). The primary analysis will focus on the subset of patients with sepsis. |
| Code Sepsis post-implementation (intervention site) | Experimental | Other: Code Sepsis protocol (full implementation)Adult patients age ≥18 years presenting to the ED of the intervention hospital emergency department after implementation of sepsis care reorganization (Code Sepsis implementation). The primary analysis will focus on the subset of patients with sepsis. |
| Pre-implementation usual care (control sites) | No intervention | –Adult patients age ≥18 years who receive usual care after presenting to the ED of the control hospital emergency department before implementation of sepsis care reorganization (Code Sepsis implementation) at the intervention hospital. The primary analysis will focus on the subset of patients with sepsis. |
| Post-implementation usual care (control sites) | No intervention | –Adult patients age ≥18 years who receive usual care after presenting to the ED of the control hospital emergency department after implementation of sepsis care reorganization (Code Sepsis implementation) at the intervention hospital. The primary analysis will focus on the subset of patients with sepsis. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult (age ≥18 years)
- ED patient at Intermountain Medical Center, Utah Valley Hospital, Dixie Regional Medical Center
- Arrival to study emergency department (ED) during study period of 11/13/2018 to 2/12/2021.
Key exclusion criteria (1 listed)
- Trauma patient
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 |
|---|---|---|
| Code Sepsis protocol (full implementation)Implementation of a coordinated, structured, multidisciplinary team-based protocol for initial evaluation and treatment of ED patients with suspected sepsis. | Other | Code Sepsis post-implementation (intervention site) |
Primary outcome
Door-to-antibiotic Time
Time frame: Up to 24 hours from ED arrival (an average of 3 hours)
Time from sepsis patients' emergency department arrival to intravenous (or equivalent) antibiotic initiation
5 secondary outcomes
All-cause 30-day Mortality
Time frame: 30 days after ED arrival
All-cause 1-year Mortality
Time frame: 1 year after ED arrival
All-cause In-hospital Mortality
Time frame: From the time of admission to hospital discharge (up to 1 year, average 14 days)
Hospital Charges
Time frame: From the time of admission to hospital discharge (up to 1 year, average 14 days)
Hospital Length of Stay
Time frame: From the time of admission to hospital discharge (up to 1 year, average 14 days)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38996086Peltan ID, Bledsoe JR, Jacobs JR, Groat D, Klippel C, Adamson M, Hooper GA, Tinker NJ, Foster RA, Stenehjem EA, Moores Todd TD, Balls A, Avery J, Brunson G, Jones J, Bair J, Dorais A, Samore MH, Hough CL, Brown SM. Effectiveness and Safety of an Emergency Department Code Sepsis Protocol: A Pragmatic Clinical Trial. Ann Am Thorac Soc. 2024 Nov;21(11):1560-1571. doi: 10.1513/AnnalsATS.202403-286OC.
- Individual participant dataSharing planned: Yes. In order to protect patient privacy and comply with relevant regulations, identified data will be unavailable. Requests for deidentified data from qualified researchers with appropriate ethics board approvals and relevant data use agreements will be processed by the Intermountain Office of Research, officeofresearch@imail.org.
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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.
Ithan Peltan, MD principal investigator
Intermountain Health Care, Inc.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Code Sepsis protocol (full implementation) in people with Sepsis, run by Intermountain Health Care, Inc. at 3 sites in United States.
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 1 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 5 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. 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?
Yes. Results are posted in the registry (first posted 5 Mar 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Door-to-antibiotic Time (time frame: Up to 24 hours from ED arrival (an average of 3 hours)). 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 NCT04148989, which also lists 1 linked publication.
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 5 Mar 2024.