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Code Sepsis Protocol for Emergency Sepsis Care (Code Sepsis Trial)

N/A
Waitlist Available
Led By Ithan Peltan, MD
Research Sponsored by Intermountain Health Care, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up beginning 72 hours after ed arrival to 90 days after ed arrival.
Awards & highlights

Code Sepsis Trial Summary

This trial will test a new way of organizing emergency care for patients with sepsis, to see if it is more effective than the current standard of care.

Who is the study for?
This trial is for adults over 18 who arrive at certain emergency departments in Utah during the study period. It's focused on patients with suspected sepsis, a serious infection complication. Trauma patients are not eligible to participate.Check my eligibility
What is being tested?
The study is testing the 'Code Sepsis protocol' which aims to reorganize how emergency departments respond to suspected sepsis cases, potentially improving timely treatment and outcomes.See study design
What are the potential side effects?
Since this trial involves organizational changes rather than drugs or medical procedures, traditional side effects are not applicable. However, there may be unintended consequences of changing ED protocols that will be monitored.

Code Sepsis Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~beginning 72 hours after ed arrival to 90 days after ed arrival
This trial's timeline: 3 weeks for screening, Varies for treatment, and beginning 72 hours after ed arrival to 90 days after ed arrival for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Door-to-antibiotic Time
Secondary outcome measures
All-cause 1-year Mortality
All-cause 30-day Mortality
All-cause In-hospital Mortality
+2 more
Other outcome measures
Adverse Effect of Antibiotics (All ED Patients)
Adverse Effects of Antibiotics (Sepsis Patients)
Antibiotic Overtreatment Rate
+5 more

Code Sepsis Trial Design

4Treatment groups
Experimental Treatment
Active Control
Group I: Code Sepsis post-implementation (intervention site)Experimental Treatment1 Intervention
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.
Group II: Pre-implementation usual care (intervention site)Active Control1 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.
Group III: Pre-implementation usual care (control sites)Active Control1 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.
Group IV: Post-implementation usual care (control sites)Active Control1 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.

Find a Location

Who is running the clinical trial?

National Institute of General Medical Sciences (NIGMS)NIH
268 Previous Clinical Trials
68,358 Total Patients Enrolled
19 Trials studying Sepsis
7,581 Patients Enrolled for Sepsis
Intermountain Health Care, Inc.Lead Sponsor
137 Previous Clinical Trials
1,782,708 Total Patients Enrolled
7 Trials studying Sepsis
4,789 Patients Enrolled for Sepsis
Ithan Peltan, MDPrincipal InvestigatorIntermountain Health Care, Inc.
1 Previous Clinical Trials
1,001 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Effects of Code Sepsis Implementation on Emergency Department (ED) Sepsis Care
Ithan Peltan 2018. "Effects of Code Sepsis Implementation on Emergency Department (ED) Sepsis Care". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04148989.
~28115 spots leftby Apr 2025
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