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Completed

NCT Number: NCT04148989

Effects of Code Sepsis Implementation on Emergency Department (ED) Sepsis Care

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Intermountain Medical Center, Murray, Utah, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

(overall):

  • 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.

Exclusion criteria

(overall):

(1) Trauma patient

Treatment and study plan

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.

Primary outcomes

  1. 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

Secondary outcomes

  1. All-cause 30-day Mortality

    Time frame: 30 days after ED arrival

    Sepsis patient death on or before the 30th day after ED arrival

  2. All-cause 1-year Mortality

    Time frame: 1 year after ED arrival

    Sepsis patient death on or before the 365th day after ED arrival

  3. All-cause In-hospital Mortality

    Time frame: From the time of admission to hospital discharge (up to 1 year, average 14 days)

    Sepsis patient death prior to hospital discharge

  4. Hospital Charges

    Time frame: From the time of admission to hospital discharge (up to 1 year, average 14 days)

    Amount charged to sepsis patient for their medical care during index ED visit and associated hospitalization

  5. Hospital Length of Stay

    Time frame: From the time of admission to hospital discharge (up to 1 year, average 14 days)

    Length of time from sepsis patients' ED arrival until hospital discharge

Other outcomes

  1. Antibiotic Utilization'

    Time frame: Up to 24 hours from ED arrival (an average of 6 hours)

    Fraction of all ED patients receiving antibiotics within 24 hours of ED arrival

  2. Adverse Effects of Antibiotics (Sepsis Patients)

    Time frame: From the time of ED arrival to hospital discharge (up to 1 year, average 14 days)

    Measured as the fraction of sepsis patients with a discharge diagnosis code consistent with anaphylaxis or with an adverse reaction to antibiotics

  3. Adverse Effect of Antibiotics (All ED Patients)

    Time frame: From the time of ED arrival to hospital discharge (up to 1 year, average 14 days)

    Measured as the fraction of all ED patients with a discharge diagnosis code consistent with anaphylaxis or with an adverse reaction to antibiotics

  4. New Onset Clostridium Difficile Colitis Incidence (Sepsis Patients)

    Time frame: Beginning 72 hours after ED arrival to 90 days after ED arrival

    Incidence of positive stool test for Clostridium difficile colitis between 72 hours and 90 days after ED arrival among ED sepsis patients and (2) all ED patients.

  5. New Onset Clostridium Difficile Colitis Incidence (All ED Patients)

    Time frame: Beginning 72 hours after ED arrival to 90 days after ED arrival.

    Incidence of positive stool test for Clostridium difficile colitis between 72 hours and 90 days after ED arrival among all ED patients.

  6. Antibiotic Overtreatment Rate

    Time frame: Up to 24 hours from ED arrival (an average of 6 hours)

    Fraction of ED patients with a primary hospital discharge diagnosis of congestive heart failure or venous thromboembolism and no discharge diagnosis consistent with infection who received antibiotics in the ED

  7. Antibiotic Spectrum (Sepsis Patients)

    Time frame: Up to 24 hours from ED arrival (an average of 6 hours)

    Total antibiotic spectrum score for all unique antibiotics administered in first 24 hours using antibiotic spectrum scoring system developed by Stenehjem et al. (Clin Infect Dis 2016;63:1273-1280). Individual antibiotics have spectrum scores of 1 to 5, with the total score resulting from summation of the spectrum scores for each unique antibiotic administered during the first 24 hours. Minimum total 24-hour score is therefore 1 (administration of a single, minimum-spectrum antibiotic), with no maximum score. Higher values represent treatment with antibiotics with a broader spectrum.

  8. Antibiotic Spectrum (All ED Patients)

    Time frame: Up to 24 hours from ED arrival (an average of 6 hours)

    Total antibiotic spectrum score for all unique antibiotics administered in first 24 hours using antibiotic spectrum scoring system developed by Stenehjem et al. (Clin Infect Dis 2016;63:1273-1280). Individual antibiotics have spectrum scores of 1 to 5, with the total score resulting from summation of the spectrum scores for each unique antibiotic administered during the first 24 hours. Minimum total 24-hour score is therefore 1 (administration of a single, minimum-spectrum antibiotic), with no maximum score. Higher values represent treatment with antibiotics with a broader spectrum.

Sponsors and collaborators

Lead sponsor

Intermountain Health Care, Inc.

Other

Collaborators

  • National Institute of General Medical Sciences (NIGMS)

Registry information

Acronym: Code Sepsis

Important dates

Study start
2018
Primary completion
2023
Study completion
2023
First posted
Nov 4, 2019
Registry last updated
Mar 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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