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Impact of a Prehospital Sepsis Protocol on Timely Antibiotic Administration and Subsequent Adverse Events

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Conditions

SepsisSepsis screeningEMS-based screening

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The primary purpose of this study is to evaluate the impact of an Emergency Medical Services (EMS) based sepsis screening and early warning protocol on the timing of early sepsis care in the Emergency Department (ED).

Official Title

A Multicenter, Stepped Wedge, Cluster Randomized Study of a Prehospital Sepsis Protocol and Its Impact on Timely Antibiotic Administration in the Emergency Department and Subsequent Adverse Events

Quick Facts

Study Start:2023-06-27
Study Completion:2025-07-15
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT05502107

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Lowest EMS systolic blood pressure \<110 mmHg
  2. * Highest EMS pulse rate \>90 beats per minute
  3. * Highest EMS respiratory rate \>20 breaths per minute
  4. * EMS transport to a participating study ED/hospital
  5. * At least one of the following present:
  6. * Lowest systolic blood pressure \<90 mmHg
  7. * Age 40 years or greater
  8. * Hot temperature assessment or temp \>38 degrees Celsius
  9. * Oxygen saturation \<90%
  10. * Nursing home patient
  11. * Emergency Medical Dispatch classification = 'sick person'
  1. * Any of the following EMS conditions present:
  2. * Trauma injury
  3. * Cardiac arrest
  4. * Psychiatric emergency
  5. * Toxic ingestion
  6. * Pregnant patient
  7. * Inability to administratively link EMS and ED/hospital records
  8. * Patient left emergency department prior to being evaluated by a medical provider (inability to classify sepsis status)

Contacts and Locations

Principal Investigator

Carmen C Polito, MD, MSc
PRINCIPAL_INVESTIGATOR
Emory University
Jonathan E Sevransky, MD, MHS
PRINCIPAL_INVESTIGATOR
Emory University

Study Locations (Sites)

Emory University Hospital
Atlanta, Georgia, 30322
United States
University of Iowa
Iowa City, Iowa, 52242
United States
Washington University
Saint Louis, Missouri, 63130
United States

Collaborators and Investigators

Sponsor: Emory University

  • Carmen C Polito, MD, MSc, PRINCIPAL_INVESTIGATOR, Emory University
  • Jonathan E Sevransky, MD, MHS, PRINCIPAL_INVESTIGATOR, Emory University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-06-27
Study Completion Date2025-07-15

Study Record Updates

Study Start Date2023-06-27
Study Completion Date2025-07-15

Terms related to this study

Keywords Provided by Researchers

  • Sepsis screening
  • EMS-based screening

Additional Relevant MeSH Terms

  • Sepsis