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Completed

NCT Number: NCT05213923

ED Tracking Sheet Implementation

The purpose of this study is to assess whether implementation of an ED Sepsis Tracking Sheet effects the percentage of goal-directed sepsis criteria met in a tertiary care academic Emergency Department.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

About this study

Sepsis remains a common cause of morbidity and mortality in the hospital setting. Accurate diagnosis and timely initiation of therapy are important drivers of patient-centered outcomes in sepsis management. Compliance with the core measures listed in the surviving sepsis campaign guidelines has been variable.

An ED-specific Sepsis Tracking Sheet (STS) - a tool for implementing and documenting critical actions in sepsis management - was created at our institution by a team of physicians, nurses, and ED pharmacists. Dedicated ED pharmacists were instructed to fill this sheet within one hour of the sepsis-specific best practice advisory (BPA) being activated in the ED. Core measures associated with the one hour and three hour sepsis bundles were tracked and outcomes were compared pre- and post-implementation of the STS.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Over 18 years old
  • Initially evaluated in the DHMC Lebanon Emergency Department
  • Activated sepsis BPA upon initial presentation (triage history consistent with infection combined with 2 or more SIRS criteria? Are these the criteria that trigger our sepsis BPA?)

Exclusion criteria

  • Patients who are transferred to the DHMC Lebanon Emergency Department from another facility
  • Patients with absent data regarding one or more of the goal-directed sepsis criteria
  • Patients who did not initially meet criteria to trigger the sepsis BPA, but developed sepsis later in their hospital course

Treatment and study plan

ED Sepsis Tracking Sheet

Procedure

Implementation of an ED Sepsis Tracking Sheet. This sheet will track time of patient presentation, time of High-Acuity Medical Response (HAMR) page, time of bilateral 18g or larger IV access, time of initial lactate, time two sets of blood cultures were sent, time antibiotics were administered as well as which antibiotics and what dose, time initial IV fluid bolus was completed, time repeat lactate was sent, timing of post-IV-fluid bolus vital signs, as well as the presence of persistent hypotension following this IV fluid bolus and whether or not vasopressors were applied.

Primary outcomes

  1. Percentage of goal-directed sepsis criteria met

    Time frame: Time of ED presentation to the time of in-hospital death or hospital discharge, approximately 2 weeks

    Goal-directed sepsis criteria involve the following: 1) Was an initial lactate obtained? 2) Were two sets of blood cultures sent? 3) Were antibiotics given within one hour of identification of severe sepsis? 4) Was the patient given an initial IV fluid bolus? 5) Was a repeat lactate sent if the initial lactate was elevated? These five criteria will be assessed as "met" or "not met" for each patient. The total of "met" and "not met" criteria will be aggregated across patients. The percentage of goal-directed sepsis criteria met will be calculated as "met" criteria divided by the sum of "met" plus "not met" criteria.

Secondary outcomes

  1. Length of hospital stay

    Time frame: Time of ED presentation to the time of in-hospital death or hospital discharge, approximately 2 weeks

    Time of ED presentation to the time of in-hospital death or hospital discharge, measured in days.

  2. In-hospital mortality

    Time frame: Time of ED presentation to the time of in-hospital death or hospital discharge, approximately 2 weeks

    Death attributed to any cause occurring at any time between the patient's ED presentation and hospital discharge.

Sponsors and collaborators

Lead sponsor

Dartmouth-Hitchcock Medical Center

Other

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jan 28, 2022
Registry last updated
May 19, 2023

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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