The Epidemiology and Approach to Differentiating Etiologies of Shock in the Emergency Department

Sponsor
Beth Israel Deaconess Medical Center (Other)
Overall Status
Completed
CT.gov ID
NCT02164799
Collaborator
(none)
2,500

Study Details

Study Description

Brief Summary

The Shock Tool study is designed to improve the clinical evaluation for differentiating shock in the emergency department. The goal of this study is to evaluate and improve the accuracy of physicians differentiating causes of shock.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Specific Aim #1: To study the epidemiology of shock in the emergency department Hypothesis 1:

    We will better understand shock states if we determine shock etiology among patients presenting to the emergency department in a carefully conducted observational prospective study.

    Specific Aim #2: To determine the accuracy of physician diagnosis for the underlying etiology of shock.

    Hypothesis 2: Physician assessment of the underlying cause of shock is challenging and often inaccurate in the early stages of care in the emergency department.

    Specific Aim #3: To optimize the evidence-based approach to assist in the diagnosis of shock etiology from elements readily available when a patient demonstrates shock physiology in the Emergency Department.

    Hypothesis 3: An evidenced-based, standardized approach to clinical decision making integrating elements of the history, physical exam, and early testing will improve a physician's ability to accurately differentiate etiologies of shock.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    2500 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Establishing a Tool to Increase the Accuracy of Emergency Physicians Diagnosing Etiologies of Shock
    Study Start Date :
    Nov 1, 2012
    Actual Primary Completion Date :
    Sep 1, 2013

    Arms and Interventions

    Arm Intervention/Treatment
    Shock

    Patients found to have persistent hypotension after resuscitation or vasopressor requirement

    Pre-shock

    Patients with markedly abnormal vital signs (Heart Rate (HR)>130, Respiratory Rate (RR)>24, Shock Index >1, Lactate > 4.0mmol/L, or Systolic Blood Pressure (SBP) <90mm/hg) without shock, as defined previously.

    Outcome Measures

    Primary Outcome Measures

    1. Etiology of Shock [Retrospectively, 1 month after enrollment]

      Each patient determined to have shock in the emergency department is given a single diagnosis by a reviewing physician after the hospital course is completed.

    Secondary Outcome Measures

    1. In hospital mortality [This measure will be assessed at the time of physician review after discharge from hospital, on average 2 months after initial ED visit.]

      Death by any cause during hospitalization

    Other Outcome Measures

    1. Deterioration [This measure will be assessed at the time of physician review after discharge from hospital, on average 2 months after initial ED visit.]

      A composite outcome met if any of the following are present during hospitalization: acute renal failure (creatinine 2x baseline or new initiation of dialysis), non-elective intubation, vasopressor requirement, or mortality.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Age 18 years or great

    • For pre-shock cohort: HR > 130, RR>24, Shock index > 1, lactate > 4.0mmol/L, SBP < 90mm/hg)

    • For shock cohort: persistent blood pressure <90mm/hg after resuscitation

    Exclusion Criteria:
    • seizure

    • isolated atrial fibrillation with discharge after rate control achieved

    • discharged from the emergency department

    • intoxication or withdrawal

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Beth Israel Deaconess Medical Center

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Daniel Henning, Instructor of Medicine, Beth Israel Deaconess Medical Center
    ClinicalTrials.gov Identifier:
    NCT02164799
    Other Study ID Numbers:
    • 2012P-000357
    First Posted:
    Jun 17, 2014
    Last Update Posted:
    Jun 17, 2014
    Last Verified:
    Jun 1, 2014
    Keywords provided by Daniel Henning, Instructor of Medicine, Beth Israel Deaconess Medical Center
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jun 17, 2014