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

NCT ID: NCT02164799

Last Updated: 2014-06-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

2500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-11-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Undifferentiated Shock

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Shock

Patients found to have persistent hypotension after resuscitation or vasopressor requirement

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Beth Israel Deaconess Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Daniel Henning

Instructor of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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2012P-000357

Identifier Type: -

Identifier Source: org_study_id

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