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

Completed

• Conditions: Undifferentiated Shock

• Registration Number: NCT02164799
• Lead Sponsor: Beth Israel Deaconess Medical Center

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.

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 Timeline

• Study Start: 2012-11
• Primary Completion: 2013-09
• Status Verified: 2014-06
• Study First Submitted: 2014-06-13
• Study First Submitted QC: 2014-06-13
• Last Update Submitted: 2014-06-13
• Study First Posted: 2014-06-17
• Last Update Posted: 2014-06-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2500

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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