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

Undifferentiated Shock Clinical Trial

Official title:

Establishing a Tool to Increase the Accuracy of Emergency Physicians Diagnosing Etiologies of Shock

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02164799
• Other study ID #: 2012P-000357
• Status: Completed
• Phase: N/A
• First received: June 13, 2014
• Last updated: June 13, 2014
• Start date: November 2012

Study information

• Verified date: June 2014
• Source: Beth Israel Deaconess Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: CCI
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2500
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Shock
• Undifferentiated Shock

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Beth Israel Deaconess Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Deterioration	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.	This measure will be assessed at the time of physician review after discharge from hospital, on average 2 months after initial ED visit.	No
Primary	Etiology of Shock	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.	Retrospectively, 1 month after enrollment	No
Secondary	In hospital mortality	Death by any cause during hospitalization	This measure will be assessed at the time of physician review after discharge from hospital, on average 2 months after initial ED visit.	No