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CompletedNCT02164799Updated Jun 17, 2014

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

An observational study in Undifferentiated Shock, sponsored by Beth Israel Deaconess Medical Center. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-06-17.

Sponsored by Beth Israel Deaconess Medical Center · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
2,500
Ages
18 Years and older
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Undifferentiated Shock

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Keywords

  • Shock
  • Predicting diagnosis
  • Predicting adverse outcomes
03

In context

Shock

916 studies on the registry are indexed under Shock; 176 are open to participants now.

This study's enrollment of 2,500 is above the median of 91 across 346 observational studies indexed under Shock.

Browse Shock studies →

Lead sponsor

Beth Israel Deaconess Medical Center is the lead sponsor of 560 studies on the registry; 80 are open to participants now.

Of its 75 completed or terminated interventional studies of FDA-regulated products, 61 (81%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Emergency Department patients

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

Exclusion Criteria:

  • seizure
  • isolated atrial fibrillation with discharge after rate control achieved
  • discharged from the emergency department
  • intoxication or withdrawal
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
2,500 participants (actual)
Patient registry
No

Groups and cohorts

  • 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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Retrospectively, 1 month after enrollment

Secondary outcomes

  1. In hospital mortality

    Death by any cause during hospitalization

    Time frame: This measure will be assessed at the time of physician review after discharge from hospital, on average 2 months after initial ED visit.

Other outcomes

  1. 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.

    Time frame: This measure will be assessed at the time of physician review after discharge from hospital, on average 2 months after initial ED visit.

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 17, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02164799
Lead sponsor
Beth Israel Deaconess Medical Center
Responsible party
Daniel Henning (Instructor of Medicine, Beth Israel Deaconess Medical Center) — Principal investigator
First posted
Jun 17, 2014
Start date
Nov 2012
Primary completion
Sep 2013
Last update
Jun 17, 2014

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2014. You cannot join it, but the record below documents what was studied.

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