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Completed

NCT Number: NCT02164799

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Etiology of Shock

    Time frame: 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 outcomes

  1. In hospital 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.

    Death by any cause during hospitalization

Other outcomes

  1. Deterioration

    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.

    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.

Sponsors and collaborators

Lead sponsor

Beth Israel Deaconess Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2013
First posted
Jun 17, 2014
Registry last updated
Jun 17, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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