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CompletedNCT02164851NISUpdated Oct 29, 2024

Non-Invasive Shock: Differentiating Shock in the Emergency Department

An observational study in Shock, Infection and Inflammation, sponsored by Beth Israel Deaconess Medical Center. Completed at 1 site in United States. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2024-10-29.

Sponsored by Beth Israel Deaconess Medical Center · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
500
Ages
18 Years to 100 Years
Sex
All
01

Study summary

The goal of this study is to compare the characteristics of echocardiography and different monitoring devices in shock patients, the relationship of device parameters to biomarkers associated with shock, and determine if these any of these add clinical utility when predicting the cause of shock. We will perform a prospective, observational study of patients found to have shock physiology in the ED and follow them to determine the final shock category and ultimate outcomes.

Read the detailed description

Shock is a common final pathway for many disease states, occurring when oxygen and nutrient delivery are not sufficient to maintain normal cellular function. The incidence of shock in the emergency department (ED) is approximated to be 1-3% of ED patients(1), and it carries a high mortality, ranging from 20-50% depending on the underlying cause of shock(2). Early recognition and treatment of shock significantly improves outcomes in critically ill patients(2, 3), and so the majority of efforts to this point have focused on identifying patients with shock.

The many etiologies of shock may be grouped into several broader categories: cardiogenic, distributive, hemorrhagic, hypovolemic, anaphylactic, and neurogenic. These categories cause shock through different mechanisms, but they have a significant amount of clinical overlap (4-7), making differentiating the cause of shock challenging for the emergency provider. While some overlap also exists between the treatments for these categories, several have vastly different therapeutic approaches. Since the early treatment of shock influences outcomes(2, 3, 8, 9), identifying the correct etiology to treat should logically impact outcomes as well, although this has not been studied in shock patients. However, Moore, et al., did show that physicians were only able to correctly identify the cause of hypotension in 25% of hypotensive patients in the ED, speaking to both the difficulty in diagnosing shock etiologies and the high percentage of patients with undifferentiated shock(10).

Recently, a number of different devices and biomarkers have been suggested to have clinical utility in differentiating shock and guiding resuscitation(11-13). These devices have potential to aid in the differentiation of shock.

We will conduct a prospective, observational study of patients found to have shock and "near-shock" physiology in the emergency department. We will identify patients meeting our inclusion criteria which will identify shock and "near shock" patients. Inclusion criteria will include: HR > 120, SBP \< 90, or a shock index (HR/SBP) > 1 for at least five minutes. Patients that do meet vital sign requirements, but have a lactate > 4 mmol/L, will also be included.

Enrolled patients will undergo physiologic assessments using echocardiography, Microscan, Non-invasive cardiac output monitor (NICOM), and extremity temperature device, as well as a blood draw for biomarker assessment.

02

Conditions studied

  • Shock
  • Infection
  • Inflammation

Keywords

  • shock, emergencies, inflammation, infection
  • pathologic process
03

In context

Shock

922 studies on the registry are indexed under Shock; 172 are open to participants now.

This study's planned enrollment of 500 is above the median of 93 across 355 observational studies indexed under Shock.

Browse Shock studies →

Lead sponsor

Beth Israel Deaconess Medical Center is the lead sponsor of 565 studies on the registry; 81 are open to participants now.

Of its 75 completed or terminated interventional studies of FDA-regulated products, 62 (83%) have results posted.

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

04

Who can participate

Ages eligible
18 Years to 100 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients found to have shock and "near-shock" physiology in the emergency department.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 18 years old
  • determined to have shock physiology, which will be defined by vital sign requirements including SBP \< 90 despite appropriate resuscitation (e.g 2 L of normal saline) for at least five minutes.
  • Patients that do meet vital sign requirements and vasopressor initiation will also be included

Exclusion criteria

Exclusion Criteria:

  • patients determined to have atrial fibrillation with rapid ventricular response or supraventricular tachycardia, and the patient is discharged when the ventricular rate is corrected.
  • Patients will also be excluded if found to have to alcohol withdrawal, intoxication, or psychiatric agitation without organic cause.
  • Patients with SBP \< 90 mm/hg who have been documented to have chronic low blood pressure and their blood pressure is at baseline
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
500 participants (estimated)
Patient registry
No
Biospecimen retention
Samples without dna
06

What researchers measure

Primary outcomes

  1. Deterioration

    Composite in hospital endpoint: 1) acute renal failure (Creatinine 2x baseline or new hemodialysis), non-elective intubation, vasopressor requirement, 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.

Secondary outcomes

  1. Mortality

    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.

07

Study locations

1 site
  • Beth Israel Deaconess Medical Center
    Boston, Massachusetts 02215, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 29, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02164851
Responsible party
Nathan Shapiro (Instructor of Medicine, Beth Israel Deaconess Medical Center) — Principal investigator
First posted
Jun 17, 2014
Start date
Nov 28, 2012
Primary completion
Jan 1, 2020
Completion
Jan 1, 2020
Last update
Oct 29, 2024

Study contacts

Nathan I Shapiro, MD, MPH
principal investigator · Beth Israel Deaconess Medical Center

Oversight

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

Not currently enrolling

This study is completed, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.

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