NIS: Non-Invasive Shock: Differentiating Shock in the Emergency Department

Sponsor
Beth Israel Deaconess Medical Center (Other)
Overall Status
Unknown status
CT.gov ID
NCT02164851
Collaborator
(none)
500
1
97.1
5.1

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase

    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.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    500 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Prospective
    Official Title:
    Non-Invasive Shock: Differentiating Shock in the Emergency Department
    Actual Study Start Date :
    Nov 28, 2012
    Anticipated Primary Completion Date :
    Jan 1, 2021
    Anticipated Study Completion Date :
    Jan 1, 2021

    Outcome Measures

    Primary Outcome Measures

    1. Deterioration [This measure will be assessed at the time of physician review after discharge from hospital, on average 2 months after initial ED visit.]

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

    Secondary Outcome Measures

    1. Mortality [This measure will be assessed at the time of physician review after discharge from hospital, on average 2 months after initial ED visit.]

      In-hospital mortality.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 100 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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:
    • 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Beth Israel Deaconess Medical Center Boston Massachusetts United States 02215

    Sponsors and Collaborators

    • Beth Israel Deaconess Medical Center

    Investigators

    • Principal Investigator: Nathan I Shapiro, MD, MPH, Beth Israel Deaconess Medical Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Nathan Shapiro, Instructor of Medicine, Beth Israel Deaconess Medical Center
    ClinicalTrials.gov Identifier:
    NCT02164851
    Other Study ID Numbers:
    • 2013P000004
    First Posted:
    Jun 17, 2014
    Last Update Posted:
    Jan 18, 2020
    Last Verified:
    Jan 1, 2020
    Keywords provided by Nathan Shapiro, Instructor of Medicine, Beth Israel Deaconess Medical Center
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jan 18, 2020