Non-Invasive Shock: Differentiating Shock in the Emergency Department

NCT02164851 | Completed

• 1 other identifier: 2013P000004
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

Shock; Infection; Inflammation

Keywords

shock, emergencies, inflammation, infection; pathologic process

Outcome Measures

Primary Outcomes (1)

• Deterioration

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

  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

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

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Beth Israel Deaconess Medical Center: lead

Study Sites (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

50 mLs of whole blood will be collected at enrollment for biomarker analysis

MeSH Terms

Conditions

Shock; Infections; Inflammation; Emergencies; Pathologic Processes

Condition Hierarchy (Ancestors)

Pathological Conditions, Signs and Symptoms; Disease Attributes

Study Officials

• Nathan I Shapiro, MD, MPH

  Beth Israel Deaconess Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Instructor of Medicine

Study Record Dates

• First Submitted: June 13, 2014
• First Posted: June 17, 2014
• Study Start: November 28, 2012
• Primary Completion: January 1, 2020
• Study Completion: January 1, 2020
• Last Updated: October 29, 2024

Record last verified: 2024-10

Locations

US (1)