Non-Invasive Shock: Differentiating Shock in the Emergency Department

Inflammation Clinical Trial

— NIS  

Official title:

Non-Invasive Shock: Differentiating Shock in the Emergency Department

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02164851
• Other study ID #: 2013P000004
• Status: Active, not recruiting
• Start date: November 28, 2012
• Est. completion date: January 2021

Study information

• Verified date: January 2020
• Source: Beth Israel Deaconess Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 500
• Est. completion date: January 2021
• Est. primary completion date: January 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Emergencies
• Infection
• Inflammation
• Shock

Locations

Country	Name	City	State
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Beth Israel Deaconess Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Mortality	In-hospital mortality.	This measure will be assessed at the time of physician review after discharge from hospital, on average 2 months after initial ED visit.