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

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ClinicalTrials.gov Identifier: NCT02164851
Recruitment Status : Unknown
Verified January 2020 by Nathan Shapiro, Beth Israel Deaconess Medical Center.
Recruitment status was:  Active, not recruiting
First Posted : June 17, 2014
Last Update Posted : January 18, 2020
Sponsor:
Information provided by (Responsible Party):
Nathan Shapiro, Beth Israel Deaconess Medical Center

Tracking Information
First Submitted Date June 13, 2014
First Posted Date June 17, 2014
Last Update Posted Date January 18, 2020
Actual Study Start Date November 28, 2012
Estimated Primary Completion Date January 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 13, 2014)
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. ]
Composite in hospital endpoint: 1) acute renal failure (Creatinine 2x baseline or new hemodialysis), non-elective intubation, vasopressor requirement, mortality.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: June 13, 2014)
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. ]
In-hospital mortality.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Non-Invasive Shock: Differentiating Shock in the Emergency Department
Official Title Non-Invasive Shock: Differentiating Shock in the Emergency Department
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.
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 Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
50 mLs of whole blood will be collected at enrollment for biomarker analysis
Sampling Method Non-Probability Sample
Study Population Patients found to have shock and "near-shock" physiology in the emergency department.
Condition
  • Shock
  • Infection
  • Inflammation
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: June 13, 2014)
500
Original Estimated Enrollment Same as current
Estimated Study Completion Date January 2021
Estimated Primary Completion Date January 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 100 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02164851
Other Study ID Numbers 2013P000004
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Current Responsible Party Nathan Shapiro, Beth Israel Deaconess Medical Center
Original Responsible Party Daniel Henning, Beth Israel Deaconess Medical Center, Instructor of Medicine
Current Study Sponsor Beth Israel Deaconess Medical Center
Original Study Sponsor Same as current
Collaborators Not Provided
Investigators
Principal Investigator: Nathan I Shapiro, MD, MPH Beth Israel Deaconess Medical Center
PRS Account Beth Israel Deaconess Medical Center
Verification Date January 2020