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SHoC-ED 1: A Study on the Effects of Ultrasound on Hypotensive Patients in the ER and Patient Outcomes

This study is currently recruiting participants.
Verified March 2012 by Saint John Regional Hospital
Sponsor:
Information provided by (Responsible Party):
Paul Atkinson, Saint John Regional Hospital
ClinicalTrials.gov Identifier:
NCT01419106
First received: August 15, 2011
Last updated: March 27, 2012
Last verified: March 2012
History of Changes
  Purpose

This study is designed to determine if there is any relationship between performing an abdominal ultrasound on patients who present with hypotension and their clinical outcomes (as measured by 7 and 30 day mortality).


Condition Intervention
Hypotension
 Device: Ultrasound

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: SHoC-ED 1 Trial: Sonography in Hypotension and Cardiac Arrest in the Emergency Department 1

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Saint John Regional Hospital:

Primary Outcome Measures:
  • Patient Mortality Rates (7-day) [ Time Frame: 7 days ] [ Designated as safety issue: No ]
    Determine the proportion of patients living at 7 days in each group.

  • Patient Mortality (30-days) [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    Determine the proportion of patients living at 30 days in each group. (This indicates a change in the health status from the 7-day status).


Secondary Outcome Measures:
  • Time taken to appropriate intervention [ Time Frame: Within 8 hours ] [ Designated as safety issue: No ]
    This is a measure that will be done to determine how long after initial diagnosis "appropriate" interventions are taken. This will be done by reviewing the patient's chart, identifying what the ultimate diagnosis for the patient was (resultant of testing that occurs as patient progresses through system), and seeing when propoer intervention was taken.

  • Unexpected change in diagnosis [ Time Frame: First hour ] [ Designated as safety issue: No ]
    If ER physician's expectations prior to performing ultrasound is AAA, but post ultrasound diagnosis is septic shock, this would be an example of an unexpected change in diagnosis. This measure will only be performed in the ultrasound group, as the purpose is to identify how often performing ultrasound will result in diagnosis changes.


Estimated Enrollment: 400
Study Start Date: August 2011
Estimated Study Completion Date: January 2013
Estimated Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Control
This arm of the study will NOT be treated with ultrasound. They will receive all other standard care implemented during a trip to the ER (currently, ultrasound is NOT standard of care). The same blood tests will be done in both groups, as this will offer a means of comparing physiological changes between the two arms.
Experimental: Ultrasound
This group WILL receive ultrasound. The protocol they will receive is the ACES protocol (described above).
 Device: Ultrasound
Bedside ultrasound will be used to view any intraperitoneal bleeding, pleural fluid, cardiac abnormalities, or structural abnormalities of major blood vessels. The results of this test will then be used to determine the best course of treatment for the patient.

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  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 19 years of age or older
  • Systolic Blood Pressure under 100 OR Systolic BP under pulse (up to 120)

Exclusion Criteria:

  • Patients known to be pregnant at time of presentation
  • Necessity of CPR or other advanced life support interventions before enrolment
  • History of significant trauma in past 24 hours
  • A 12 lead diagnostic of acute myocardial infarction
  • Mechanism of shock is clear (i.e. not undifferentiated shock)
  • Previously known diagnosis from other hospital
  • Vagal episode (as cause of hypotension)
  • Low blood pressure not actually being pathologic hypotension (Normal Variant or other)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01419106

Contacts
Contact: Paul Atkinson, MD 1 506 343-0850 Paul.Atkinson@Horizonnb.ca
Contact: James D Milne, MD (Student) 1 506 977-1668 jm502596@dal.ca

Locations
Canada, New Brunswick
Saint John Regional Hospital Recruiting
Saint John, New Brunswick, Canada, E2L 4L2
Contact: Paul Atkinson, MD         pandjatkinson@gmail.com    
Contact: Jacky Fraser, BN         jacqueline.fraser@horizonnb.ca    
Principal Investigator: Paul Atkinson, MD            
Canada, Saskatchewan
Saskatoon Health Region Active, not recruiting
Saskatoon, Saskatchewan, Canada, S7K 0M7
South Africa
Tygerberg Hospital Active, not recruiting
Cape Town, Western Cape, South Africa
Sponsors and Collaborators
Saint John Regional Hospital
Investigators
Principal Investigator: James D Milne, MD (Student) Dalhousie Medical School
Principal Investigator: Paul Atkinson, MD Saint John Regional Hospital
  More Information

No publications provided

Responsible Party: Paul Atkinson, Dr. Paul Atkinson, Head of Research, Department of Emergency Medicine, Saint John Regional Hospital, Saint John Regional Hospital
ClinicalTrials.gov Identifier: NCT01419106     History of Changes
Other Study ID Numbers: 2011-1590
Study First Received: August 15, 2011
Last Updated: March 27, 2012
Health Authority: Canada: Canadian Institutes of Health Research

Additional relevant MeSH terms:
Hypotension
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 22, 2013