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Sonography in Hypotension and Cardiac Arrest in the Emergency Department. (SHoC-ED 1)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01419106
Recruitment Status : Unknown
Verified June 2015 by Paul Atkinson, Horizon Health Network.
Recruitment status was:  Recruiting
First Posted : August 17, 2011
Last Update Posted : June 19, 2015
Information provided by (Responsible Party):

Study Description
Brief Summary:
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, 30 day and discharge mortality).

Condition or disease Intervention/treatment
Hypotension Point of Care Ultrasound Shock Device: Ultrasound (A point of care ultrasound protocol)

  Show Detailed Description

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: SHoC-ED 1: Sonography in Hypotension and Cardiac Arrest in the Emergency Department.
Study Start Date : August 2011
Estimated Primary Completion Date : December 2015
Estimated Study Completion Date : July 2016

Arms and Interventions

Arm Intervention/treatment
No Intervention: Control
This arm of the study will NOT receive point of care ultrasound. They will receive all other standard care implemented during their visit to the ED (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 point of care ultrasound. The protocol they will receive is the ACES protocol (described above).
Device: Ultrasound (A point of care ultrasound protocol)
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.

Outcome Measures

Primary Outcome Measures :
  1. Patient Mortality Rates (7-day, 30 Day or Hospital Discharge) [ Time Frame: 7-day, 30 Day or Hospital Discharge ]
    Determine the proportion of patients living at 7-day, 30 Day or Hospital Discharge

Secondary Outcome Measures :
  1. Time taken to appropriate intervention [ Time Frame: Within 8 hours ]
    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.

  2. Unexpected change in diagnosis [ Time Frame: First hour ]
    If ED 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.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01419106

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

Canada, Manitoba
University of Manitoba Recruiting
Winnipeg, Manitoba, Canada
Contact: Chau Pham, MD       chaupham1@hotmail.com   
Principal Investigator: Chau Pham, MD         
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
GF Jooste Hospital Active, not recruiting
Manenberg, Cape Town, South Africa, 7764
Tygerberg Hospital Active, not recruiting
Cape Town, Western Cape, South Africa
Khayelitsha Hospital Active, not recruiting
Cape Town, South Africa
Sponsors and Collaborators
Horizon Health Network
University of Cape Town
University of Stellenbosch
Dalhousie University
University of Manitoba
University of Saskatchewan
Harvard University
University of British Columbia
Royal College of Emergency Medicine
Canadian Association of Emergency Physicians
Saint Göran Hospital
University of Michigan
Principal Investigator: James D Milne, MD (Student) Dalhousie Medical School
Principal Investigator: Paul Atkinson, MD Saint John Regional Hospital, Horizon Health Network
Study Director: Jacqueline Fraser, BN Saint John Regional Hospital, Horizon Health Network
More Information

Additional Information:
Responsible Party: Paul Atkinson, Dr. Paul Atkinson, Professor, Department of Emergency Medicine, Horizon Health Network
ClinicalTrials.gov Identifier: NCT01419106     History of Changes
Other Study ID Numbers: 2011-1590
First Posted: August 17, 2011    Key Record Dates
Last Update Posted: June 19, 2015
Last Verified: June 2015

Keywords provided by Paul Atkinson, Horizon Health Network:
Emergency care
Point of care Ultrasound

Additional relevant MeSH terms:
Heart Arrest
Disease Attributes
Pathologic Processes
Heart Diseases
Cardiovascular Diseases
Vascular Diseases