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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 12 December 2020
Main ID:  NCT01419106
Date of registration: 15/08/2011
Prospective Registration: No
Primary sponsor: Horizon Health Network
Public title: Sonography in Hypotension and Cardiac Arrest in the Emergency Department. SHoC-ED
Scientific title: SHoC-ED: Sonography in Hypotension and Cardiac Arrest in the Emergency Department.
Date of first enrolment: August 2011
Target sample size: 273
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT01419106
Study type:  Interventional
Study design:  Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Diagnostic. Masking: Single (Outcomes Assessor).  
Phase:  N/A
Countries of recruitment
Canada South Africa
Contacts
Name:     James D Milne, MD (Student)
Address: 
Telephone:
Email:
Affiliation:  Dalhousie Medical School
Name:     Jacqueline Fraser, BN
Address: 
Telephone:
Email:
Affiliation:  Saint John Regional Hospital, Horizon Health Network
Name:     Paul Atkinson, MD
Address: 
Telephone:
Email:
Affiliation:  Saint John Regional Hospital, Horizon Health Network
Key inclusion & exclusion 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)



Age minimum: 19 Years
Age maximum: N/A
Gender: All
Health Condition(s) or Problem(s) studied
Point of Care Ultrasound
Hypotension
Shock
Intervention(s)
Device: Ultrasound (A point of care ultrasound protocol)
Primary Outcome(s)
Patient Mortality Rates (7-day, 30 Day or Hospital Discharge) [Time Frame: 7-day, 30 Day or Hospital Discharge]
Secondary Outcome(s)
Unexpected change in diagnosis [Time Frame: First hour]
Time taken to appropriate intervention [Time Frame: Within 8 hours]
Secondary ID(s)
2011-1590
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Dalhousie University
Harvard University
University of Saskatchewan
University of British Columbia
Canadian Association of Emergency Physicians
University of Manitoba
University of Michigan
Royal College of Emergency Medicine
Saint Göran Hospital
University of Cape Town
University of Stellenbosch
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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