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. (see Contacts and Locations)
Verified November 2013 by Horizon Health Network
Sponsor:
Information provided by (Responsible Party):
Paul Atkinson, Horizon Health Network
ClinicalTrials.gov Identifier:
NCT01419106
First received: August 15, 2011
Last updated: November 4, 2013
Last verified: November 2013
  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:


Further study details as provided by Horizon Health Network:

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: October 2014
Estimated Primary Completion Date: July 2014 (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.

  Show Detailed Description

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 Recruiting
Saskatoon, Saskatchewan, Canada, S7K 0M7
Contact: Paul Olszynski, MD       pao292@mail.usask.ca   
Principal Investigator: Paul Olszynski, MD         
South Africa
GF Jooste Hospital Recruiting
Manenberg, Cape Town, South Africa, 7764
Contact: Kamil Vallabh, MBBCh(Wits) , FCEM(SA)    +27828756897    kamil.vallabh@gmail.com   
Principal Investigator: Kamil Vallabh, MBBCh(Wits) FCEM(SA)         
Tygerberg Hospital Recruiting
Cape Town, Western Cape, South Africa
Contact: Hein Lampbrecht, MD       heinlamp@telkomsa.net   
Principal Investigator: Hein Lampbrecht, MD         
Khayelitsha Hospital Recruiting
Cape Town, South Africa
Contact: Sa'ad Lahri, MBChB(UCT), FCEM(SA)    0213604600    slahri7@gmail.com   
Principal Investigator: Sa'ad Lahri, MBChB(UCT), FCEM(SA)         
Sponsors and Collaborators
Horizon Health Network
Investigators
Principal Investigator: James D Milne, MD (Student) Dalhousie Medical School
Principal Investigator: Paul Atkinson, MD Horizon Health Network
  More Information

No publications provided

Responsible Party: Paul Atkinson, Dr. Paul Atkinson, Head of Research, Department of Emergency Medicine, Saint John Regional Hospital, Horizon Health Network
ClinicalTrials.gov Identifier: NCT01419106     History of Changes
Other Study ID Numbers: 2011-1590
Study First Received: August 15, 2011
Last Updated: November 4, 2013
Health Authority: Canada: Canadian Institutes of Health Research

Additional relevant MeSH terms:
Hypotension
Cardiovascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on October 22, 2014