SHoC-ED 1: A Study on the Effects of Ultrasound on Hypotensive Patients in the ER and Patient Outcomes
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).
|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|
- 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).
- 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.
|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)|
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.
This group WILL receive ultrasound. The protocol they will receive is the ACES protocol (described above).
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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Please refer to this study by its ClinicalTrials.gov identifier: NCT01419106
|Contact: Paul Atkinson, MD||1 506 343-0850||Paul.Atkinson@Horizonnb.ca|
|Contact: James D Milne, MD (Student)||1 506 email@example.com|
|Canada, New Brunswick|
|Saint John Regional Hospital||Recruiting|
|Saint John, New Brunswick, Canada, E2L 4L2|
|Contact: Paul Atkinson, MD firstname.lastname@example.org|
|Contact: Jacky Fraser, BN email@example.com|
|Principal Investigator: Paul Atkinson, MD|
|Saskatoon Health Region||Recruiting|
|Saskatoon, Saskatchewan, Canada, S7K 0M7|
|Contact: Paul Olszynski, MD firstname.lastname@example.org|
|Principal Investigator: Paul Olszynski, MD|
|GF Jooste Hospital||Recruiting|
|Manenberg, Cape Town, South Africa, 7764|
|Contact: Kamil Vallabh, MBBCh(Wits) , FCEM(SA) +27828756897 email@example.com|
|Principal Investigator: Kamil Vallabh, MBBCh(Wits) FCEM(SA)|
|Cape Town, Western Cape, South Africa|
|Contact: Hein Lampbrecht, MD firstname.lastname@example.org|
|Principal Investigator: Hein Lampbrecht, MD|
|Cape Town, South Africa|
|Contact: Sa'ad Lahri, MBChB(UCT), FCEM(SA) 0213604600 email@example.com|
|Principal Investigator: Sa'ad Lahri, MBChB(UCT), FCEM(SA)|
|Principal Investigator:||James D Milne, MD (Student)||Dalhousie Medical School|
|Principal Investigator:||Paul Atkinson, MD||Horizon Health Network|