Sonography in Hypotension and Cardiac Arrest in the Emergency Department.

NCT01419106 | Completed DMC

• 1 other identifier: 2011-1590
• Study Type: interventional
• Target: 273
• Locations: 2 countries
• Sites: 6

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).

Conditions

Hypotension; Point of Care Ultrasound; Shock

Keywords

Hypotension; Emergency care; Point of care Ultrasound; Shock

Outcome Measures

Primary Outcomes (1)

• Patient Mortality Rates (7-day, 30 Day or Hospital Discharge)

  Determine the proportion of patients living at 7-day, 30 Day or Hospital Discharge

  7-day, 30 Day or Hospital Discharge

Secondary Outcomes (2)

• Time taken to appropriate intervention

  Within 8 hours

• Unexpected change in diagnosis

  First hour

Study Arms (2)

Control

NO INTERVENTION

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.

Ultrasound

EXPERIMENTAL

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)

Interventions

Ultrasound (A point of care ultrasound protocol) DEVICE

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.

Ultrasound

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Horizon Health Network: lead
• University of Cape Town: collaborator
• University of Stellenbosch: collaborator
• Dalhousie University: collaborator
• University of Manitoba: collaborator
• University of Saskatchewan: collaborator
• Harvard University: collaborator
• University of British Columbia: collaborator
• Royal College of Emergency Medicine: collaborator
• Canadian Association of Emergency Physicians: collaborator
• Saint Göran Hospital: collaborator
• University of Michigan: collaborator

Study Sites (6)

University of Manitoba

Winnipeg, Manitoba, Canada

Location

Saint John Regional Hospital

Saint John, New Brunswick, E2L 4L2, Canada

Location

Saskatoon Health Region

Saskatoon, Saskatchewan, S7K 0M7, Canada

Location

GF Jooste Hospital

Manenberg, Cape Town, 7764, South Africa

Location

Tygerberg Hospital

Cape Town, Western Cape, South Africa

Location

Khayelitsha Hospital

Cape Town, South Africa

Location

Related Publications (1)

• Atkinson PR, Milne J, Diegelmann L, Lamprecht H, Stander M, Lussier D, Pham C, Henneberry R, Fraser JM, Howlett MK, Mekwan J, Ramrattan B, Middleton J, van Hoving DJ, Peach M, Taylor L, Dahn T, Hurley S, MacSween K, Richardson LR, Stoica G, Hunter S, Olszynski PA, Lewis DA. Does Point-of-Care Ultrasonography Improve Clinical Outcomes in Emergency Department Patients With Undifferentiated Hypotension? An International Randomized Controlled Trial From the SHoC-ED Investigators. Ann Emerg Med. 2018 Oct;72(4):478-489. doi: 10.1016/j.annemergmed.2018.04.002. Epub 2018 Jun 2.

  PMID: 29866583 RESULT

MeSH Terms

Conditions

Hypotension; Shock

Interventions

Ultrasonography

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• James D Milne, MD (Student)

  Dalhousie Medical School

  PRINCIPAL INVESTIGATOR

• Paul Atkinson, MD

  Saint John Regional Hospital, Horizon Health Network

  PRINCIPAL INVESTIGATOR

• Jacqueline Fraser, BN

  Saint John Regional Hospital, Horizon Health Network

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Paul Atkinson, Professor, Department of Emergency Medicine

Study Record Dates

• First Submitted: August 15, 2011
• First Posted: August 17, 2011
• Study Start: August 1, 2011
• Primary Completion: June 1, 2018
• Study Completion: June 1, 2018
• Last Updated: August 28, 2018

Record last verified: 2018-08

Locations

CA (3); ZA (3)