NCT01981629

Brief Summary

Currently, bedside ultrasound (US) is performed routinely in emergency department (ED) patients with undifferentiated shock to help guide resuscitation. Previously, it has never been possible to measure cardiac output on patients in the ED. Our clinical question looks at whether the USCOM device gives clinically relevant information in addition to ED cardiac US in patients with shock.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
47

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2012

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2013

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 24, 2013

Completed
18 days until next milestone

First Posted

Study publicly available on registry

November 11, 2013

Completed
Last Updated

October 24, 2014

Status Verified

October 1, 2014

Enrollment Period

1.1 years

First QC Date

October 24, 2013

Last Update Submit

October 23, 2014

Conditions

Shock

Keywords

ShockUSCOMCardiac UltrasoundEmergency Department

Outcome Measures

Primary Outcomes (1)

  • Cardiac Output

    Cardiac ultrasound findings will be compared to cardiac index and output from the USCOM device

    Twice during ED visit, averaging one hour

Secondary Outcomes (1)

  • Patient outcomes

    After emergency department visit

Study Arms (1)

Shock

Defined by systolic blood pressure less than 95 mmHg or shock index (heart rate/systolic blood pressure) greater than 0.9

Device: USCOM

Interventions

USCOMDEVICE

The USCOM device will be used in addition to cardiac ultrasound in patients with shock.

Shock

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients presenting to the emergency department at an urban county hospital.

You may qualify if:

  • Patients in shock, as defined by systolic blood pressure less than 95 mmHg or shock index (heart rate/systolic blood pressure) greater than 0.9

You may not qualify if:

  • less than 18 years old
  • Pregnant
  • Patients in shock due to trauma

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hennepin County Medical Center

Minneapolis, Minnesota, 55415, United States

Location

MeSH Terms

Conditions

ShockEmergencies

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsDisease Attributes

Study Officials

  • Johanna C Moore, MD

    Hennepin Healthcare Research Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 24, 2013

First Posted

November 11, 2013

Study Start

July 1, 2012

Primary Completion

August 1, 2013

Study Completion

August 1, 2013

Last Updated

October 24, 2014

Record last verified: 2014-10

Locations

US(1)