ShockNCT01981629
The Use of the USCOM Device in Addition to Cardiac Ultrasound in Patients Undergoing Treatment for Undifferentiated Shock
An observational study of Shock, run by Hennepin Healthcare Research Institute at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Shock
- What is being tested?
- USCOM
- Type of treatment
- Medical device
- How many people
- 47 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2012to Aug 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients presenting to the emergency department at an urban county hospital.
Who may be able to join
- 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
Who cannot join
- less than 18 years old
- Pregnant
- Patients in shock due to trauma
Trial locations and contacts
1 site in 1 country.
United States1 site
Hennepin County Medical Center
Minneapolis, Minnesota, 55415
About this study
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.
- Conditions
- Shock
- Being tested
- USCOM
- Keywords
- Shock, USCOM, Cardiac Ultrasound, Emergency Department
- Medical subject headings
- Shock, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
USCOMDevice
The USCOM device will be used in addition to cardiac ultrasound in patients with shock.
| Study group | Role | What they receive |
|---|---|---|
| Shock | Defined by systolic blood pressure less than 95 mmHg or shock index (heart rate/systolic blood pressure) greater than 0.9 Receives: Device: USCOM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiac Output
Cardiac ultrasound findings will be compared to cardiac index and output from the USCOM device
Measured: Twice during ED visit, averaging one hour
Secondary outcomes (1)
Patient outcomes
Data will be collected on outcomes of patients including death, length of ICU stay, length of hospital stay, and diagnosis.
Measured: After emergency department visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2013 (estimated)
- Study startJul 2012
- Primary completionAug 2013
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ShockStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hennepin Healthcare Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Johanna C Moore, MD, Principal investigator, Hennepin Healthcare Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01981629
- Sponsor's protocol ID
- 12-3496
- Status last verified
- Oct 2014
- First submitted
- 24 Oct 2013
- Last updated
- 24 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of the USCOM Device in Addition to Cardiac Ultrasound in Patients Undergoing Treatment for Undifferentiated Shock
- ClinicalTrials.gov ID
- NCT01981629
- Acronym / sponsor ID
- 12-3496
- Conditions
- Shock
- Keywords
- Shock, USCOM, Cardiac Ultrasound, Emergency Department
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Hennepin Healthcare Research InstituteUniversity, hospital or other
- Study start
- Jul 2012
- Primary completion
- Aug 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 11 Nov 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Shock | – | Device: USCOMDefined by systolic blood pressure less than 95 mmHg or shock index (heart rate/systolic blood pressure) greater than 0.9 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients presenting to the emergency department at an urban county hospital.
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (3 listed)
- less than 18 years old
- Pregnant
- Patients in shock due to trauma
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| USCOMThe USCOM device will be used in addition to cardiac ultrasound in patients with shock. | Device | Shock |
Primary outcome
Cardiac Output
Time frame: Twice during ED visit, averaging one hour
Cardiac ultrasound findings will be compared to cardiac index and output from the USCOM device
1 secondary outcome
Patient outcomes
Time frame: After emergency department visit
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Johanna C Moore, MD principal investigator
Hennepin Healthcare Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Shock, run by Hennepin Healthcare Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiac Output (time frame: Twice during ED visit, averaging one hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Oct 2014.