ShockNCT00596921
Bedside Ultrasound Measurement of the Inferior Vena Cava Correlates to Central Venous Pressure
An observational study of Shock and Hypovolemia, run by Brooke Army Medical Center.
Trial summary
This study proposes to examine the correlation of central venous pressure to measures of the diameter of the inferior vena cava as determined by bedside ultrasonography. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Shock, Hypovolemia, Hypervolemia
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- 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: Hospitalized patients with central venous monitoring in place.
Who may be able to join
- CVP or right heart catheter that is already in place and functioning properly
Who cannot join
- Supine position or placement of ultrasound probe on abdomen is contraindicated.
Trial locations and contacts
No sites are listed yet.
Robert A De Lorenzo, MD contact
About this study
This study proposes to examine the correlation of central venous pressure to measures of the diameter of the inferior vena cava as determined by bedside ultrasonography.
Read the detailed description
Central venous pressure (CVP) is a key physiologic estimate of preload, which in turn helps define the vascular fluid status. It is a particularly important parameter to measure in critically ill and injured patients who may require resuscitation. Unfortunately, measurement of the CVP requires invasive central venous catheters which can be difficult or time-consuming to insert. A non-invasive means of inferring the CVP would provide clinicians with an alternative. Preliminary data suggests that the diameter of the vena cava may reflect the CVP. Ultrasonography can provide reliable measures of internal body structures including the vena cava, and therefore may be useful in this regard. Collecting simultaneous values of vena cava diameter and CVPs will allow for the identification and quantification of correlation.
- Conditions
- Shock, Hypovolemia, Hypervolemia
- Keywords
- Ultrasonography, Central Venous Pressure, Noninvasive monitoring, Shock, Resuscitation
- Medical subject headings
- Shock, Hypovolemia, Edema
What is being measured
The primary outcome is the main question the study is designed to answer.
Bedside ultrasound measurement of the diameter of the inferior vena cava and simultaneously measured central venous pressure.
Measured: Cross-sectional
Secondary outcomes (1)
Anatomic view and phase of respiration at the time of measurements.
Measured: Cross-sectional
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2008 (estimated)
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
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brooke Army Medical Center
- Sponsor type
- US federal agency
- Investigators
- Robert A De Lorenzo, MD, Principal investigator, Brooke Army Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00596921
- Sponsor's protocol ID
- C.2008.029
- Other IDs
- CIRO.2008111
- Status last verified
- Jan 2008
- First submitted
- 8 Jan 2008
- Last updated
- 17 Jan 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bedside Ultrasound Measurement of the Inferior Vena Cava Correlates to Central Venous Pressure
- ClinicalTrials.gov ID
- NCT00596921
- Acronym / sponsor ID
- C.2008.029
- Conditions
- Shock, Hypovolemia, Hypervolemia
- Keywords
- Ultrasonography, Central Venous Pressure, Noninvasive monitoring, Shock, Resuscitation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Brooke Army Medical CenterUS federal agency
- First posted
- 17 Jan 2008 (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.
This study proposes to examine the correlation of central venous pressure to measures of the diameter of the inferior vena cava as determined by bedside ultrasonography.
Detailed description
Central venous pressure (CVP) is a key physiologic estimate of preload, which in turn helps define the vascular fluid status. It is a particularly important parameter to measure in critically ill and injured patients who may require resuscitation. Unfortunately, measurement of the CVP requires invasive central venous catheters which can be difficult or time-consuming to insert. A non-invasive means of inferring the CVP would provide clinicians with an alternative. Preliminary data suggests that the diameter of the vena cava may reflect the CVP. Ultrasonography can provide reliable measures of internal body structures including the vena cava, and therefore may be useful in this regard. Collecting simultaneous values of vena cava diameter and CVPs will allow for the identification and quantification of correlation.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Hospitalized patients with central venous monitoring in place.
Key inclusion criteria (1 listed)
- CVP or right heart catheter that is already in place and functioning properly
Key exclusion criteria (1 listed)
- Supine position or placement of ultrasound probe on abdomen is contraindicated.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Bedside ultrasound measurement of the diameter of the inferior vena cava and simultaneously measured central venous pressure.
Time frame: Cross-sectional
1 secondary outcome
Anatomic view and phase of respiration at the time of measurements.
Time frame: Cross-sectional
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2008.
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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.
Robert A De Lorenzo, MD contact
Robert A De Lorenzo, MD principal investigator
Brooke Army Medical Center
Questions about this trial
What is this clinical trial studying?
An observational study of Shock and Hypovolemia, run by Brooke Army Medical Center.
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 1 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: status not confirmed, as of the sponsor's last update on 17 Jan 2008. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Robert A De Lorenzo, MD (210.916.0607), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bedside ultrasound measurement of the diameter of the inferior vena cava and simultaneously measured central venous pressure. (time frame: Cross-sectional). 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 17 Jan 2008.