HypotensionNCT01680770
Use of Ultrasonography to Determine Fluid-responsiveness for Shock in a Population of Intensive Care Unit Patients
An observational study of Hypotension, run by University of Chicago at 1 site in United States.
Trial summary
The objective of our study is to determine the correlation of transthoracic ultrasonographic indices of fluid responsiveness to changes in direct measures of cardiac output and to compare them to other established predictors of fluid responsiveness such as central venous pressure variation, systolic arterial pressure… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypotension
- How many people
- 124 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2010to Aug 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: Adult Intensive Care Unit Patients
Who may be able to join
- Adult patients (> 18 years old) admitted to the intensive care unit.
- Decision by clinicians to give intravenous fluids for volume expansion.
- Decision by clinicians to obtain central venous access.
Who cannot join
- Patients with known chronic right heart failure syndromes.
- Patients with terminal conditions in whom aggressive care will not be pursued.
- Patients with a history of left bundle branch block.
- Patients will not be excluded on the basis of sex, race, or ethnicity.
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Chicago Medical Center
Chicago, Illinois, 60637
About this study
The objective of our study is to determine the correlation of transthoracic ultrasonographic indices of fluid responsiveness to changes in direct measures of cardiac output and to compare them to other established predictors of fluid responsiveness such as central venous pressure variation, systolic arterial pressure variation and pulse pressure variation in a broad population of patients.
Hypothesis: There will be a significant difference in the inferior vena cava respiratory variation and subclavian vein respiratory variation between responders and non-responders to intravenous fluid challenge in a broad population of patients with shock.
Read the detailed description
Shock is a common occurrence in the intensive care unit (ICU), and the management of this condition frequently requires the administration of intravenous fluids (IVF). Multiple studies have shown that only about 50% of these patients will respond to fluids. The ability to predict which patients will respond is an important tool for clinicians to treat shock while avoiding unnecessary fluid administration in those who are unlikely to respond. This is essential to avoid the adverse effects of fluid loading that can occur.
A number of studies have attempted to determine predictors of volume-responsiveness through various methods, including the use of ultrasonography performed by intensivists, anesthesiologists and emergency medicine physicians. The currently published studies establish predictors of fluid-responsiveness in their populations. However, there has been large variability in the study designs, making it difficult to compare different modalities.
The objective of our study is to determine the correlation of transthoracic ultrasonographic indices of fluid responsiveness to changes in direct measures of cardiac output and to compare them to other established predictors of fluid responsiveness such as central venous pressure variation, systolic arterial pressure variation and pulse pressure variation. Furthermore, we wish to include a broad range of patients with different types of shock in order to determine the generalized applicability of these indices. Additionally, reported success of intensivist-obtained echocardiographic images varies widely in the literature, but most studies do not report which views are most accessible. We plan to study prospectively which views are obtainable and correlate them to patient characteristics.
This would potentially establish echocardiography by an intensivist as a widely applicable, non-invasive, and easily accessible method for determining fluid-responsiveness in a patient with shock. Achievement of this goal would allow clinicians to quickly identify those patients that would respond to fluids and at the same time minimize the administration of fluids to those in whom it is unlikely to benefit.
- Conditions
- Hypotension
- Keywords
- shock, transthoracic echocardiography, critical care
- Medical subject headings
- Hypotension, Shock
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Hypotensive patients in shock | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fluid Responder vs. Non-responder
Patients will be divided into responder and non-responder groups based on an increase in cardiac output of greater than or equal to 15% as measured by thermodilution from a right heart catheter in response to a one liter normal saline fluid bolus.
Measured: pre-fluid challenge baseline and post-fluid challenge (approximately 1 hour)
Secondary outcomes (7)
Inferior vena cava diameter and respiratory variation
pre-fluid Inferior vena cava diameter and Inferior vena cava respiratory variations will be correlated to fluid responsiveness
Measured: pre-fluid challenge baseline and post-fluid challenge (approximately 1 hour)
subclavian vein diameter and respiratory variation
pre-fluid subclavian diameter and subclavian respiratory variations will be correlated to fluid responsiveness
Measured: pre-fluid challenge baseline and post-fluid challenge (approximately 1 hour)
pulse pressure variation
pre-fluid pulse pressure variation will be correlated to fluid responsiveness
Measured: pre-fluid challenge baseline and post-fluid challenge (approximately 1 hour)
central venous pressure (CVP) and CVP respiratory variation
pre-fluid CVP and CVP respiratory variations will be correlated to fluid responsiveness
Measured: pre-fluid challenge baseline and post-fluid challenge (approximately 1 hour)
pulmonary capillary wedge pressure (PCWP) and respiratory variations of PCWP
pre-fluid PCWP and PCWP respiratory variations will be correlated to fluid responsiveness
Measured: pre-fluid challenge baseline and post-fluid challenge (approximately 1 hour)
Possible views of echocardiogram
Determine percentage of which echocardiographic views are obtainable in a broad population of patients with shock and correlate to patient characteristics
Measured: pre-fluid challenge baseline and post-fluid challenge (approximately 1 hour)
Concurrence with cardiologist interpretation
Determine the rate at which cardiologist concurs with intensivist interpretation of echocardiographic images.
Measured: pre-fluid challenge baseline and post-fluid challenge (approximately 1 hour)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2012 (estimated)
- Study startJun 2010
- Primary completionAug 2026 (estimated)
- Study completionAug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypotensionStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 124 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kress P John, MD, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01680770
- Sponsor's protocol ID
- 10-566B
- Status last verified
- Aug 2025
- First submitted
- 18 Jun 2012
- Last updated
- 17 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Ultrasonography to Determine Fluid-responsiveness for Shock in a Population of Intensive Care Unit Patients
- ClinicalTrials.gov ID
- NCT01680770
- Acronym / sponsor ID
- 10-566B
- Conditions
- Hypotension
- Keywords
- shock, transthoracic echocardiography, critical care
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 124 participants (estimated)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Study start
- Jun 2010
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Aug 2026 (estimated)
- First posted
- 7 Sep 2012 (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.
The objective of our study is to determine the correlation of transthoracic ultrasonographic indices of fluid responsiveness to changes in direct measures of cardiac output and to compare them to other established predictors of fluid responsiveness such as central venous pressure variation, systolic arterial pressure variation and pulse pressure variation in a broad population of patients.
Hypothesis: There will be a significant difference in the inferior vena cava respiratory variation and subclavian vein respiratory variation between responders and non-responders to intravenous fluid challenge in a broad population of patients with shock.
Detailed description
Shock is a common occurrence in the intensive care unit (ICU), and the management of this condition frequently requires the administration of intravenous fluids (IVF). Multiple studies have shown that only about 50% of these patients will respond to fluids. The ability to predict which patients will respond is an important tool for clinicians to treat shock while avoiding unnecessary fluid administration in those who are unlikely to respond. This is essential to avoid the adverse effects of fluid loading that can occur.
A number of studies have attempted to determine predictors of volume-responsiveness through various methods, including the use of ultrasonography performed by intensivists, anesthesiologists and emergency medicine physicians. The currently published studies establish predictors of fluid-responsiveness in their populations. However, there has been large variability in the study designs, making it difficult to compare different modalities.
The objective of our study is to determine the correlation of transthoracic ultrasonographic indices of fluid responsiveness to changes in direct measures of cardiac output and to compare them to other established predictors of fluid responsiveness such as central venous pressure variation, systolic arterial pressure variation and pulse pressure variation. Furthermore, we wish to include a broad range of patients with different types of shock in order to determine the generalized applicability of these indices. Additionally, reported success of intensivist-obtained echocardiographic images varies widely in the literature, but most studies do not report which views are most accessible. We plan to study prospectively which views are obtainable and correlate them to patient characteristics.
This would potentially establish echocardiography by an intensivist as a widely applicable, non-invasive, and easily accessible method for determining fluid-responsiveness in a patient with shock. Achievement of this goal would allow clinicians to quickly identify those patients that would respond to fluids and at the same time minimize the administration of fluids to those in whom it is unlikely to benefit.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hypotensive patients in shock | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult Intensive Care Unit Patients
Key inclusion criteria (3 listed)
- Adult patients (> 18 years old) admitted to the intensive care unit.
- Decision by clinicians to give intravenous fluids for volume expansion.
- Decision by clinicians to obtain central venous access.
Key exclusion criteria (4 listed)
- Patients with known chronic right heart failure syndromes.
- Patients with terminal conditions in whom aggressive care will not be pursued.
- Patients with a history of left bundle branch block.
- Patients will not be excluded on the basis of sex, race, or ethnicity.
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
Fluid Responder vs. Non-responder
Time frame: pre-fluid challenge baseline and post-fluid challenge (approximately 1 hour)
Patients will be divided into responder and non-responder groups based on an increase in cardiac output of greater than or equal to 15% as measured by thermodilution from a right heart catheter in response to a one liter normal saline fluid bolus.
7 secondary outcomes
Inferior vena cava diameter and respiratory variation
Time frame: pre-fluid challenge baseline and post-fluid challenge (approximately 1 hour)
subclavian vein diameter and respiratory variation
Time frame: pre-fluid challenge baseline and post-fluid challenge (approximately 1 hour)
pulse pressure variation
Time frame: pre-fluid challenge baseline and post-fluid challenge (approximately 1 hour)
central venous pressure (CVP) and CVP respiratory variation
Time frame: pre-fluid challenge baseline and post-fluid challenge (approximately 1 hour)
pulmonary capillary wedge pressure (PCWP) and respiratory variations of PCWP
Time frame: pre-fluid challenge baseline and post-fluid challenge (approximately 1 hour)
Possible views of echocardiogram
Time frame: pre-fluid challenge baseline and post-fluid challenge (approximately 1 hour)
Concurrence with cardiologist interpretation
Time frame: pre-fluid challenge baseline and post-fluid challenge (approximately 1 hour)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2025.
- Individual participant dataSharing planned: No
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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.
Kress P John, MD principal investigator
University of Chicago
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 Hypotension, run by University of Chicago 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 3 inclusion and 4 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: under way, not looking for participants, as of the sponsor's last update on 17 Aug 2025. 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?
This study is still under way. Results are not available in the source record yet.
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?
Fluid Responder vs. Non-responder (time frame: pre-fluid challenge baseline and post-fluid challenge (approximately 1 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 17 Aug 2025.