An observational study in Hypotension, sponsored by University of Chicago. Active, not recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-08-17.
Sponsored by University of Chicago · Observational
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.
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.
1,003 studies on the registry are indexed under Hypotension; 173 are open to participants now.
This study's planned enrollment of 124 is above the median of 84 across 294 observational studies indexed under Hypotension.
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Of its 99 completed or terminated interventional studies of FDA-regulated products, 68 (69%) have results posted.
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Adult Intensive Care Unit Patients
Exclusion Criteria:
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.
Time frame: pre-fluid challenge baseline and post-fluid challenge (approximately 1 hour)
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: pre-fluid challenge baseline and post-fluid challenge (approximately 1 hour)
Plan to share: No
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This study is active, not recruiting, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.
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University of Chicago