Use of Ultrasonography to Determine Fluid-responsiveness for Shock in a Population of Intensive Care Unit Patients

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by University of Chicago
Sponsor:
Information provided by (Responsible Party):
University of Chicago
ClinicalTrials.gov Identifier:
NCT01680770
First received: June 18, 2012
Last updated: March 12, 2014
Last verified: March 2014
  Purpose

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.


Condition
Hypotension

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Use of Ultrasonography to Determine Fluid-responsiveness for Shock in a Population of Intensive Care Unit Patients

Resource links provided by NLM:


Further study details as provided by University of Chicago:

Primary Outcome Measures:
  • Fluid Responder vs. Non-responder [ Time Frame: pre-fluid challenge baseline and post-fluid challenge (approximately 1 hour) ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Inferior vena cava diameter and respiratory variation [ Time Frame: pre-fluid challenge baseline and post-fluid challenge (approximately 1 hour) ] [ Designated as safety issue: No ]
    pre-fluid Inferior vena cava diameter and Inferior vena cava respiratory variations will be correlated to fluid responsiveness

  • subclavian vein diameter and respiratory variation [ Time Frame: pre-fluid challenge baseline and post-fluid challenge (approximately 1 hour) ] [ Designated as safety issue: No ]
    pre-fluid subclavian diameter and subclavian respiratory variations will be correlated to fluid responsiveness

  • pulse pressure variation [ Time Frame: pre-fluid challenge baseline and post-fluid challenge (approximately 1 hour) ] [ Designated as safety issue: No ]
    pre-fluid pulse pressure variation will be correlated to fluid responsiveness

  • central venous pressure (CVP) and CVP respiratory variation [ Time Frame: pre-fluid challenge baseline and post-fluid challenge (approximately 1 hour) ] [ Designated as safety issue: No ]
    pre-fluid CVP and CVP respiratory variations will be correlated to fluid responsiveness

  • pulmonary capillary wedge pressure (PCWP) and respiratory variations of PCWP [ Time Frame: pre-fluid challenge baseline and post-fluid challenge (approximately 1 hour) ] [ Designated as safety issue: No ]
    pre-fluid PCWP and PCWP respiratory variations will be correlated to fluid responsiveness

  • Possible views of echocardiogram [ Time Frame: pre-fluid challenge baseline and post-fluid challenge (approximately 1 hour) ] [ Designated as safety issue: No ]
    Determine percentage of which echocardiographic views are obtainable in a broad population of patients with shock and correlate to patient characteristics

  • Concurrence with cardiologist interpretation [ Time Frame: pre-fluid challenge baseline and post-fluid challenge (approximately 1 hour) ] [ Designated as safety issue: No ]
    Determine the rate at which cardiologist concurs with intensivist interpretation of echocardiographic images.


Estimated Enrollment: 124
Study Start Date: July 2010
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Hypotensive patients in 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Adult Intensive Care Unit Patients

Criteria

Inclusion Criteria:

  1. Adult patients (> 18 years old) admitted to the intensive care unit.
  2. Decision by clinicians to give intravenous fluids for volume expansion.
  3. Decision by clinicians to obtain central venous access.

Exclusion Criteria:

  1. Patients with known chronic right heart failure syndromes.
  2. Patients with terminal conditions in whom aggressive care will not be pursued.
  3. Patients with a history of left bundle branch block.
  4. Patients will not be excluded on the basis of sex, race, or ethnicity.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01680770

Contacts
Contact: Shruti Patel, MD 773-702-3804 shruti.patel@uchospitals.edu
Contact: Kress P John, MD 773-702-6404 jkress@medicine.bsd.uchicago.edu

Locations
United States, Illinois
The University of Chicago Medical Center Recruiting
Chicago, Illinois, United States, 60637
Contact: Shruti Patel, MD    773-702-3804    spatel@medicine.bsd.uchicago.edu   
Principal Investigator: John P Kress, MD         
Sub-Investigator: Shruti Patel, MD         
Sponsors and Collaborators
University of Chicago
Investigators
Principal Investigator: Kress P John, MD University of Chicago
  More Information

No publications provided

Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT01680770     History of Changes
Other Study ID Numbers: 10-566B
Study First Received: June 18, 2012
Last Updated: March 12, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Chicago:
shock
transthoracic echocardiography
critical care

Additional relevant MeSH terms:
Hypotension
Shock
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on July 23, 2014