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

NCT01680770 | Active Not Recruiting DMC

• 1 other identifier: 10-566B
• Study Type: observational
• Target: 124
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Hypotension

Keywords

shock; transthoracic echocardiography; critical care

Outcome Measures

Primary Outcomes (1)

• 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.

  pre-fluid challenge baseline and post-fluid challenge (approximately 1 hour)

Secondary Outcomes (7)

• Inferior vena cava diameter and respiratory variation

  pre-fluid challenge baseline and post-fluid challenge (approximately 1 hour)

• subclavian vein diameter and respiratory variation

  pre-fluid challenge baseline and post-fluid challenge (approximately 1 hour)

• pulse pressure variation

  pre-fluid challenge baseline and post-fluid challenge (approximately 1 hour)

• central venous pressure (CVP) and CVP respiratory variation

  pre-fluid challenge baseline and post-fluid challenge (approximately 1 hour)

• pulmonary capillary wedge pressure (PCWP) and respiratory variations of PCWP

  pre-fluid challenge baseline and post-fluid challenge (approximately 1 hour)

Study Arms (1)

Hypotensive patients in shock

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult Intensive Care Unit Patients

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Chicago: lead

Study Sites (1)

The University of Chicago Medical Center

Chicago, Illinois, 60637, United States

Location

MeSH Terms

Conditions

Hypotension; Shock

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Kress P John, MD

  University of Chicago

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 18, 2012
• First Posted: September 7, 2012
• Study Start: June 1, 2010
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: August 17, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)