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A Simple Clinical Tool to Help Assess Patient Volume (Fluid) Status

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00599794
First Posted: January 24, 2008
Last Update Posted: January 24, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Abbott Northwestern Hospital
Information provided by:
Mayo Clinic
  Purpose
Patients may have actual or relative intravascular volume depletion in a number of different disease states, particularly with sepsis syndrome. However, it is clinically difficult to determine volume status without invasive monitoring, which may cause unintended complications. Our hypothesis is that we can accurately estimate central venous pressure, which is a surrogate marker of volume status, with a noninvasive portable ultrasound device.

Condition
Sepsis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Simple Clinical Tool to Help Assess Patient Volume (Fluid) Status

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Enrollment: 84
Study Start Date: January 2006
Study Completion Date: January 2008
Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
Healty volunteers who are euvolemic.
2
Critically ill patients who will be having a central venous catheter with a monitor to measure central venous pressure placed as part of their planned care independent of this study.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Healthy volunteers, then critically ill patients already in the intensive care unit who are felt to have intravascular volume depletion.
Criteria

Inclusion Criteria:

  • Age 18 or older.
  • Healthy, euvolemic volunteers and critically ill patients who are already in an intensive care unit and who will have a central venous catheter placed as part of their planned medical treatment.

Exclusion Criteria:

  • Inability to use ultrasound to measure jugular vein (neck brace or bandage), "code" situation.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00599794


Locations
United States, Minnesota
Abbott Northwestern Hospital
Minneapolis, Minnesota, United States, 55407
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Abbott Northwestern Hospital
Investigators
Principal Investigator: A. S. Keller, MD Mayo Clinic
  More Information

Additional Information:
Responsible Party: A. Scott Keller, Mayo Clinic
ClinicalTrials.gov Identifier: NCT00599794     History of Changes
Other Study ID Numbers: 05-004138
First Submitted: January 11, 2008
First Posted: January 24, 2008
Last Update Posted: January 24, 2008
Last Verified: January 2008

Keywords provided by Mayo Clinic:
Sepsis
Intravascular volume
Ultrasound
Noninvasive measurement

Additional relevant MeSH terms:
Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes