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

This study has been completed.
Sponsor:
Collaborator:
Abbott Northwestern Hospital
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00599794
First received: January 11, 2008
Last updated: January 23, 2008
Last verified: January 2008
  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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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: 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:
No publications provided

Responsible Party: A. Scott Keller, Mayo Clinic
ClinicalTrials.gov Identifier: NCT00599794     History of Changes
Other Study ID Numbers: 05-004138
Study First Received: January 11, 2008
Last Updated: January 23, 2008
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on October 16, 2014