NCT00599794

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
84

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2006

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2006

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2007

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2008

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

January 11, 2008

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 24, 2008

Completed
Last Updated

January 24, 2008

Status Verified

January 1, 2008

Enrollment Period

1.7 years

First QC Date

January 11, 2008

Last Update Submit

January 23, 2008

Conditions

Sepsis

Keywords

SepsisIntravascular volumeUltrasoundNoninvasive measurement

Study Arms (2)

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 Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Healthy volunteers, then critically ill patients already in the intensive care unit who are felt to have intravascular volume depletion.

You may qualify if:

  • 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.

You may not qualify if:

  • Inability to use ultrasound to measure jugular vein (neck brace or bandage), "code" situation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Abbott Northwestern Hospital

Minneapolis, Minnesota, 55407, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Sepsis

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • A. S. Keller, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 11, 2008

First Posted

January 24, 2008

Study Start

January 1, 2006

Primary Completion

October 1, 2007

Study Completion

January 1, 2008

Last Updated

January 24, 2008

Record last verified: 2008-01

Locations

US(2)