NCT00631553

Brief Summary

The purpose of this study is to determine if contrast enhanced ultrasound (CEU) using microbubbles, is useful in assessing changes in kidney blood flow.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2006

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

June 1, 2006

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

February 27, 2008

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 7, 2008

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

August 7, 2008

Status Verified

August 1, 2008

First QC Date

February 27, 2008

Last Update Submit

August 6, 2008

Conditions

Kidney

Interventions

perflutren lipid microspheresDRUG

1.3 ml in 30 ml of saline, infused into vein at 2ml / min and titrated for optimal image quality (not to exceed 10 ml/ min at any time).

Also known as: Definity

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy adults
  • Males and females
  • Ages 18-65 years old

You may not qualify if:

  • Pregnancy or lactation
  • H/o kidney disease
  • H/o congestive heart failure, ischemic heart disease, severe pulmonary disease or allergy to the drug
  • H/o any cardiovascular disease
  • Abnormal liver function (liver function tests out of specified ranges)
  • Screening urinalysis which indicates infection or inflammation
  • Taking regular medications (except for over-the-counter vitamins or hormonal contraceptives.)
  • Taking supplements, like protein shakes
  • Unwilling or unable to eat chicken (used as protein meal)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Virginia Health System

Charlottesville, Virginia, 22908, United States

RECRUITING

MeSH Terms

Interventions

perflutren

Study Officials

  • Kambiz Kalantarinia, MD

    University of Virginia

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Kambiz Kalantarinia, MD

CONTACT

434 924 5125kk6c@virginia.edu

Lori Ratliff, RN ANP

CONTACT

434 924 5820lbr@virginia.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 27, 2008

First Posted

March 7, 2008

Study Start

June 1, 2006

Study Completion

December 1, 2009

Last Updated

August 7, 2008

Record last verified: 2008-08

Locations

US(1)