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Assessment of Changes in Renal Cortical and Medullary Blood Flow by Contrast Ultrasound

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified August 2008 by University of Virginia.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00631553
First Posted: March 7, 2008
Last Update Posted: August 7, 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:
National Institutes of Health (NIH)
Information provided by:
University of Virginia
  Purpose
The purpose of this study is to determine if contrast enhanced ultrasound (CEU) using microbubbles, is useful in assessing changes in kidney blood flow.

Condition Intervention
Kidney Drug: perflutren lipid microspheres

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Assessment of Changes in Renal Cortical and Medullary Blood Flow by Contrast Ultrasound

Resource links provided by NLM:


Further study details as provided by University of Virginia:

Estimated Enrollment: 20
Study Start Date: June 2006
Estimated Study Completion Date: December 2009
Intervention Details:
    Drug: perflutren lipid microspheres
    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).
    Other Name: Definity
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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)
  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): NCT00631553


Contacts
Contact: Kambiz Kalantarinia, MD 434 924 5125 kk6c@virginia.edu
Contact: Lori Ratliff, RN ANP 434 924 5820 ext 4-1572 lbr@virginia.edu

Locations
United States, Virginia
University of Virginia Health System Recruiting
Charlottesville, Virginia, United States, 22908
Contact: Kalantarinia       kk6cQ@virginia.edu   
Contact: Ratliff       lbr@virgina.edu   
Principal Investigator: Kambiz Kalantarinia, MD         
Sponsors and Collaborators
University of Virginia
National Institutes of Health (NIH)
Investigators
Principal Investigator: Kambiz Kalantarinia, MD University of Virginia
  More Information

Responsible Party: Kambiz Kalantarinia MD Assitant Professor of Medicine, University of Virginia Dept of Medicine
ClinicalTrials.gov Identifier: NCT00631553     History of Changes
Other Study ID Numbers: 12014
First Submitted: February 27, 2008
First Posted: March 7, 2008
Last Update Posted: August 7, 2008
Last Verified: August 2008