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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 because the information has not been verified recently.
Verified August 2008 by University of Virginia.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by:
University of Virginia
ClinicalTrials.gov Identifier:
NCT00631553
First received: February 27, 2008
Last updated: August 6, 2008
Last verified: August 2008
History of Changes
  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: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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:

Drug Information available for: Perflutren
U.S. FDA Resources

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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: February 27, 2008
Last Updated: August 6, 2008
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on May 22, 2013