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

This study is currently recruiting participants.

Verified by University of Virginia, August 2008

Sponsors and Collaborators:	University of Virginia National Institutes of Health (NIH)
Information provided by:	University of Virginia
ClinicalTrials.gov Identifier:	NCT00631553

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

MedlinePlus related topics: Ultrasound

Drug Information available for: Sodium chloride Octafluoropropane Lipids

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Diagnostic, Open Label, Active Control, Single Group Assignment, Efficacy Study
Official Title:	Assessment of Changes in Renal Cortical and Medullary Blood Flow by Contrast Ultrasound

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:

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).

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

Responsible Party:	University of Virginia Dept of Medicine ( Kambiz Kalantarinia MD Assitant Professor of Medicine )
Study ID Numbers:	12014
Study First Received:	February 27, 2008
Last Updated:	August 6, 2008
ClinicalTrials.gov Identifier:	NCT00631553
Health Authority:	United States: Food and Drug Administration

ClinicalTrials.gov processed this record on January 15, 2009