Expired Study
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Charlottesville, Virginia 22908


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.


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)


Study is Available At:


Original ID:

12014


NCT ID:

NCT00631553


Secondary ID:


Study Acronym:


Brief Title:

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


Official Title:

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


Overall Status:

Recruiting


Study Phase:

N/A


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

65 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

University of Virginia


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Endpoint Classification: Efficacy Study, Interven


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

20


Enrollment Type:

Anticipated


Overall Contact Information

Official Name:Kambiz Kalantarinia, MD
Principal Investigator
University of Virginia
Primary Contact:Kambiz Kalantarinia, MD
434 924 5125
kk6c@virginia.edu
Backup Contact:Lori Ratliff, RN ANP
434 924 5820 ext. 4-1572
434 924 5820
lbr@virginia.edu

Study Dates

Start Date:June 2006
Completion Date:December 2009
Completion Type:Anticipated
Verification Date:August 2008
Last Changed Date:August 6, 2008
First Received Date:February 27, 2008

Study Outcomes

There are no available Study Outcomes

Study Interventions

Intervention Type:Drug
Name:perflutren lipid microspheres
Description: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

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:University of Virginia
Agency Class:NIH
Agency Type:Collaborator
Agency Name:National Institutes of Health (NIH)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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