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

NCT ID: NCT00631553

Last Updated: 2008-08-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-06-30

Study Completion Date

2009-12-31

Brief Summary

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

Detailed Description

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Conditions

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Kidney

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Interventions

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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).

Intervention Type DRUG

Other Intervention Names

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Definity

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institutes of Health (NIH)

NIH

Sponsor Role collaborator

University of Virginia

OTHER

Sponsor Role lead

Responsible Party

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University of Virginia Dept of Medicine

Principal Investigators

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Kambiz Kalantarinia, MD

Role: PRINCIPAL_INVESTIGATOR

University of Virginia

Locations

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University of Virginia Health System

Charlottesville, Virginia, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Kambiz Kalantarinia, MD

Role: CONTACT

Phone: 434 924 5125

Email: [email protected]

Lori Ratliff, RN ANP

Role: CONTACT

Phone: 434 924 5820

Email: [email protected]

Facility Contacts

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Kalantarinia

Role: primary

Ratliff

Role: backup

Other Identifiers

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12014

Identifier Type: -

Identifier Source: org_study_id