Assessment of Changes in Renal Cortical and Medullary Blo... | NCT00631553

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

NCT00631553

Sponsor

University of Virginia

Status

Unknown status

Last Update Posted

Aug 7, 2008Estimated

Enrollment

20Estimated

Phase

Not Applicable

Conditions

Kidney

Interventions

perflutren lipid microspheres

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2008

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2006

Primary Completion Date

Not provided

Completion Date

Dec 2009Estimated

First Submitted Date

Feb 27, 2008

First Submission Date that Met QC Criteria

Mar 6, 2008

First Posted Date

Mar 7, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 6, 2008

Last Update Posted Date

Aug 7, 2008Estimated

Name	Class
National Institutes of Health (NIH)	NIH

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
perflutren lipid microspheres	Drug	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).		Definity

Eligibility Module

Eligibility 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)

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Kambiz Kalantarinia, MD	Contact	434 924 5125		kk6c@virginia.edu
Lori Ratliff, RN ANP	Contact	434 924 5820	4-1572	lbr@virginia.edu

Overall Officials

Name	Affiliation	Role
Kambiz Kalantarinia, MD	University of Virginia	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Virginia Health System	Recruiting	Charlottesville	Virginia	22908	United States

Type	Date	Date Unknown
Release	Mar 19, 2009
Reset	May 1, 2009
Release	Apr 25, 2011
Unrelease		Yes

Submission Tracking

Estimated Results First Submitted Date

Mar 19, 2009

First MCP Posted Date

Not provided

Submission Infos

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Mar 19, 2009			May 1, 2009
Apr 25, 2011

Intervention Browse Module

MeSH Terms

ID	Term
C042852	perflutren

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided