NCT02672722

Brief Summary

Renal parenchymal blood flow can be divided in cortical and medullary blood flow. Changes and factors affecting renal medullary blood flow have not been studied in detail previously as investigators/doctors did not have tools to monitor renal medullary blood flow in vivo. Since Trueta first described renal medullary blood flow, multiple attempts have been made to study renal medullary blood flow using invasive methods. Recently renal medullary blood flow measurement using contrast US has emerged as a promising technique that investigators can use to study renal medullary blood flow in vivo. In this study investigators are aiming to study changes in renal parenchymal (cortical and medullary) blood flow with exercise in healthy subject.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
19

participants targeted

Target at below P25 for phase_1 healthy

Timeline
Completed

Started Jan 2016

Longer than P75 for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

January 25, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 3, 2016

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2017

Completed
Last Updated

May 12, 2017

Status Verified

May 1, 2017

Enrollment Period

1.6 years

First QC Date

January 25, 2016

Last Update Submit

May 10, 2017

Conditions

HealthyPhysiology

Keywords

This term was found doing the MeSH search and is the only thing that fits since we will be working with healthy subjects with no conditions.

Outcome Measures

Primary Outcomes (1)

  • Change in renal blood flow in exercise as assessed by CEUS

    Total, cortical and medullary kidney blood flow will be measured using contrast-enhanced ultrasonography

    Before and immediately after exercise

Study Arms (1)

Healthy Test Subjects

EXPERIMENTAL

We will be using the drug Definity that is an approved medication for cardiac contrast enhanced ultrasound to measure the changes in kidney blood flow with exercise in healthy subjects.

Drug: DefinityOther: ExerciseOther: Kidney Ultrasound

Interventions

DefinityDRUG

During kidney ultrasound, Definity microbubbles will be injected into the vein to see how blood flows through the kidneys

Also known as: ultrasound contrast agent or microbubbles
Healthy Test Subjects
ExerciseOTHER
Also known as: stationary Bike
Healthy Test Subjects
Kidney UltrasoundOTHER

This done before and after exercise with the help of Definity to see changes in kidney blood flow

Also known as: Renal Ultrasound examination
Healthy Test Subjects

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy Adult - 18 to 50 years old
  • All ethnicity and genders

You may not qualify if:

  • Pregnancy or lactation
  • Active infection
  • Hypertension
  • Chronic Medication Use except Multi Vitamin Use and Birth Control Medications
  • Known history of a right to left intra-cardiac shunt
  • Known history of pulmonary hypertension, including porto-pulmonary hypertension
  • History of allergies to Definity®
  • History of Liver or Kidney Transplant
  • Patient on hemodialysis
  • Has received iodinated contrast within 72 hours of admission to study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Virginia

Charlottesville, Virginia, 22908, United States

RECRUITING

MeSH Terms

Interventions

perflutrenMicrobubblesExercise

Intervention Hierarchy (Ancestors)

Equipment and SuppliesMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Kambiz Kalantarinia, MD

    University of Virginia, Department of Nephrology

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sharon F Johnson, BA

CONTACT

4349823198sfj8n@virginia.edu

Kambiz Kalantarinia, MD

CONTACT

434982-3198KK6C@hscmail.mcc.virginia.edu

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

January 25, 2016

First Posted

February 3, 2016

Study Start

January 1, 2016

Primary Completion

August 1, 2017

Study Completion

October 1, 2017

Last Updated

May 12, 2017

Record last verified: 2017-05

Locations

US(1)