Recruiting
Phase 1
Phase 2

Observational Study

Sponsor:

University of Virginia

Code:

NCT02672722

Conditions

Healthy

Physiology

Eligibility Criteria

Sex: All

Age: 18 - 50

Healthy Volunteers: Accepted

Interventions

Definity

Exercise

Kidney Ultrasound

Study Details

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.

Conditions

Healthy

Physiology

Study ID

NCT02672722

Start date

Jan, 2016

Status verified date

May, 2017

Completion date

Oct, 2017

Anticipated

Primary completion date

Aug, 2017

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 50

Healthy Volunteers: Accepted

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Study Design

Enrollment

19 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: Healthy Test Subjects

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.

Interventions

Definity

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

Exercise

Kidney Ultrasound

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

Primary outcome measure

  • Change in renal blood flow in exercise as assessed by CEUS [ Time Frame: Before and immediately after exercise ]

Central Contacts and Locations

Central contacts

Sharon F Johnson, BA

4349823198sfj8n@virginia.edu

Kambiz Kalantarinia, MD

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

Locations

University of Virginia

Recruiting

Charlottesville, Virginia, United States, 22908

Contacts

Sharon F Johnson, BA

434-982-3198sfj8n@virginia.edu

Kambiz Kalantarinia, MD

4349823198KK6C@hscmail.mcc.virginia.edu

Principal Investigator:

Kambiz Kalantarinia, MD

More Information

Sponsor

University of Virginia

Last update posted

May 12, 2017

Last verified

May, 2017

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.

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Virginia on 2017-05-12.