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Assessment of the Changes in Cortical and Medullary Renal Blood Flow During Exercise in Healthy Subjects Using Contrast Enhanced Ultrasound

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02672722
Recruitment Status : Unknown
Verified May 2017 by Kambiz Kalantarinia, University of Virginia.
Recruitment status was:  Recruiting
First Posted : February 3, 2016
Last Update Posted : May 12, 2017
Sponsor:
Information provided by (Responsible Party):
Kambiz Kalantarinia, University of Virginia

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.

Condition or disease Intervention/treatment Phase
Healthy Physiology Drug: Definity Other: Exercise Other: Kidney Ultrasound Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 19 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Assessment of the Changes in Cortical and Medullary Renal Blood Flow During Exercise in Healthy Subjects Using Contrast Enhanced Ultrasound
Actual Study Start Date : January 2016
Estimated Primary Completion Date : August 2017
Estimated Study Completion Date : October 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
Drug: Definity
During kidney ultrasound, Definity microbubbles will be injected into the vein to see how blood flows through the kidneys
Other Name: ultrasound contrast agent or microbubbles

Other: Exercise
Other Name: stationary Bike

Other: Kidney Ultrasound
This done before and after exercise with the help of Definity to see changes in kidney blood flow
Other Name: Renal Ultrasound examination




Primary Outcome Measures :
  1. Change in renal blood flow in exercise as assessed by CEUS [ Time Frame: Before and immediately after exercise ]
    Total, cortical and medullary kidney blood flow will be measured using contrast-enhanced ultrasonography



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02672722


Contacts
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Contact: Sharon F Johnson, BA 4349823198 sfj8n@virginia.edu
Contact: Kambiz Kalantarinia, MD 434982-3198 KK6C@hscmail.mcc.virginia.edu

Locations
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United States, Virginia
University of Virginia Recruiting
Charlottesville, Virginia, United States, 22908
Contact: Sharon F Johnson, BA    434-982-3198    sfj8n@virginia.edu   
Contact: Kambiz Kalantarinia, MD    4349823198    KK6C@hscmail.mcc.virginia.edu   
Principal Investigator: Kambiz Kalantarinia, MD         
Sponsors and Collaborators
University of Virginia
Investigators
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Principal Investigator: Kambiz Kalantarinia, MD University of Virginia, Department of Nephrology
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Responsible Party: Kambiz Kalantarinia, MD, University of Virginia
ClinicalTrials.gov Identifier: NCT02672722    
Other Study ID Numbers: 18220
First Posted: February 3, 2016    Key Record Dates
Last Update Posted: May 12, 2017
Last Verified: May 2017
Keywords provided by Kambiz Kalantarinia, University of Virginia:
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.