HealthyPhase 1/2NCT02672722
Assessment of the Changes in Cortical and Medullary Renal Blood Flow During Exercise in Healthy Subjects Using Contrast Enhanced Ultrasound
A Phase 1/2 study testing Definity, Exercise and Kidney Ultrasound in people with Healthy and Physiology, run by University of Virginia at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy, Physiology
- What is being tested?
- Definity, Exercise and Kidney Ultrasound
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2016to Oct 2017
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy Adult - 18 to 50 years old
- All ethnicity and genders
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
University of Virginia
Charlottesville, Virginia, 22908
Sharon F Johnson, BA, 434-982-3198, sfj8n@virginia.edu
Kambiz Kalantarinia, MD, 4349823198, KK6C@hscmail.mcc.virginia.edu
About this study
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.
Read the detailed description
This study requires a screening day and two visits on separate days to the Clinical Research Unit (CRU). Three visits total.
Screening Visit:
- The subjects will undergo detailed history and physical examination.
- The inclusion and exclusion criteria will be reviewed.
- The details of the study procedures, potential risks and benefits will be reviewed with each subject and all potential questions will be answered.
- Subjects' understating of all details of the study components will be ascertained and they will be asked to sign the informed consent form.
- A copy of the signed informed consent will be placed in study file and another copy will be provided to each subject.
- The study visit day will be scheduled within 2 weeks of the screening day.
- All subjects will be asked to arrive on their first study day after an overnight fast. They will be instructed to avoid caffeine and exercise for 24 hours.
Study Day #1 The subjects will arrive in the CRU in the morning. Subjects' understanding of all study related procedures will be assessed and all remaining questions will be answered. The following sequence of procedures will be followed for all enrolled subjects.
- Physical exam including vital signs (Blood Pressure, Heart Rate, Weight, Height, Respiration Rate, Temperature)
- Urine pregnancy test for women of child bearing age. If positive, subjects will be excluded. Determination of peak oxygen consumption
- Subjects will complete a continuous VO2 peak bicycle ergometer protocol.
- Each subject will start peddling on a stationary bike
- The initial power output (PO) will be set at 20 watts
- The power output will be increased by 15 watts every 2-minutes until volitional exhaustion.
- Metabolic data will be collected during the protocol using standard open-circuit spirometric techniques (Viasys Vmax Encore, Yorba Linda, CA)
- Heart rate was assessed electrocardiographically.
- VO2 peak will be chosen as the highest VO2 attained during the exercise protocol
On Day 2 of testing
- Check Vitals (BP, HR, Wt., RR, Temp.)
- Insert peripheral IV line Baseline renal blood flow measurement using contrast enhanced ultrasonography
- The Definity vial will be placed at room temperature before being used. It will be activated after shaking the vial using Vialmax® for 45 seconds. It will be used immediately after activation.
- 0.4 ml of Definity will be mixed in 10 ml of preservative free saline.
- Infusion of Definity into a peripheral vein will be started at 2 ml/min and titrated for optimal image quality using a minipump (not to exceed 10 ml/min at any time).
- Baseline contrast ultrasound imaging of right kidney will be performed with low mechanical index (MI) of 0.2.
- 4 - 5 ultrasound impulses with high MI of 1.0 and duration of 1 second will be used to destruct the microbubbles in the kidney tissue
- Ultrasound imaging of the kidney with low MI (0.2) will continue immediately after each impulse for several seconds.
- Infusion of Definity will stop at this point.
- Vital signs will be monitored every 15 minutes and continuous pulse oximetry will be performed during Definity administration.
- Vital signs and pulse oximetry will be monitored every 15 minutes until 30 minutes after discontinuation of Definity.
- A urine dipstick will be performed by the study team 30 minutes after completion of Definity infusion if a sample is available. Constant load Exercise protocol
- Subjects will complete 30 minutes of continuous cycling at the power output associated with 85% of VO2peak from the continuous bicycle ergometer protocol. Metabolic data will be collected as described above.
- Once metabolic parameter are reached, exercise will be stopped and subject will be asked to lie down on the bed Renal Blood flow measurement following exercise using contrast enhanced ultrasonography
- Immediately after completion of exercise protocol, steps 5 - 12 under day 2 procedures will be repeated.
- The study procedures will end at this point.
- Conditions
- Healthy, Physiology
- Being tested
- Definity, Exercise, Kidney Ultrasound
- 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.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DefinityDrug
Also called ultrasound contrast agent or microbubbles
During kidney ultrasound, Definity microbubbles will be injected into the vein to see how blood flows through the kidneys
ExerciseOther
Also called stationary Bike
Kidney UltrasoundOther
Also called Renal Ultrasound examination
This done before and after exercise with the help of Definity to see changes in kidney blood flow
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Definity; Other: Exercise; Other: Kidney Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Before and immediately after exercise
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2016 (estimated)
- Study startJan 2016
- Primary completionAug 2017 (estimated)
- Study completionOct 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by University of VirginiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 19 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kambiz Kalantarinia, University of Virginia
- Investigators
- Kambiz Kalantarinia, MD, Principal investigator, University of Virginia, Department of Nephrology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02672722
- Sponsor's protocol ID
- 18220
- Status last verified
- May 2017
- First submitted
- 25 Jan 2016
- Last updated
- 12 May 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Changes in Cortical and Medullary Renal Blood Flow During Exercise in Healthy Subjects Using Contrast Enhanced Ultrasound
- ClinicalTrials.gov ID
- NCT02672722
- Acronym / sponsor ID
- 18220
- Conditions
- Healthy, Physiology
- 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.
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 19 participants (estimated)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Study start
- Jan 2016 (actual)
- Primary completion
- Aug 2017 (estimated)
- Study completion
- Oct 2017 (estimated)
- First posted
- 3 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study requires a screening day and two visits on separate days to the Clinical Research Unit (CRU). Three visits total.
Screening Visit:
- The subjects will undergo detailed history and physical examination.
- The inclusion and exclusion criteria will be reviewed.
- The details of the study procedures, potential risks and benefits will be reviewed with each subject and all potential questions will be answered.
- Subjects' understating of all details of the study components will be ascertained and they will be asked to sign the informed consent form.
- A copy of the signed informed consent will be placed in study file and another copy will be provided to each subject.
- The study visit day will be scheduled within 2 weeks of the screening day.
- All subjects will be asked to arrive on their first study day after an overnight fast. They will be instructed to avoid caffeine and exercise for 24 hours.
Study Day #1 The subjects will arrive in the CRU in the morning. Subjects' understanding of all study related procedures will be assessed and all remaining questions will be answered. The following sequence of procedures will be followed for all enrolled subjects.
- Physical exam including vital signs (Blood Pressure, Heart Rate, Weight, Height, Respiration Rate, Temperature)
- Urine pregnancy test for women of child bearing age. If positive, subjects will be excluded. Determination of peak oxygen consumption
- Subjects will complete a continuous VO2 peak bicycle ergometer protocol.
- Each subject will start peddling on a stationary bike
- The initial power output (PO) will be set at 20 watts
- The power output will be increased by 15 watts every 2-minutes until volitional exhaustion.
- Metabolic data will be collected during the protocol using standard open-circuit spirometric techniques (Viasys Vmax Encore, Yorba Linda, CA)
- Heart rate was assessed electrocardiographically.
- VO2 peak will be chosen as the highest VO2 attained during the exercise protocol
On Day 2 of testing
- Check Vitals (BP, HR, Wt., RR, Temp.)
- Insert peripheral IV line Baseline renal blood flow measurement using contrast enhanced ultrasonography
- The Definity vial will be placed at room temperature before being used. It will be activated after shaking the vial using Vialmax® for 45 seconds. It will be used immediately after activation.
- 0.4 ml of Definity will be mixed in 10 ml of preservative free saline.
- Infusion of Definity into a peripheral vein will be started at 2 ml/min and titrated for optimal image quality using a minipump (not to exceed 10 ml/min at any time).
- Baseline contrast ultrasound imaging of right kidney will be performed with low mechanical index (MI) of 0.2.
- 4 - 5 ultrasound impulses with high MI of 1.0 and duration of 1 second will be used to destruct the microbubbles in the kidney tissue
- Ultrasound imaging of the kidney with low MI (0.2) will continue immediately after each impulse for several seconds.
- Infusion of Definity will stop at this point.
- Vital signs will be monitored every 15 minutes and continuous pulse oximetry will be performed during Definity administration.
- Vital signs and pulse oximetry will be monitored every 15 minutes until 30 minutes after discontinuation of Definity.
- A urine dipstick will be performed by the study team 30 minutes after completion of Definity infusion if a sample is available. Constant load Exercise protocol
- Subjects will complete 30 minutes of continuous cycling at the power output associated with 85% of VO2peak from the continuous bicycle ergometer protocol. Metabolic data will be collected as described above.
- Once metabolic parameter are reached, exercise will be stopped and subject will be asked to lie down on the bed Renal Blood flow measurement following exercise using contrast enhanced ultrasonography
- Immediately after completion of exercise protocol, steps 5 - 12 under day 2 procedures will be repeated.
- The study procedures will end at this point.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy Test Subjects | Experimental | Drug: Definity, Other: Exercise, Other: Kidney UltrasoundWe 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. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy Adult - 18 to 50 years old
- All ethnicity and genders
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DefinityAlso: ultrasound contrast agent or microbubblesDuring kidney ultrasound, Definity microbubbles will be injected into the vein to see how blood flows through the kidneys | Drug | Healthy Test Subjects |
| ExerciseAlso: stationary Bike | Other | Healthy Test Subjects |
| Kidney UltrasoundAlso: Renal Ultrasound examinationThis done before and after exercise with the help of Definity to see changes in kidney blood flow | Other | Healthy Test Subjects |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kambiz Kalantarinia, MD principal investigator
University of Virginia, Department of Nephrology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Definity, Exercise and Kidney Ultrasound in people with Healthy and Physiology, run by University of Virginia at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sharon F Johnson, BA (4349823198, sfj8n@virginia.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in renal blood flow in exercise as assessed by CEUS (time frame: Before and immediately after exercise). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2017.