- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT02672722
Assessment of the Changes in Cortical and Medullary Renal Blood Flow During Exercise in Healthy Subjects Using Contrast Enhanced Ultrasound
Studieöversikt
Status
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Förväntat)
Fas
- Fas 2
- Fas 1
Kontakter och platser
Studiekontakt
- Namn: Sharon F Johnson, BA
- Telefonnummer: 4349823198
- E-post: sfj8n@virginia.edu
Studera Kontakt Backup
- Namn: Kambiz Kalantarinia, MD
- Telefonnummer: 434982-3198
- E-post: KK6C@hscmail.mcc.virginia.edu
Studieorter
-
-
Virginia
-
Charlottesville, Virginia, Förenta staterna, 22908
- Rekrytering
- University of Virginia
-
Kontakt:
- Sharon F Johnson, BA
- Telefonnummer: 434-982-3198
- E-post: sfj8n@virginia.edu
-
Kontakt:
- Kambiz Kalantarinia, MD
- Telefonnummer: 4349823198
- E-post: KK6C@hscmail.mcc.virginia.edu
-
Huvudutredare:
- Kambiz Kalantarinia, MD
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Diagnostisk
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Experimentell: 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.
|
Andra namn:
During kidney ultrasound, Definity microbubbles will be injected into the vein to see how blood flows through the kidneys
Andra namn:
This done before and after exercise with the help of Definity to see changes in kidney blood flow
Andra namn:
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Change in renal blood flow in exercise as assessed by CEUS
Tidsram: Before and immediately after exercise
|
Total, cortical and medullary kidney blood flow will be measured using contrast-enhanced ultrasonography
|
Before and immediately after exercise
|
Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Kambiz Kalantarinia, MD, University of Virginia, Department of Nephrology
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Förväntat)
Avslutad studie (Förväntat)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Andra studie-ID-nummer
- 18220
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