Assessment of the Changes in Cortical and Medullary Renal Blood Flow During Exercise in Healthy Subjects Using Contrast Enhanced Ultrasound
調査の概要
詳細な説明
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.
研究の種類
入学 (予想される)
段階
- フェーズ2
- フェーズ 1
連絡先と場所
研究連絡先
- 名前:Sharon F Johnson, BA
- 電話番号:4349823198
- メール:sfj8n@virginia.edu
研究連絡先のバックアップ
- 名前:Kambiz Kalantarinia, MD
- 電話番号:434982-3198
- メール:KK6C@hscmail.mcc.virginia.edu
研究場所
-
-
Virginia
-
Charlottesville、Virginia、アメリカ、22908
- 募集
- University of Virginia
-
コンタクト:
- Sharon F Johnson, BA
- 電話番号:434-982-3198
- メール:sfj8n@virginia.edu
-
コンタクト:
- Kambiz Kalantarinia, MD
- 電話番号:4349823198
- メール:KK6C@hscmail.mcc.virginia.edu
-
主任研究者:
- Kambiz Kalantarinia, MD
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:診断
- 割り当て:なし
- 介入モデル:単一グループの割り当て
- マスキング:なし(オープンラベル)
武器と介入
参加者グループ / アーム |
介入・治療 |
---|---|
実験的: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.
|
他の名前:
During kidney ultrasound, Definity microbubbles will be injected into the vein to see how blood flows through the kidneys
他の名前:
This done before and after exercise with the help of Definity to see changes in kidney blood flow
他の名前:
|
この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
Change in renal blood flow in exercise as assessed by CEUS
時間枠:Before and immediately after exercise
|
Total, cortical and medullary kidney blood flow will be measured using contrast-enhanced ultrasonography
|
Before and immediately after exercise
|
協力者と研究者
スポンサー
捜査官
- 主任研究者:Kambiz Kalantarinia, MD、University of Virginia, Department of Nephrology
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (予想される)
研究の完了 (予想される)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
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