Assessment of the Changes in Cortical and Medullary Renal Blood Flow During Exercise in Healthy Subjects Using Contrast Enhanced Ultrasound
试验速览
- 阶段
- 1 期
- 入组人数
- 19
- 试验地点
- 1
- 主要终点
- Change in renal blood flow in exercise as assessed by CEUS
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy Adult - 18 to 50 years old
- •All ethnicity and genders
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Definity (Drug)
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.
干预措施: Exercise (Other)
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.
干预措施: Kidney Ultrasound (Other)
结局指标
主要结局
Change in renal blood flow in exercise as assessed by CEUS
时间窗: Before and immediately after exercise
Total, cortical and medullary kidney blood flow will be measured using contrast-enhanced ultrasonography
次要结局
未报告次要终点
研究者
Kambiz Kalantarinia
MD
University of Virginia