Effect of Water Intake and Water Restriction on Total Kidney Volume in Autosomal Dominant Polycystic Kidney: The HYDRA Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Change in total kidney volume
研究概览
简要总结
The objective of this study is to measure the influence of both short term water restriction and high water intake on total kidney volume, measured by Magnetic Resonance Imaging (MRI) scan in Autosomal Dominant Polycystic Kidney Disease (ADPKD) patients.
详细描述
Patients will be randomized to either water restriction for 3 hours or high water intake (20 ml/kg) for 1 hour. Before intervention and after intervention patients will have an MRI scan of the kidneys to measure the total kidney volume (TKV) (differentiated in cortex, medulla and cyst volume). The objective is to identify whether water restriction or high water load will change the TKV. Secondly investigators will analyze different biomarkers (aldosterone, renin, vasopressin/copeptin, urine- and blood-osmolarity) before and after the intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •CKD stage 1-3
排除标准
- •Patients treated with diuretics
- •Pregnancy
- •Change in antihypertensive treatment < 1 month
- •Any condition contraindicating MR scan
研究组 & 干预措施
water restriction
20 patients will be subjected to 3 hours of water restriction following MR scan of the kidneys.
high water intake
20 patients will be subjected to 1 hour of high water intake (20 ml/kg) following MR scan of the kidneys.
干预措施: water (Other)
结局指标
主要结局
Change in total kidney volume
时间窗: Baseline and 3 hours
次要结局
- Change in plasma renin(Baseline and 3 hours)
- Change in plasma aldosterone(Baseline and 3 hours)
- Change in total cyst volume(Baseline and 3 hours)
- Change in plasma copeptin(Baseline and 3 hours)
研究者
Signe Vinsand Naver
MD
Rigshospitalet, Denmark