Effect of Water Intake and Water Restriction on Total Kidney Volume in Autosomal Dominant Polycystic Kidney: The HYDRA Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Rigshospitalet, Denmark
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Change in total kidney volume
Study Overview
Brief Summary
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.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •CKD stage 1-3
Exclusion Criteria
- •Patients treated with diuretics
- •Pregnancy
- •Change in antihypertensive treatment < 1 month
- •Any condition contraindicating MR scan
Arms & Interventions
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.
Intervention: water (Other)
Outcomes
Primary Outcomes
Change in total kidney volume
Time Frame: Baseline and 3 hours
Secondary Outcomes
- 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)
Investigators
Signe Vinsand Naver
MD
Rigshospitalet, Denmark