The Water Intake Trail and Primary Aldosteronism Postoperation(WIT-PAP)

Study Overview
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Brief Summary
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To investigate whether increasing water intake has renal protective effect on PA patients after surgical treatment.

Detailed Description
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This is a single-center randomized controlled trial study to verify the effect of drinking water on renal function after PA surgery treatment and to follow up the clinical outcomes. We will take short-term follow-up on whether increasing water intake can improve eGFR decline in the early stage of PA patients after surgical treatment and further long-term follow-up to investigate whether increasing drinking water has long-term memory effect to slow down renal function deterioration and improve clinical outcomes. This study will be completed in 1 year.

Official Title
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The Water Intake Trail and Primary Aldosteronism Postoperation(WIT-PAP)

Conditions
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Hyperaldosteronism, Renal Insufficiency

Intervention / Treatment
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* Dietary Supplement: Hydration


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18-75 years Able to provide informed consent and willing to complete follow-up visits. Estimated glomerular filtration(eGFR) rate over 60 ml/min/1•73 m² According to the Guideline of Primary Aldosteronism, unilateral PA has been diagnosed and unilateral adrenalectomy has been completed Urine volume can be recorded consciously, and daily drinking water volume is less than 2L/d Exclusion Criteria: Pregnant or breastfeeding Diagnosed with other types of chronic kidney diseases, such as IgA nephropathy, lupus nephritis, etc. History of malignant tumor History of kidney stones in past 5 years Kidney transplant within past six months (or on waiting list) Less than two years life expectancy Serum sodium <130 mEq/L without suitable explanation or Serum calcium >2.6 mmol/L without suitable explanation Currently taking hydrochlorothiazide >25 mg/d, indapamide >1.25 mg/d, furosemide >40 mg, or metolazone >2.5 mg/d Poor blood pressure control (systolic pressure>180mmHg or diastolic pressure> 110mmHg) Alcoholics, drug addicts, and people with mental disorders who cannot cooperate Patient is under fluid restriction (<1.5 L a day) for kidney disease, heart failure, or liver disease, AND meets any of the following criteria: i) end stage of the disease (heart left ventricular ejection fraction <40%, NYHA class 3 or 4, or end stage cirrhosis) , ii) hospitalization secondary to ACS,heart failure, stroke,ascites and/or anasarca ,iii)Severe anemia (Hb<60g/L)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hydration<br>Participants randomized to the hydration-intervention group will be asked to drink 2.0 to 2.5 L of water per day (depending on sex), in addition to usual consumed beverages, for 3 months | Dietary Supplement: Hydration<br>* the same with arm descriptions<br>|
| No Intervention: Control<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Renal decline | Change in estimated glomerular filtration rate between baseline and 3 months | Baseline and 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 24-hour urine albumin | Change in 24-hour urine albumin among baseline, 3 and 6 months | Baseline,3 and 6 months | 
| Rapid renal decline | Proportion with eGFR (estimated glomerular filtration rate) decline >5% among Baseline 3, and 6 months | Baseline 3, and 6 months | 
| Measured creatinine clearance | Change in measured creatinine clearance among baseline, 3 and 6 months | Baseline 3, and 6 months | 
| Copeptin | Change in copeptin among baseline, 3 and 6 months | Baseline 3, and 6 months | 
| Blood pressure | Change in blood pressure among baseline, 3 and 6 months | Baseline 3, and 6 months | 
| Waist circumference | Change in waist circumference among baseline, 3 and 6 months | Baseline 3, and 6 months | 
| Body mass index | Change in body mass index among baseline, 3 and 6 months | Baseline 3, and 6 months | 
| Renal events | Two of the three morning urine UACR&>300 mg/g Cr, or 24-hour urine protein >300 mg/ 24 h, or serum creatinine level doubled and reached at least 200 μmol/l(2.26 mg/dl), or required renal replacement therapy, or died of renal diseases | Baseline and 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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primary aldosteronism, surgery therapy, water intake, renal function