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

Not Applicable

Withdrawn

• Conditions: Hyperaldosteronism; Renal Insufficiency
• Interventions: Dietary Supplement: Hydration

• Registration Number: NCT04150666
• Lead Sponsor: Qifu Li

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study First Submitted: 2019-11-01
• Study First Submitted QC: 2019-11-01
• Study First Posted: 2019-11-05
• Study Start: 2019-12-01
• Primary Completion: 2020-05-01
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-13
• Last Update Posted: 2020-07-15
• Study Completion: 2020-12-01

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hydration	Hydration	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

Primary Outcome Measures

Name	Time	Method
Renal decline	Baseline and 3 months	Change in estimated glomerular filtration rate between baseline and 3 months

Secondary Outcome Measures

Name	Time	Method
24-hour urine albumin	Baseline,3 and 6 months	Change in 24-hour urine albumin among baseline, 3 and 6 months
Copeptin	Baseline 3, and 6 months	Change in copeptin among baseline, 3 and 6 months
Rapid renal decline	Baseline 3, and 6 months	Proportion with eGFR (estimated glomerular filtration rate) decline \>5% among Baseline 3, and 6 months
Measured creatinine clearance	Baseline 3, and 6 months	Change in measured creatinine clearance among baseline, 3 and 6 months
Waist circumference	Baseline 3, and 6 months	Change in waist circumference among baseline, 3 and 6 months
Renal events	Baseline and 12 months	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
Blood pressure	Baseline 3, and 6 months	Change in blood pressure among baseline, 3 and 6 months
Body mass index	Baseline 3, and 6 months	Change in body mass index among baseline, 3 and 6 months

Trial Locations

Locations (1)

The First Affilated Hospital of Chongqing Medical University; 🇨🇳 Chongqing, Chongqing, China