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

Qifu Li

Status: Withdrawn

Conditions: Renal Insufficiency; Hyperaldosteronism

Treatments: Dietary Supplement: Hydration

Study type: Interventional

Funder types: Other

Identifiers

NCT04150666

WIT-PAP Study 2019

Details and patient eligibility

About

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

Full 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.

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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0 participants in 2 patient groups

Hydration

Experimental group

Description:

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

Treatment:

Dietary Supplement: Hydration

Control

No Intervention group