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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2019-12-01

Study Completion Date

2020-12-01

Brief Summary

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

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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.

Conditions

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Hyperaldosteronism Renal Insufficiency

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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

Group Type EXPERIMENTAL

Hydration

Intervention Type DIETARY_SUPPLEMENT

the same with arm descriptions

Control

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Hydration

the same with arm descriptions

Intervention Type DIETARY_SUPPLEMENT

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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No