Hyperaldosteronism, Renal Insufficiency
Conditions
Keywords
primary aldosteronism, surgery therapy, water intake, renal function
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.
Interventions
DIETARY_SUPPLEMENTHydration
the same with arm descriptions
Sponsors
Qifu Li
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Renal decline | Baseline and 3 months | Change in estimated glomerular filtration rate between baseline and 3 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Copeptin | Baseline 3, and 6 months | Change in copeptin among baseline, 3 and 6 months |
| 24-hour urine albumin | Baseline,3 and 6 months | Change in 24-hour urine albumin among baseline, 3 and 6 months |
| Waist circumference | Baseline 3, and 6 months | Change in waist circumference 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 |
| 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 |
Countries
China
Outcome results
None listed