The Water Intake Trail and Primary Aldosteronism Postoperation(WIT-PAP)
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Renal decline
研究概览
简要总结
To investigate whether increasing water intake has renal protective effect on PA patients after surgical treatment.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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)
结局指标
主要结局
Renal decline
时间窗: Baseline and 3 months
Change in estimated glomerular filtration rate between baseline and 3 months
次要结局
- 24-hour urine albumin(Baseline,3 and 6 months)
- Copeptin(Baseline 3, and 6 months)
- Rapid renal decline(Baseline 3, and 6 months)
- Measured creatinine clearance(Baseline 3, and 6 months)
- Waist circumference(Baseline 3, and 6 months)
- Renal events(Baseline and 12 months)
- Blood pressure(Baseline 3, and 6 months)
- Body mass index(Baseline 3, and 6 months)
研究者
Qifu Li
Primary Investigator
Chongqing Medical University