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

Renal Insufficiency Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04150666
• Other study ID #: WIT-PAP Study 2019
• Status: Withdrawn
• Phase: N/A
• Start date: December 1, 2019
• Est. completion date: December 1, 2020

Study information

• Verified date: July 2020
• Source: Chongqing Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 1, 2020
• Est. primary completion date: May 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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)

Related Conditions & MeSH terms

• Hyperaldosteronism
• Renal Insufficiency

Intervention

Dietary Supplement:
• Hydration
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Locations

Country	Name	City	State
China	The First Affilated Hospital of Chongqing Medical University	Chongqing	Chongqing

Sponsors (1)

Lead Sponsor	Collaborator
Qifu Li

Country where clinical trial is conducted

China, 

References & Publications (4)

Clark WF, Sontrop JM, Huang SH, Gallo K, Moist L, House AA, Cuerden MS, Weir MA, Bagga A, Brimble S, Burke A, Muirhead N, Pandeya S, Garg AX. Effect of Coaching to Increase Water Intake on Kidney Function Decline in Adults With Chronic Kidney Disease: The — View Citation

Hundemer GL, Curhan GC, Yozamp N, Wang M, Vaidya A. Renal Outcomes in Medically and Surgically Treated Primary Aldosteronism. Hypertension. 2018 Sep;72(3):658-666. doi: 10.1161/HYPERTENSIONAHA.118.11568. — View Citation

Nakano Y, Yoshimoto T, Fukuda T, Murakami M, Bouchi R, Minami I, Hashimoto K, Fujii Y, Kihara K, Ogawa Y. Effect of Eplerenone on the Glomerular Filtration Rate (GFR) in Primary Aldosteronism: Sequential Changes in the GFR During Preoperative Eplerenone T — View Citation

Nishikawa T, Omura M, Saito J, Matsuzawa Y, Kino T. Editorial comment from Dr Nishikawa et al. to preoperative masked renal damage in japanese patients with primary aldosteronism: identification of predictors for chronic kidney disease manifested after ad — View Citation

Outcome

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