Clinical trial NCT04150666: The Water Intake Trail and Primary Aldosteronism Postoperation(WIT-PAP)
Official title: The Water Intake Trail and Primary Aldosteronism Postoperation(WIT-PAP)
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Hyperaldosteronism
Renal Insufficiency
Keywords: primary aldosteronism
surgery therapy
water intake
renal function
Lead sponsor: Chongqing Medical University
Sponsor class: OTHER
First posted: 2019-11-05
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Renal decline
timeFrame: Baseline and 3 months
Secondary outcomes:
measure: 24-hour urine albumin
timeFrame: Baseline,3 and 6 months
measure: Rapid renal decline
timeFrame: Baseline 3, and 6 months
measure: Measured creatinine clearance
timeFrame: Baseline 3, and 6 months
measure: Copeptin
timeFrame: Baseline 3, and 6 months
measure: Blood pressure
timeFrame: Baseline 3, and 6 months
measure: Waist circumference
timeFrame: Baseline 3, and 6 months
measure: Body mass index
timeFrame: Baseline 3, and 6 months
measure: Renal events
timeFrame: Baseline and 12 months
Other outcomes:
Locations:
city: Chongqing
country: China
facility: The First Affilated Hospital of Chongqing Medical University
state: Chongqing
Study officials:
References:
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 adrenalectomy. Int J Urol. 2013 Jul;20(7):693-4. doi: 10.1111/iju.12052. Epub 2012 Dec 11. No abstract available.
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 Treatment to Subsequent Adrenalectomy. Intern Med. 2018 Sep 1;57(17):2459-2466. doi: 10.2169/internalmedicine.0438-17. Epub 2018 Apr 27.
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.
citation: 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 CKD WIT Randomized Clinical Trial. JAMA. 2018 May 8;319(18):1870-1879. doi: 10.1001/jama.2018.4930.