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

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

Study Overview

• Status: Withdrawn
• Conditions: Renal Insufficiency; Hyperaldosteronism
• Intervention / Treatment: Dietary supplement: Hydration

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.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Chongqing
    • Chongqing, Chongqing, China, 400016
      • The First Affilated Hospital of Chongqing Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control
Experimental: 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	Dietary supplement: Hydration; the same with arm descriptions

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Renal decline	Change in estimated glomerular filtration rate between baseline and 3 months	Baseline and 3 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Qifu Li

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Anticipated): December 1, 2019
• Primary Completion (Anticipated): May 1, 2020
• Study Completion (Anticipated): December 1, 2020

Study Registration Dates

• First Submitted: November 1, 2019
• First Submitted That Met QC Criteria: November 1, 2019
• First Posted (Actual): November 5, 2019

Study Record Updates

• Last Update Posted (Actual): July 15, 2020
• Last Update Submitted That Met QC Criteria: July 13, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: renal function; primary aldosteronism; water intake; surgery therapy
• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Endocrine System Diseases; Adrenocortical Hyperfunction; Adrenal Gland Diseases; Renal Insufficiency; Hyperaldosteronism
• Other Study ID Numbers: WIT-PAP Study 2019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No