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

NCT04150666 | Withdrawn DMC

• 1 other identifier: WIT-PAP Study 2019
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hyperaldosteronism; Renal Insufficiency

Keywords

primary aldosteronism; surgery therapy; water intake; renal function

Outcome Measures

Primary Outcomes (1)

• Renal decline

  Change in estimated glomerular filtration rate between baseline and 3 months

  Baseline and 3 months

Secondary Outcomes (8)

• 24-hour urine albumin

  Baseline,3 and 6 months

• Rapid renal decline

  Baseline 3, and 6 months

• Measured creatinine clearance

  Baseline 3, and 6 months

• Copeptin

  Baseline 3, and 6 months

• Blood pressure

  Baseline 3, and 6 months

Study Arms (2)

Hydration

EXPERIMENTAL

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

Control

NO INTERVENTION

Interventions

Hydration DIETARY_SUPPLEMENT

the same with arm descriptions

Hydration

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Qifu Li: lead

Study Sites (1)

The First Affilated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, 400016, China

Location

Related Publications (4)

• 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.

  PMID: 23231595 RESULT

• 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.

  PMID: 29709927 RESULT

• 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.

  PMID: 29987110 RESULT

• 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.

  PMID: 29801012 RESULT

MeSH Terms

Conditions

Hyperaldosteronism; Renal Insufficiency

Condition Hierarchy (Ancestors)

Adrenocortical Hyperfunction; Adrenal Gland Diseases; Endocrine System Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Primary Investigator

Study Record Dates

• First Submitted: November 1, 2019
• First Posted: November 5, 2019
• Study Start: December 1, 2019
• Primary Completion: May 1, 2020
• Study Completion: December 1, 2020
• Last Updated: July 15, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)