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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04150666
Recruitment Status : Withdrawn (No subjects are willing to participating.)
First Posted : November 5, 2019
Last Update Posted : July 15, 2020
Sponsor:
Information provided by (Responsible Party):
Qifu Li, Chongqing Medical University

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

Condition or disease Intervention/treatment Phase
Hyperaldosteronism Renal Insufficiency Dietary Supplement: Hydration Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Water Intake Trail and Primary Aldosteronism Postoperation(WIT-PAP)
Estimated Study Start Date : December 1, 2019
Estimated Primary Completion Date : May 1, 2020
Estimated Study Completion Date : December 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Drinking Water

Arm Intervention/treatment
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

No Intervention: Control



Primary Outcome Measures :
  1. Renal decline [ Time Frame: Baseline and 3 months ]
    Change in estimated glomerular filtration rate between baseline and 3 months


Secondary Outcome Measures :
  1. 24-hour urine albumin [ Time Frame: Baseline,3 and 6 months ]
    Change in 24-hour urine albumin among baseline, 3 and 6 months

  2. Rapid renal decline [ Time Frame: Baseline 3, and 6 months ]
    Proportion with eGFR (estimated glomerular filtration rate) decline >5% among Baseline 3, and 6 months

  3. Measured creatinine clearance [ Time Frame: Baseline 3, and 6 months ]
    Change in measured creatinine clearance among baseline, 3 and 6 months

  4. Copeptin [ Time Frame: Baseline 3, and 6 months ]
    Change in copeptin among baseline, 3 and 6 months

  5. Blood pressure [ Time Frame: Baseline 3, and 6 months ]
    Change in blood pressure among baseline, 3 and 6 months

  6. Waist circumference [ Time Frame: Baseline 3, and 6 months ]
    Change in waist circumference among baseline, 3 and 6 months

  7. Body mass index [ Time Frame: Baseline 3, and 6 months ]
    Change in body mass index among baseline, 3 and 6 months

  8. Renal events [ Time Frame: Baseline and 12 months ]
    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



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04150666


Locations
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China, Chongqing
The First Affilated Hospital of Chongqing Medical University
Chongqing, Chongqing, China, 400016
Sponsors and Collaborators
Qifu Li
Publications of Results:
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Responsible Party: Qifu Li, Primary Investigator, Chongqing Medical University
ClinicalTrials.gov Identifier: NCT04150666    
Other Study ID Numbers: WIT-PAP Study 2019
First Posted: November 5, 2019    Key Record Dates
Last Update Posted: July 15, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Qifu Li, Chongqing Medical University:
primary aldosteronism
surgery therapy
water intake
renal function
Additional relevant MeSH terms:
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Renal Insufficiency
Hyperaldosteronism
Kidney Diseases
Urologic Diseases
Adrenocortical Hyperfunction
Adrenal Gland Diseases
Endocrine System Diseases