Ignite Creation Date:
2025-12-24 @ 4:02 PM
Ignite Modification Date:
2025-12-24 @ 4:02 PM
Study NCT ID:
NCT04150666
Status:
WITHDRAWN
Last Update Posted:
2020-07-15
First Post:
2019-11-01
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Water Intake Trail and Primary Aldosteronism Postoperation(WIT-PAP)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006929', 'term': 'Hyperaldosteronism'}, {'id': 'D051437', 'term': 'Renal Insufficiency'}], 'ancestors': [{'id': 'D000308', 'term': 'Adrenocortical Hyperfunction'}, {'id': 'D000307', 'term': 'Adrenal Gland Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'No subjects are willing to participating.', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2019-12-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2020-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-07-13', 'studyFirstSubmitDate': '2019-11-01', 'studyFirstSubmitQcDate': '2019-11-01', 'lastUpdatePostDateStruct': {'date': '2020-07-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-11-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-05-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Renal decline', 'timeFrame': 'Baseline and 3 months', 'description': 'Change in estimated glomerular filtration rate between baseline and 3 months'}], 'secondaryOutcomes': [{'measure': '24-hour urine albumin', 'timeFrame': 'Baseline,3 and 6 months', 'description': 'Change in 24-hour urine albumin among baseline, 3 and 6 months'}, {'measure': 'Rapid renal decline', 'timeFrame': 'Baseline 3, and 6 months', 'description': 'Proportion with eGFR (estimated glomerular filtration rate) decline \\>5% among Baseline 3, and 6 months'}, {'measure': 'Measured creatinine clearance', 'timeFrame': 'Baseline 3, and 6 months', 'description': 'Change in measured creatinine clearance among baseline, 3 and 6 months'}, {'measure': 'Copeptin', 'timeFrame': 'Baseline 3, and 6 months', 'description': 'Change in copeptin among baseline, 3 and 6 months'}, {'measure': 'Blood pressure', 'timeFrame': 'Baseline 3, and 6 months', 'description': 'Change in blood pressure among baseline, 3 and 6 months'}, {'measure': 'Waist circumference', 'timeFrame': 'Baseline 3, and 6 months', 'description': 'Change in waist circumference among baseline, 3 and 6 months'}, {'measure': 'Body mass index', 'timeFrame': 'Baseline 3, and 6 months', 'description': 'Change in body mass index among baseline, 3 and 6 months'}, {'measure': 'Renal events', 'timeFrame': 'Baseline and 12 months', 'description': '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'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['primary aldosteronism', 'surgery therapy', 'water intake', 'renal function'], 'conditions': ['Hyperaldosteronism', 'Renal Insufficiency']}, 'referencesModule': {'references': [{'pmid': '23231595', 'type': 'RESULT', '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.'}, {'pmid': '29709927', 'type': 'RESULT', '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.'}, {'pmid': '29987110', 'type': 'RESULT', '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.'}, {'pmid': '29801012', 'type': 'RESULT', '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.'}]}, 'descriptionModule': {'briefSummary': 'To investigate whether increasing water intake has renal protective effect on PA patients after surgical treatment.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18-75 years\n* Able to provide informed consent and willing to complete follow-up visits.\n* Estimated glomerular filtration(eGFR) rate over 60 ml/min/1•73 m²\n* According to the Guideline of Primary Aldosteronism, unilateral PA has been diagnosed and unilateral adrenalectomy has been completed\n* Urine volume can be recorded consciously, and daily drinking water volume is less than 2L/d\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding\n* Diagnosed with other types of chronic kidney diseases, such as IgA nephropathy, lupus nephritis, etc.\n* History of malignant tumor\n* History of kidney stones in past 5 years\n* Kidney transplant within past six months (or on waiting list)\n* Less than two years life expectancy\n* Serum sodium \\<130 mEq/L without suitable explanation or Serum calcium \\>2.6 mmol/L without suitable explanation\n* Currently taking hydrochlorothiazide \\>25 mg/d, indapamide \\>1.25 mg/d, furosemide \\>40 mg, or metolazone \\>2.5 mg/d\n* Poor blood pressure control (systolic pressure\\>180mmHg or diastolic pressure\\> 110mmHg)\n* Alcoholics, drug addicts, and people with mental disorders who cannot cooperate\n* 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)'}, 'identificationModule': {'nctId': 'NCT04150666', 'briefTitle': 'The Water Intake Trail and Primary Aldosteronism Postoperation(WIT-PAP)', 'organization': {'class': 'OTHER', 'fullName': 'Chongqing Medical University'}, 'officialTitle': 'The Water Intake Trail and Primary Aldosteronism Postoperation(WIT-PAP)', 'orgStudyIdInfo': {'id': 'WIT-PAP Study 2019'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Hydration', 'description': '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', 'interventionNames': ['Dietary Supplement: Hydration']}, {'type': 'NO_INTERVENTION', 'label': 'Control'}], 'interventions': [{'name': 'Hydration', 'type': 'DIETARY_SUPPLEMENT', 'description': 'the same with arm descriptions', 'armGroupLabels': ['Hydration']}]}, 'contactsLocationsModule': {'locations': [{'zip': '400016', 'city': 'Chongqing', 'state': 'Chongqing Municipality', 'country': 'China', 'facility': 'The First Affilated Hospital of Chongqing Medical University', 'geoPoint': {'lat': 29.56026, 'lon': 106.55771}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Qifu Li', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Primary Investigator', 'investigatorFullName': 'Qifu Li', 'investigatorAffiliation': 'Chongqing Medical University'}}}}