Ignite Creation Date:
2025-12-25 @ 12:31 AM
Ignite Modification Date:
2025-12-25 @ 10:38 PM
Study NCT ID:
NCT05550467
Status:
COMPLETED
Last Update Posted:
2022-09-22
First Post:
2022-09-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
24-hour Urinary Electrolyte Excretion in Chronic Kidney Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}], 'ancestors': [{'id': 'D051437', 'term': 'Renal Insufficiency'}, {'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'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-09', 'completionDateStruct': {'date': '2022-07-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-09-19', 'studyFirstSubmitDate': '2022-09-19', 'studyFirstSubmitQcDate': '2022-09-19', 'lastUpdatePostDateStruct': {'date': '2022-09-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-09-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-07-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Kidney disease progression', 'timeFrame': '2014.1.1-2022.7.31', 'description': 'eGFR decline \\> 50%; dialysis; kidney transplant'}, {'measure': 'Death', 'timeFrame': '2014.1.1-2022.7.31', 'description': 'All cause death'}], 'secondaryOutcomes': [{'measure': 'Cardiovascular disease', 'timeFrame': '2014.1.1-2022.7.31', 'description': 'myocardial infarction, angina pectoris, stable heart failure, peripheral artery disease , revascularization, cerebrovascular events'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Chronic Kidney Diseases', 'Electrolyte Imbalance']}, 'descriptionModule': {'briefSummary': 'Association between excretion pattern and development trajectory of urinary electrolytes (urine sodium, urine potassium, urine chlorine, urine magnesium, urine calcium, urine phosphorus, urine creatinine, urea, uric acid, urine glucose, urine protein, urine retinol) and adverse prognosis in patients with chronic kidney disease'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Age ≥ 18 years, chronic kidney disease patients without kidney replacement therapy who had 24-h urine eletrocyte tests.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Our study is a retrospective cohort study. The study included patients with adult（Age≥18years）CKD who were hospitalized in the Department of Nephrology, First Medical Center of Chinese PLA General Hospital from January 2014 to July 2022. Patients with CKD who had one or more 24-hour urinary electrolyte excretion tests at intervals of more than three months were included in the subgroup analysis.\n\nExclusion Criteria:\n\n* Patients with hemodialysis therapy and urine volume less than 500ml were excluded.'}, 'identificationModule': {'nctId': 'NCT05550467', 'briefTitle': '24-hour Urinary Electrolyte Excretion in Chronic Kidney Disease', 'organization': {'class': 'OTHER', 'fullName': 'Chinese PLA General Hospital'}, 'officialTitle': '24-hour Urinary Electrolyte Excretion and Renal Prognosis in Chronic Kidney Disease：a Retrospective Cohort Study', 'orgStudyIdInfo': {'id': '2015BAI12B06-03'}}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chinese PLA General Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr.', 'investigatorFullName': 'LIANG Shuang', 'investigatorAffiliation': 'Chinese PLA General Hospital'}}}}