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Clinical Trial Details

Trial ID: L0282
Source ID: NCT04192110
Associated Drug: Diuretic Initiation Or Augmentation
Title: Association of Diuretics With Change in Extracellular Volume, Natriuretic Peptides, Symptoms, and Cardiovascular Outcomes in CKD
Acronym: DOCK
Status: WITHDRAWN
Study Results: NO
Results:
Conditions: Chronic Kidney Disease
Interventions: DRUG: Diuretic initiation or augmentation
Outcome Measures: Primary: NT-pro-BNP, Change from baseline to 4 weeks in NT-pro-BNP, 4 weeks|Total peripheral resistance index, The change from baseline to 4 weeks in total peripheral resistance index will be measured using Non-Invasive Cardiac Output Monitoring (Cheetah), 4 weeks | Secondary: BNP, Change from baseline to 4 weeks in BNP, 4 weeks|Fatigue, The change in fatigue from baseline to 4 weeks, measured by the Functional Assessment of Chronic Illness Therapy - Fatigue, a validated measure of patient-reported fatigue, 4 weeks|Depression, The change in depressive symptoms from baseline to 4 weeks, measured by the Quick Inventory of Depressive Symptomatology, a validated measure of patient-reported depression, 4 weeks|Quality of Life - Kidney Disease Quality of Life (KDQOL), The change in quality of life from baseline to 4 weeks, measured by the KDQOL, a validated measure of patient-reported quality of life, 4 weeks|Hospitalizations, Hospitalizations as quantified by review of the medical record and telephone contact with the participant, 6 months|Systolic blood pressure, The change in systolic blood pressure from baseline to 4 weeks, 4 weeks|Diastolic blood pressure, The change in diastolic blood pressure from baseline to 4 weeks, 4 weeks|Mean arterial blood pressure, The change in mean arterial blood pressure from baseline to 4 weeks, 4 weeks|Pulse pressure, The change in pulse pressure from baseline to 4 weeks, 4 weeks|Cardiac index, The change from baseline to 4 weeks in cardiac index will be measured using Non-Invasive Cardiac Output Monitoring (Cheetah), 4 weeks | Other: Evolume, The change in extracellular fluid volume from baseline to 4 weeks, measured by multifrequency bioimpedance spectroscopy and normalized to total body weight, 4 weeks
Sponsor/Collaborators: Sponsor: VA Office of Research and Development
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 0
Study Type: INTERVENTIONAL
Study Designs: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2020-08-11
Completion Date: 2020-08-11
Results First Posted:
Last Update Posted: 2021-12-09
Locations: VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX, Dallas, Texas, 75216, United States
URL: https://clinicaltrials.gov/show/NCT04192110