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Dynamic Breath VOC Profiling as a Non-invasive Tool to Assess Hemodialysis Adequacy

Second People's Hospital, Shanghai · 2025
ClinicalTrials.gov · Datasets · License: Public Domain · 2025
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chronichemodialysis
What is this study about? This is an observational study. The goal is to find out whether tiny chemicals in breath, called volatile organic compounds (VOCs), can help show if a hemodialysis session works well enough ("dialysis adequacy"). Hemodialysis is a treatment that uses a machine to remove waste and extra fluid from the blood. Main questions Which breath chemicals change in people receiving hemodialysis when we compare samples collected before dialysis with samples collected after the same dialysis session? Do these changes help indicate whether a dialysis session is adequate (that is, whether it worked as intended)? How do the breath chemicals of people receiving hemodialysis differ from those of healthy adults? During the dialysis session, which blood test results go up or down? Which ones are most different from the usual healthy range? Who can take part Adults aged 18-85 years. Hemodialysis group: people with chronic kidney disease stage 5 who receive maintenance hemodialysis for at least three months. Healthy comparison group: adults without major acute or chronic illnesses. Final eligibility will follow the approved study protocol and screening. What will happen if you join Hemodialysis group Provide one breath sample before a routine dialysis session and one breath sample after the same session. Have a small blood draw at those same time points. Your usual medical care will not change because of this study. Healthy comparison group Provide one breath sample and one small blood draw at a single visit. Time and visits For people receiving hemodialysis: both breath and blood samples are collected around one dialysis session (before and after). For healthy adults: all procedures are finished in one scheduled visit. The study plans to include about 22 people on hemodialysis and about 23 healthy adults. These numbers may change slightly as enrollment proceeds. How your samples are used Breath samples will be analyzed with gas chromatography-mass spectrom
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