Status:
NOT_YET_RECRUITING
Dynamic Breath VOC Profiling as a Non-invasive Tool to Assess Hemodialysis Adequacy
Lead Sponsor:
Second People's Hospital, Shanghai
Conditions:
Uremia
Uremia; Chronic
Eligibility:
All Genders
18-85 years
Brief Summary
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 wo...
Detailed Description
Rationale and Background Adequacy of hemodialysis (HD) is commonly summarized by small-solute clearance metrics such as Kt/V. However, patient-centered outcomes do not always improve with higher urea ...
Eligibility Criteria
Inclusion
- 1: Age:18-85
- 2: Maintenance hemodialysis (HD) group: diagnosed with chronic kidney disease stage 5 (uremia), receiving regular HD for ≥3 months.
- 3: Healthy control group: with no history of major acute or chronic diseases.
- 4: Capable of understanding the research procedures and voluntarily providing written informed consent.
- Active infection
- History or current diagnosis of malignancy
- Severe hepatic insufficiency
- Unable to comply with breath testing or blood sampling; or refusal or inability to provide informed consent.
- Deemed ineligible for participation based on the investigator's judgment.
Exclusion
Key Trial Info
Start Date :
September 30 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 30 2027
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT07189741
Start Date
September 30 2025
End Date
June 30 2027
Last Update
September 24 2025
Active Locations (1)
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1
Shanghai Second People's Hospital
Shanghai, Shanghai Municipality, China, 200011