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

NCT07189741 | Not Yet Recruiting DMC

• 1 other identifier: SC2025-KY-26
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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 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 spectrometry (GC-MS), a laboratory method that separates and identifies very small amounts of chemicals in breath. Blood samples will be tested for routine biochemistry and immune measures to see which results change during dialysis and which results are different from the healthy range. The study does not test a new drug or device and does not change your treatment. Possible benefits You may not receive a direct benefit. The knowledge from this study may help doctors find simple, non-invasive ways to judge whether dialysis works well, which could improve care for people with kidney failure in the future. Possible risks or discomforts Breath collection is non-invasive and usually causes no discomfort. Blood draws may cause brief pain, a small bruise, or lightheadedness in some people. Privacy and data protection We label samples and data with codes instead of names. Only authorized staff can link the codes to your identity. Study results may be published in journals or at meetings, but no information that can identify you will be shared. Where and when Location: Shanghai Second People's Hospital (Department of Nephrology, Dialysis Unit). Study period: September 1, 2025 to June 30, 2027. Sampling is expected during routine care for people on dialysis and during one visit for healthy adults. Study team Principal Investigator: Tao Xiaoyang, Shanghai Second People's Hospital.

Conditions

Uremia; Uremia; Chronic; Hemodialysis

Outcome Measures

Primary Outcomes (1)

• The positive detection rate of characteristic VOCs in the exhaled breath of patients and control group

  1 hour before hemodialysis and 1 hour after hemodialysis completion.

Interventions

hemodialysis PROCEDURE

Three times a week.

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients receiving care at Shanghai Second People's Hospital

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. 1. Active infection 2. History or current diagnosis of malignancy 3. Severe hepatic insufficiency 4. Unable to comply with breath testing or blood sampling; or refusal or inability to provide informed consent. 5. Deemed ineligible for participation based on the investigator's judgment.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Second People's Hospital, Shanghai: lead

Study Sites (1)

Shanghai Second People's Hospital

Shanghai, Shanghai Municipality, 200011, China

Location

MeSH Terms

Conditions

Uremia; Bronchiolitis Obliterans Syndrome

Interventions

Renal Dialysis

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Organizing Pneumonia; Bronchiolitis Obliterans; Bronchiolitis; Bronchitis; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Graft vs Host Disease; Immune System Diseases

Intervention Hierarchy (Ancestors)

Renal Replacement Therapy; Therapeutics; Sorption Detoxification

Central Study Contacts

Tao Xiaoyang

CONTACT

+86 13601956841; 18918857376@189.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 30, 2025
• First Posted: September 24, 2025
• Study Start: September 30, 2025
• Primary Completion: January 1, 2026
• Study Completion (Estimated): June 30, 2027
• Last Updated: September 24, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP

Locations

CN (1)