T Cell Dysfunction in ESRD

Study Overview
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Brief Summary
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Patients with end-stage renal disease (ESRD) suffer from high morbidity and mortality of cardiovascular and infectious disease and increased risk of all-cause mortality which is mainly attributed to the disturbed immune response. More and more evident indicated that T cell dysfunction was universal in ESRD. However, few studies clarified the association of T cell dysfunction and clinical outcomes. This study is aim to explore valuable markers of T cell dysfunction predicting bad clinical outcomes including death, cardiovascular disease, infection and tumor. Hopefully, these finding will provide foundation for further mechanism research and better therapeutic options for ESRD patients in the future.

Detailed Description
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Patients with end-stage renal disease (ESRD) suffer from high morbidity and mortality of cardiovascular and infectious disease and increased risk of all-cause mortality which is mainly attributed to the disturbed immune response. More and more evident indicated that T cell dysfunction was universal in ESRD. Recent evidence suggests uremia-related immune changes resemble to aging immune system, increasing immunological age of T cells by 20-30 years. As compared to an age-matched healthy control, ESRD patients present a lower thymic output of naïve T cells, a decline in the T-cell telomere length and an increase in the differentiation status towards the terminal differentiated memory phenotype with a large number of CD28-negative T cells. More importantly, these changes are strongly associated with a history of cardiovascular diseases and the occurrence of severe infectious episodes in this population, supporting the idea that T cell dysfunction is a critical feature in this population and will impact clinical outcomes profoundly. This study prospectively researched the predictive value of T cell dysfunction for all-cause mortality and clinical complication in hemodialysis (HD) patients.

Official Title
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T Cell Dysfunction in End-stage Renal Disease

Conditions
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ESRD, T-Cell Dysfunction

Intervention / Treatment
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* Other: no specific interventions


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: had been on hemodialysis treatment for at least 6 months in Blood Purification Center,Zhongshan Hospital, Fudan University Exclusion Criteria: underwent any kind of cardiovascular or infection event in three months with hematological diseases, rheumatic diseases, active malignancies with history of human immunodeficiency virus infection currently use of any immunosuppressants not followed-up at Zhongshan Hospital, Fudan University

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| One Cohort receiving routine hemodialysis therapy without any specific interventions<br>all HD patients enrolled in this study | Other: no specific interventions<br>* no specific interventions<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Death | mortality during the study | January 2021 to December 2023 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiovascular disease | having documented congestive heart failure, coronary artery disease, peripheral arterial occlusive disease, or stroke | January 2021 to December 2023 | 
| Infection event | having new onset of infections which requiring standard intravenous antibiotics or hospitalization | January 2021 to December 2023 | 
| Cancer | having new discovered tumors | January 2021 to December 2023 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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T cell dysfunction, end-stage renal disease, clinical outcome