T Cell Dysfunction in ESRD

• Conditions: ESRD; T-Cell Dysfunction
• Interventions: Other: no specific interventions

• Registration Number: NCT04658069
• Lead Sponsor: Shanghai Zhongshan Hospital

Brief Summary

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

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.

Study Timeline

• Status Verified: 2020-12
• Study First Submitted: 2020-12-01
• Study First Submitted QC: 2020-12-01
• Last Update Submitted: 2020-12-01
• Study First Posted: 2020-12-08
• Last Update Posted: 2020-12-08
• Study Start: 2021-01-01
• Primary Completion: 2023-12-31
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 400

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
One Cohort receiving routine hemodialysis therapy without any specific interventions	no specific interventions	all HD patients enrolled in this study

Primary Outcome Measures

Name	Time	Method
Death	January 2021 to December 2023	mortality during the study

Secondary Outcome Measures

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