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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03001921
Other study ID # WISHES
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date December 2013
Est. completion date December 2027

Study information

Verified date October 2020
Source Sun Yat-sen University
Contact Xueqing Yu, M.D. & Ph.D.
Email yuxq@mail.sysu.edu.cn
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

The investigators are registering all HD patients at recruited hospitals and developing a HD database in China. Patients will be follow-up every 3 months, and both baseline and follow-up information will be entered into the registration system. The patient survival, technical survival, patency rate of access, quality of life and residual renal function for HD patients will be compared using the HD database.


Description:

The investigators are registering all end stage renal disease (ESRD) patients receiving hemodialysis (HD) treatment, and developing a HD database in China. Patients' demographic characteristics (including age, gender, height, weight, BMI, smoking, drinking, and education), clinical characteristics (including systolic blood pressure, diastolic blood pressure, primary cause of ESRD, and lab measurements of serum, urine, and access patency), complications, drug information and scores of quality of life at the baseline will be collected. Patients will be follow-up every 3 month, the demographic and clinical characteristics, complications and drug information of patients will be collected at each visit. The investigators also record the outcome at each visit, such as mortality (including all-cause mortality and cardiovascular disease mortality), technical survival, kidney transplantation, transfer to peritoneal dialysis, hospitalization, access failure,etc. The patient survival, technical survival, patency rate of access, quality of life and residual renal function for HD patients will be compared using the HD database.


Recruitment information / eligibility

Status Recruiting
Enrollment 30000
Est. completion date December 2027
Est. primary completion date December 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: End stage renal disease patients receiving hemodialysis treatment. Exclusion Criteria: No

Study Design


Related Conditions & MeSH terms

  • Haemolyses and Related Conditions
  • Hemolysis

Intervention

Other:
No intervention
Registration of all HD patients in the First Affiliated Hospital of Sun Yat-sen University and other hospital which have signed the contract in China.

Locations

Country Name City State
China The 1st Affiliated Hospital, Sun Yet-sen University Guangzhou Guangdong

Sponsors (1)

Lead Sponsor Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Patient survival of HD patients 10 years
Secondary Quality of life evaluated using SF36 scale for HD patients 10 years
Secondary Patency rate of access for HD patients 10 years
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