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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02989298
Other study ID # PD registry
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date December 2013
Est. completion date December 2026

Study information

Verified date October 2020
Source Sun Yat-sen University
Contact Xueqing Yu, M.D. & Ph.D.
Phone 8620-87766335
Email yuxq@mail.sysu.edu.cn
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

Brief Summary: The investigators are registering all PD patients at recruited hospitals and developing a PD database in China. Patients will be followed up every 3 months, and both baseline and follow-up information will be collected and input into the registration system. The patient survival, technical survival, peritonitis rate, longitudinal changes of residual renal function and peritoneum function, and quality of life for PD patients, etc, will be compared using the PD database.


Description:

Detailed Description: The investigators are registering all end stage renal disease (ESRD) patients receiving peritoneal dialysis (PD) treatment, and developing a PD database in China. Patients' demographic characteristics (including age, gender, height, weight, BMI, smoking, drinking, and education, etc), clinical characteristics (primary cause of ESRD, dialysis prescription, patient's condition and lab measurements of serum, urine, and dialysate), drug information, complications and scores of quality of life at the baseline will be collected. Patients will be followed up every 3 months. Demographic and clinical characteristics, complications, drug information of patients will be collected at each visit. The patients' clinical outcomes, such as mortality (including all-cause mortality and cardiovascular disease mortality), technical survival, kidney transplantation, transfer to hemodialysis, hospitalization, occurrence of peritonitis, etc. were also followed up till the end of the study. The data of patient survival, technical survival, peritonitis rate, hospitalization rate, clinical lab parameters, longitudinal changes of residual renal function and peritoneum function, peritonitis rate, hospitalization rate, clinical lab parameters and quality of life for PD patients will be analyzed using the PD database.


Recruitment information / eligibility

Status Recruiting
Enrollment 10000
Est. completion date December 2026
Est. primary completion date December 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:PD patients - Exclusion Criteria:No -

Study Design


Related Conditions & MeSH terms

  • Disorders Associated With Peritoneal Dialysis
  • ESRD

Intervention

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

Locations

Country Name City State
China The First Affiliated Hospital, Sun Yat-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 PD patients Patient survival including all-cause and cardiovascular mortality. 10 years
Secondary Technical survival of PD patients 10 years
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