- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02989298
Peritoneal Dialysis Registration System (PERSIST)
October 20, 2020 updated by: Xue Qing Yu, Sun Yat-sen University
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.
Study Overview
Status
Recruiting
Intervention / Treatment
Detailed 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.
Study Type
Observational
Enrollment (Anticipated)
10000
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Xueqing Yu, M.D. & Ph.D.
- Phone Number: 8620-87766335
- Email: yuxq@mail.sysu.edu.cn
Study Contact Backup
- Name: Xiao Yang, M.D. & Ph.D.
- Phone Number: 8843 8620-87755766
- Email: yangxsysu@126.com
Study Locations
-
-
Guangdong
-
Guangzhou, Guangdong, China, 510080
- Recruiting
- The First Affiliated Hospital, Sun Yat-sen University
-
Contact:
- Xueqing Yu, M.D. & Ph.D
- Phone Number: 8620-87766335
- Email: yuxq@mail.sysu.edu.cn
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
ESRD patients receiving PD treatment
Description
Inclusion Criteria:PD patients -
Exclusion Criteria:No
-
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
PD patients
End stage renal disease patients receiving peritoneal dialysis treatment
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Patient survival of PD patients
Time Frame: 10 years
|
Patient survival including all-cause and cardiovascular mortality.
|
10 years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Technical survival of PD patients
Time Frame: 10 years
|
10 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Xueqing Yu, M.D. & Ph.D., First Affiliated Hospital, Sun Yat-Sen University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2013
Primary Completion (Anticipated)
December 1, 2026
Study Completion (Anticipated)
December 1, 2026
Study Registration Dates
First Submitted
October 17, 2016
First Submitted That Met QC Criteria
December 7, 2016
First Posted (Estimate)
December 12, 2016
Study Record Updates
Last Update Posted (Actual)
October 22, 2020
Last Update Submitted That Met QC Criteria
October 20, 2020
Last Verified
October 1, 2020
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- PD registry
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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