Peritoneal Dialysis Registration System (PERSIST)

Sponsor

Sun Yat-sen University (Other)

Overall Status

Recruiting

CT.gov ID

NCT02989298

Collaborator

(none)

10,000

Enrollment

Location

156

Duration (Months)

64.1

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
ESRD Disorders Associated With Peritoneal Dialysis	Other: No intervention

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 Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

10000 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Peritoneal Dialysis Registration System (PERSIST)

Study Start Date :

Dec 1, 2013

Anticipated Primary Completion Date :

Dec 1, 2026

Anticipated Study Completion Date :

Dec 1, 2026

Arms and Interventions

Arm	Intervention/Treatment
PD patients End stage renal disease patients receiving peritoneal dialysis treatment	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.

Arm

Intervention/Treatment

PD patients

End stage renal disease patients receiving peritoneal dialysis treatment

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.

Outcome Measures

Primary Outcome Measures

Patient survival of PD patients [10 years]
Patient survival including all-cause and cardiovascular mortality.

Secondary Outcome Measures

Technical survival of PD patients [10 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:PD patients -

Exclusion Criteria:No

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The First Affiliated Hospital, Sun Yat-sen University	Guangzhou	Guangdong	China	510080

Sponsors and Collaborators

Sun Yat-sen University

Investigators

Principal Investigator: Xueqing Yu, M.D. & Ph.D., First Affiliated Hospital, Sun Yat-Sen University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Xue Qing Yu, Professor, Sun Yat-sen University

ClinicalTrials.gov Identifier:

NCT02989298

Other Study ID Numbers:

PD registry

First Posted:

Dec 12, 2016

Last Update Posted:

Oct 22, 2020

Last Verified:

Oct 1, 2020

Keywords provided by Xue Qing Yu, Professor, Sun Yat-sen University

Peritoneal Dialysis (PD)

Residual renal function

Study Results

No Results Posted as of Oct 22, 2020