A Multi-center Prospective Cohort Study Based on Peritoneal Dialysis Telemedicine-assisted Platform (PDTAP)

Increasing the proportion of patients on peritoneal dialysis (PD) may relieve the financial burden caused by the growing number of patients with end-stage renal disease (ESRD). The investigators are developing a PD database in China using peritoneal dialysis telemedicine-assisted platform (PD TAP). The survival rate and technique survival rate of PD patients, as well as risk factors associated with survival and technique survival will be analyzed through PD TAP.

Study Overview

• Status: Recruiting
• Conditions: Peritoneal Dialysis

Detailed Description

The growing number of patients with ESRD leads to an increasing medical burden all around the world. Patients on PD have a similar long-term survival rate as patients on hemodialysis, with a much lower cost of medical resources. Therefore, increasing the percentage of patients on PD may relieve the increasing financial burden for the whole society.

Of note, technique survival and patient survival in PD still need to be improved. Based on results from multi-center cohort studies, some prognostic factors have been explored and intervened in recent years. However, robust data from large samples on potential predictors pertaining to patients' clinical characteristics, and PD practice on clinical outcomes in the real world is still limited. This phenomenon calls an action on exploring novel risk factors of patient outcome, especially through national-level prospective cohort study.

The investigators are developing a national-level PD database by registering all patients receiving PD on PD TAP. The study is underway in 27 hospitals from 14 provinces located at 7 geographical regions (northwest, northeast, north, central, southwest, southeast and south) in China. National samples of PD units are recruited based on the availability of professional PD team who is willing participant and could regularly follow participants. Our study aims to enroll adult 7,000 patients with end stage renal disease receiving PD. Patients-, treatment- and telemedicine-level variables are collected at baseline and thus at 3-month intervals. PD practice surveys are collected at baseline. All-cause mortality and transfer to hemodialysis will be recorded as primary outcomes. Other clinical outcomes including infectious and non-infectious complications would be recorded. Apart from the above objectives, potential collaboration between PDTAP and local or international clinical research could develop ancillary studies with specific aims. Examples of key research and ancillary investigation proposed in PDTAP study are as follows: 1) Long-term effects of telemedicine on clinical outcomes of patients on PD: a propensity matched study, 2) Anemia, erythrocyte-stimulating agents, inflammation and the association with mortality in patients on PD, 3) The management of serum calcium, phosphate, and hyperparathyroidism and its relationship with mortality in patients on PD, 4) The prevalence of hypomagnesemia, and all-cause and cardiovascular mortality in patients on PD, 5) The prevalence, predictors, and outcomes of PD-related peritonitis, 6) Association between hemoglobin levels and serum albumin levels and mortality in diabetic and non-diabetic patients on PD, 7) Glucose absorption (measured as the difference between the amount of glucose in peritoneal dialysate absorbed into the peritoneal cavity in 24h and that measured in the 24h drained effluent) and its association with metabolic syndrome, cardiovascular events, and mortality in patients on PD. The follow-up will be continued until the end of the study.

• Study Type: Observational
• Enrollment (Estimated): 7000

Contacts and Locations

• Study Contact: Name: Jie Dong, MD,Ph.D.; Phone Number: 086-010-83572388; Email: jie.dong@bjmu.edu.cn
• Study Contact Backup: Name: Tian-tian Ma, MD; Phone Number: 086-010-83572388

Study Locations

• China
  • Beijing, China
    • Recruiting
    • Peking University People's Hospital
  • Beijing, China
    • Recruiting
    • Beijing Haidian Hospital
  • Beijing, China
    • Recruiting
    • Beijing Charity Hospital
  • Beijing, China
    • Recruiting
    • Beijing dongzhimen Hospital
  • Beijing, China
    • Recruiting
    • Beijing miyun district hospital
  • Chongqing, China
    • Recruiting
    • Xinqiao Hospital of the Third Military Medical University
  • Anhui
    • Hefei, Anhui, China
      • Recruiting
      • The Second Affiliated Hospital of Anhui Medical University
  • Beijing
    • Beijing, Beijing, China, 100034
      • Recruiting
      • Peking University First Hospital
      • Contact: Jie Dong, MD, Ph.D.; Phone Number: 086-010-83572388; Email: jie.dong@bjmu.edu.cn
  • Gansu
    • Lanzhou, Gansu, China
      • Recruiting
      • People's Hospital of Gansu Province
  • Guangdong
    • Shenzhen, Guangdong, China
      • Recruiting
      • Peking University Shenzhen Hospital
  • Hebei
    • Cangzhou, Hebei, China
      • Recruiting
      • Cangzhou Central Hospital
      • Contact: Nan Zhao, MD
    • Cangzhou, Hebei, China
      • Recruiting
      • People's hospital of Cangzhou
    • Handan, Hebei, China
      • Recruiting
      • Handan Central Hospital
    • Langfang, Hebei, China
      • Recruiting
      • People's hospital of Langfang
    • Shijiazhuang, Hebei, China
      • Recruiting
      • The Second Hospital of Hebei Medical University
    • Shijiazhuang, Hebei, China
      • Recruiting
      • The Third Hospital of Hebei Medical University
  • Heilongjiang
    • Harbin, Heilongjiang, China
      • Recruiting
      • The Second Affiliated Hospital of Harbin Medical University
  • Henan
    • Pingdingshan, Henan, China
      • Recruiting
      • Pingdingshan People's Hospital No.1
      • Contact: Xianzhao Zhang, MD
    • Zhengzhou, Henan, China
      • Recruiting
      • First Affiliated Hospital of Zhengzhou University
  • Inner Mongolia
    • Baotou, Inner Mongolia, China
      • Recruiting
      • The First Affiliated Hospital of Baotou Medical College
  • Jilin
    • Changchun, Jilin, China
      • Recruiting
      • The First Hospital of Jilin University
  • Liaoning
    • Liaoyang, Liaoning, China
      • Recruiting
      • Shengjing Hospital affiliated to China Medical University
  • Qinghai
    • Xining, Qinghai, China
      • Recruiting
      • People's Hospitel of Qinghai Province
    • Xining, Qinghai, China
      • Recruiting
      • The first people's hospital of Xining
  • Shanxi
    • Taiyuan, Shanxi, China
      • Recruiting
      • The Second Hospital of Shanxi Medical University
    • Taiyuan, Shanxi, China
      • Recruiting
      • Taiyuan Central Hospital
  • Yunnan
    • Chuxiong, Yunnan, China
      • Recruiting
      • The People's Hospital of Chuxiong Yi Autonomous Prefecture
      • Contact: Wenxi Zhao, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients with end-stage renal disease receiving maintenance peritoneal dialysis

Description

Inclusion Criteria:

• End-stage renal disease patients receiving maintenance peritoneal dialysis;
• more than 14 years old

Exclusion Criteria:

• receiving temporary PD due to acute kidney injury
• loss to follow up without any outcomes recorded.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
All-cause death	All-cause death refers to the number of patients who died within the anticipated time frame. For example death caused by CVD, systemic infection, malignancies (according to the WHO classification), and protein-energy wasting.	10 years
Transfer to hemodialysis	Transfer to hemodialysis refers to the number of patients who were Transfer to hemodialysis from PD due to any cause within the anticipated time frame. For example, caused by dialysis inadequacy, volume overload, infection-related (peritonitis and exitsite infection), catheter dysfunction (catheter blockage and displacement), ultrafiltration failure, et al.	10 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Peritonitis	The incidence of peritoneal dialysis related peritonitis during the time frame. Includes first-episode/multi-episode, refractory, relapsing, repeat, and recurrent, organism-specific, peritonitis-related death or transfer to hemodialysis.	10 years
Exit-site/tunnel infection	The incidence of exit-site/tunnel infection during the time frame. Includes organism-specific, infection-related death or transfer to hemodialysis.	10 years
Cardiovascular events	The incidence of cardiovascular events during the time frame. For example, caused by congestive heart failure, angina or acute myocardial infarction, cerebrovascular accident, and peripheral arterial events.	10 years
Abdominal wall complications	The incidence of abdominal wall complications occurred during the time frame, such as peritoneal leaks and hernia.	10 years
others	The incidence of other complications during the time frame, such as new-onset diabetes/cancer, and encapsulating peritoneal sclerosis.	10 years
Other causes for terminating PD	The incidence of other causes for terminating PD during the time frame. For example, caused by kidney transplantation, burnout, caretaker burnout or absence physical handicap preventing self-care.	10 years

Collaborators and Investigators

• Sponsor: Peking University First Hospital
• Collaborators: Peking University People's Hospital; The Second Hospital of Hebei Medical University; Shengjing Hospital; The First Affiliated Hospital of Zhengzhou University; The First Hospital of Jilin University; Dongzhimen Hospital, Beijing; Peking University Shenzhen Hospital; The Second Affiliated Hospital of Harbin Medical University; Hebei Medical University Third Hospital; Cangzhou Central Hospital; China Rehabilitation Research Center; Beijing Haidian Hospital; Second Hospital of Shanxi Medical University; The Second Hospital of Anhui Medical University; The First Affiliated Hospital of BaoTou Medical College; Taiyuan central hospital; Cangzhou People's Hospital; People's Hospital of Qinghai Province; Handan Central Hospital; Xinqiao hospital of Army Medical University; The People's Hospital of Chuxiong Yi Autonomous Prefecture; Beijing miyun district hospital; People's Hospital of Gansu; Pingdingshan first people's Hospital; The first people's hospital of Xining; People's hospital of Langfang; Department of Epidemiology and Biostatistics, School of Public Health, Peking University; Department of Statistics, Peking University First Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2016
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: June 20, 2018
• First Submitted That Met QC Criteria: June 22, 2018
• First Posted (Actual): June 27, 2018

Study Record Updates

• Last Update Posted (Actual): October 25, 2023
• Last Update Submitted That Met QC Criteria: October 23, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: risk factors; peritoneal dialysis; end stage renal disease; survival rate; technique survival rate
• Other Study ID Numbers: PDTAP study

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No