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

Peritoneal Dialysis Clinical Trial

— PDTAP  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03571451
• Other study ID #: PDTAP study
• Status: Recruiting
• Start date: June 1, 2016
• Est. completion date: December 1, 2025

Study information

• Verified date: October 2023
• Source: Peking University First Hospital
• Contact: Jie Dong, MD,Ph.D.
• Phone: 086-010-83572388
• Email: jie.dong[@]bjmu.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 7000
• Est. completion date: December 1, 2025
• Est. primary completion date: December 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Peritoneal Dialysis

Locations

Country	Name	City	State
China	The first affiliated hospital of Baotou Medical College	Baotou	Inner Mongolia
China	Beijing Charity Hospital	Beijing
China	Beijing dongzhimen Hospital	Beijing
China	Beijing haidian hospital	Beijing
China	Beijing miyun district hospital	Beijing
China	Peking University First Hospital	Beijing	Beijing
China	Peking University People's Hospital	Beijing
China	Cangzhou central hospital	Cangzhou	Hebei
China	People's hospital of Cangzhou	Cangzhou	Hebei
China	The first hospital of Jilin University	Changchun	Jilin
China	Xinqiao hospital of the Third Military Medical University	Chongqing
China	The People's Hospital of Chuxiong Yi Autonomous Prefecture	Chuxiong	Yunnan
China	Handan Central Hospital	Handan	Hebei
China	The second affiliated hospital of Harbin Medical University	Harbin	Heilongjiang
China	The second affiliated hospital of Anhui Medical University	Hefei	Anhui
China	People's hospital of Langfang	Langfang	Hebei
China	People's Hospital of Gansu Province	Lanzhou	Gansu
China	Shengjing hospital affiliated to China Medical University	Liaoyang	Liaoning
China	Pingdingshan People's Hospital No.1	Pingdingshan	Henan
China	Peking University Shenzhen Hospital	Shenzhen	Guangdong
China	The second hospital of Hebei medical university	Shijiazhuang	Hebei
China	The third hospital of Hebei Medical University	Shijiazhuang	Hebei
China	Taiyuan central hospital	Taiyuan	Shanxi
China	The second hospital of Shanxi Medical University	Taiyuan	Shanxi
China	People's Hospitel of Qinghai Province	Xining	Qinghai
China	The first people's hospital of Xining	Xining	Qinghai
China	First affiliated hospital of Zhengzhou University	Zhengzhou	Henan

Sponsors (29)

Lead Sponsor

Collaborator

Peking University First Hospital

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

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	Abdominal wall complications	The incidence of abdominal wall complications occurred during the time frame, such as peritoneal leaks and hernia.	10 years
Secondary	others	The incidence of other complications during the time frame, such as new-onset diabetes/cancer, and encapsulating peritoneal sclerosis.	10 years
Secondary	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