Clinical trial NCT03571451: A Multi-center Prospective Cohort Study Based on Peritoneal Dialysis Telemedicine-assisted Platform
Official title: A Multi-center Prospective Cohort Study Based on Peritoneal Dialysis Telemedicine-assisted Platform
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Peritoneal Dialysis
Keywords: peritoneal dialysis
survival rate
technique survival rate
risk factors
end stage renal disease
Lead sponsor: Peking University First Hospital
Sponsor class: OTHER
Collaborators: name: The Second Hospital of Hebei Medical University
name: Army Medical University, China
name: The First Affiliated Hospital of Zhengzhou University
name: Hebei Medical University Third Hospital
name: Peking University Shenzhen Hospital
name: Handan Central Hospital
name: Beijing Haidian Hospital
name: People's Hospital of Qinghai Province
name: Cangzhou Central Hospital
name: The Second Affiliated Hospital of Harbin Medical University
name: Shengjing Hospital
name: The Second Hospital of Anhui Medical University
name: Peking University People's Hospital
name: The First Affiliated Hospital of BaoTou Medical College
name: The People's Hospital of Chuxiong Yi Autonomous Prefecture
name: Beijing miyun district hospital
name: Second Hospital of Shanxi Medical University
name: People's Hospital of Gansu
name: Pingdingshan first people's Hospital
name: The first people's hospital of Xining
name: The First Hospital of Jilin University
name: Cangzhou People's Hospital
name: Taiyuan central hospital
name: People's hospital of Langfang
name: China Rehabilitation Research Center
name: Dongzhimen Hospital, Beijing
name: Department of Epidemiology and Biostatistics, School of Public Health, Peking University
name: Department of Statistics, Peking University First Hospital
First posted: 2018-06-27
Enrollment: 7000
Sex: ALL
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with end-stage renal disease receiving maintenance peritoneal dialysis

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: All-cause death
timeFrame: 10 years
measure: Transfer to hemodialysis
timeFrame: 10 years
Secondary outcomes:
measure: Peritonitis
timeFrame: 10 years
measure: Exit-site/tunnel infection
timeFrame: 10 years
measure: Cardiovascular events
timeFrame: 10 years
measure: Abdominal wall complications
timeFrame: 10 years
measure: others
timeFrame: 10 years
measure: Other causes for terminating PD
timeFrame: 10 years
Other outcomes:
Locations:
city: Hefei
country: China
facility: The second affiliated hospital of Anhui Medical University
state: Anhui
city: Beijing
country: China
facility: Peking University First Hospital
state: Beijing
city: Lanzhou
country: China
facility: People's Hospital of Gansu Province
state: Gansu
city: Shenzhen
country: China
facility: Peking University Shenzhen Hospital
state: Guangdong
city: Cangzhou
country: China
facility: Cangzhou central hospital
state: Hebei
city: Cangzhou
country: China
facility: People's hospital of Cangzhou
state: Hebei
city: Handan
country: China
facility: Handan Central Hospital
state: Hebei
city: Langfang
country: China
facility: People's hospital of Langfang
state: Hebei
city: Shijiazhuang
country: China
facility: The second hospital of Hebei medical university
state: Hebei
city: Shijiazhuang
country: China
facility: The third hospital of Hebei Medical University
state: Hebei
city: Harbin
country: China
facility: The second affiliated hospital of Harbin Medical University
state: Heilongjiang
city: Pingdingshan
country: China
facility: Pingdingshan People's Hospital No.1
state: Henan
city: Zhengzhou
country: China
facility: First affiliated hospital of Zhengzhou University
state: Henan
city: Baotou
country: China
facility: The first affiliated hospital of Baotou Medical College
state: Inner Mongolia
city: Changchun
country: China
facility: The first hospital of Jilin University
state: Jilin
city: Liaoyang
country: China
facility: Shengjing hospital affiliated to China Medical University
state: Liaoning
city: Xining
country: China
facility: People's Hospitel of Qinghai Province
state: Qinghai
city: Xining
country: China
facility: The first people's hospital of Xining
state: Qinghai
city: Taiyuan
country: China
facility: Taiyuan central hospital
state: Shanxi
city: Taiyuan
country: China
facility: The second hospital of Shanxi Medical University
state: Shanxi
city: Chuxiong
country: China
facility: The People's Hospital of Chuxiong Yi Autonomous Prefecture
state: Yunnan
city: Beijing
country: China
facility: Beijing Charity Hospital
city: Beijing
country: China
facility: Beijing dongzhimen Hospital
city: Beijing
country: China
facility: Beijing haidian hospital
city: Beijing
country: China
facility: Beijing miyun district hospital
city: Beijing
country: China
facility: Peking University People's Hospital
city: Chongqing
country: China
facility: Xinqiao hospital of the Third Military Medical University
Study officials:
References: