A Multi-center Prospective Cohort Study Based on Peritoneal Dialysis Telemedicine-assisted Platform
- Conditions
- Peritoneal Dialysis
- Registration Number
- NCT03571451
- Lead Sponsor
- Peking University First Hospital
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 7000
- End-stage renal disease patients receiving maintenance peritoneal dialysis;
- more than 14 years old
- receiving temporary PD due to acute kidney injury
- loss to follow up without any outcomes recorded.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method All-cause death 10 years 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.
Transfer to hemodialysis 10 years 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.
- Secondary Outcome Measures
Name Time Method Exit-site/tunnel infection 10 years The incidence of exit-site/tunnel infection during the time frame. Includes organism-specific, infection-related death or transfer to hemodialysis.
others 10 years The incidence of other complications during the time frame, such as new-onset diabetes/cancer, and encapsulating peritoneal sclerosis.
Other causes for terminating PD 10 years 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.
Peritonitis 10 years 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.
Cardiovascular events 10 years 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.
Abdominal wall complications 10 years The incidence of abdominal wall complications occurred during the time frame, such as peritoneal leaks and hernia.
Trial Locations
- Locations (27)
The second affiliated hospital of Harbin Medical University
🇨🇳Harbin, Heilongjiang, China
Pingdingshan People's Hospital No.1
🇨🇳Pingdingshan, Henan, China
First affiliated hospital of Zhengzhou University
🇨🇳Zhengzhou, Henan, China
The first affiliated hospital of Baotou Medical College
🇨🇳Baotou, Inner Mongolia, China
The first hospital of Jilin University
🇨🇳Changchun, Jilin, China
Shengjing hospital affiliated to China Medical University
🇨🇳Liaoyang, Liaoning, China
People's Hospital of Gansu Province
🇨🇳Lanzhou, Gansu, China
Cangzhou central hospital
🇨🇳Cangzhou, Hebei, China
Taiyuan central hospital
🇨🇳Taiyuan, Shanxi, China
The second hospital of Shanxi Medical University
🇨🇳Taiyuan, Shanxi, China
People's hospital of Cangzhou
🇨🇳Cangzhou, Hebei, China
Beijing haidian hospital
🇨🇳Beijing, China
People's hospital of Langfang
🇨🇳Langfang, Hebei, China
The second hospital of Hebei medical university
🇨🇳Shijiazhuang, Hebei, China
People's Hospitel of Qinghai Province
🇨🇳Xining, Qinghai, China
Xinqiao hospital of the Third Military Medical University
🇨🇳Chongqing, China
Beijing miyun district hospital
🇨🇳Beijing, China
The second affiliated hospital of Anhui Medical University
🇨🇳Hefei, Anhui, China
Peking University Shenzhen Hospital
🇨🇳Shenzhen, Guangdong, China
Handan Central Hospital
🇨🇳Handan, Hebei, China
The third hospital of Hebei Medical University
🇨🇳Shijiazhuang, Hebei, China
The first people's hospital of Xining
🇨🇳Xining, Qinghai, China
The People's Hospital of Chuxiong Yi Autonomous Prefecture
🇨🇳Chuxiong, Yunnan, China
Beijing Charity Hospital
🇨🇳Beijing, China
Beijing dongzhimen Hospital
🇨🇳Beijing, China
Peking University People's Hospital
🇨🇳Beijing, China
Peking University First Hospital
🇨🇳Beijing, Beijing, China