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

NCT ID: NCT03571451

Last Updated: 2023-10-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

7000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-06-01

Study Completion Date

2025-12-01

Brief Summary

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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

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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.

Conditions

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Peritoneal Dialysis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.
Minimum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Second Hospital of Hebei Medical University

OTHER

Sponsor Role collaborator

Army Medical University, China

OTHER

Sponsor Role collaborator

The First Affiliated Hospital of Zhengzhou University

OTHER

Sponsor Role collaborator

Hebei Medical University Third Hospital

OTHER

Sponsor Role collaborator

Peking University Shenzhen Hospital

OTHER

Sponsor Role collaborator

Handan Central Hospital

OTHER

Sponsor Role collaborator

Beijing Haidian Hospital

OTHER

Sponsor Role collaborator

People's Hospital of Qinghai Province

UNKNOWN

Sponsor Role collaborator

Cangzhou Central Hospital

OTHER

Sponsor Role collaborator

The Second Affiliated Hospital of Harbin Medical University

OTHER

Sponsor Role collaborator

Shengjing Hospital

OTHER

Sponsor Role collaborator

The Second Hospital of Anhui Medical University

OTHER

Sponsor Role collaborator

Peking University People's Hospital

OTHER

Sponsor Role collaborator

The First Affiliated Hospital of BaoTou Medical College

OTHER

Sponsor Role collaborator

The People's Hospital of Chuxiong Yi Autonomous Prefecture

UNKNOWN

Sponsor Role collaborator

Beijing miyun district hospital

UNKNOWN

Sponsor Role collaborator

Second Hospital of Shanxi Medical University

OTHER

Sponsor Role collaborator

People's Hospital of Gansu

UNKNOWN

Sponsor Role collaborator

Pingdingshan first people's Hospital

UNKNOWN

Sponsor Role collaborator

The first people's hospital of Xining

UNKNOWN

Sponsor Role collaborator

The First Hospital of Jilin University

OTHER

Sponsor Role collaborator

Cangzhou People's Hospital

OTHER

Sponsor Role collaborator

Taiyuan central hospital

UNKNOWN

Sponsor Role collaborator

People's hospital of Langfang

UNKNOWN

Sponsor Role collaborator

China Rehabilitation Research Center

OTHER_GOV

Sponsor Role collaborator

Dongzhimen Hospital, Beijing

OTHER

Sponsor Role collaborator

Department of Epidemiology and Biostatistics, School of Public Health, Peking University

UNKNOWN

Sponsor Role collaborator

Department of Statistics, Peking University First Hospital

UNKNOWN

Sponsor Role collaborator

Peking University First Hospital

OTHER

Sponsor Role lead

Responsible Party

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Dong Jie

Director of Peritoneal dialysis center

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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The second affiliated hospital of Anhui Medical University

Hefei, Anhui, China

Site Status RECRUITING

Peking University First Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

People's Hospital of Gansu Province

Lanzhou, Gansu, China

Site Status RECRUITING

Peking University Shenzhen Hospital

Shenzhen, Guangdong, China

Site Status RECRUITING

Cangzhou central hospital

Cangzhou, Hebei, China

Site Status RECRUITING

People's hospital of Cangzhou

Cangzhou, Hebei, China

Site Status RECRUITING

Handan Central Hospital

Handan, Hebei, China

Site Status RECRUITING

People's hospital of Langfang

Langfang, Hebei, China

Site Status RECRUITING

The second hospital of Hebei medical university

Shijiazhuang, Hebei, China

Site Status RECRUITING

The third hospital of Hebei Medical University

Shijiazhuang, Hebei, China

Site Status RECRUITING

The second affiliated hospital of Harbin Medical University

Harbin, Heilongjiang, China

Site Status RECRUITING

Pingdingshan People's Hospital No.1

Pingdingshan, Henan, China

Site Status RECRUITING

First affiliated hospital of Zhengzhou University

Zhengzhou, Henan, China

Site Status RECRUITING

The first affiliated hospital of Baotou Medical College

Baotou, Inner Mongolia, China

Site Status RECRUITING

The first hospital of Jilin University

Changchun, Jilin, China

Site Status RECRUITING

Shengjing hospital affiliated to China Medical University

Liaoyang, Liaoning, China

Site Status RECRUITING

People's Hospitel of Qinghai Province

Xining, Qinghai, China

Site Status RECRUITING

The first people's hospital of Xining

Xining, Qinghai, China

Site Status RECRUITING

Taiyuan central hospital

Taiyuan, Shanxi, China

Site Status RECRUITING

The second hospital of Shanxi Medical University

Taiyuan, Shanxi, China

Site Status RECRUITING

The People's Hospital of Chuxiong Yi Autonomous Prefecture

Chuxiong, Yunnan, China

Site Status RECRUITING

Beijing Charity Hospital

Beijing, , China

Site Status RECRUITING

Beijing dongzhimen Hospital

Beijing, , China

Site Status RECRUITING

Beijing haidian hospital

Beijing, , China

Site Status RECRUITING

Beijing miyun district hospital

Beijing, , China

Site Status RECRUITING

Peking University People's Hospital

Beijing, , China

Site Status RECRUITING

Xinqiao hospital of the Third Military Medical University

Chongqing, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Jie Dong, MD,Ph.D.

Role: CONTACT

086-010-83572388

Tian-tian Ma, MD

Role: CONTACT

086-010-83572388

Facility Contacts

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Jie Dong, MD, Ph.D.

Role: primary

086-010-83572388

Nan Zhao, MD

Role: primary

Xianzhao Zhang, MD

Role: primary

Wenxi Zhao, MD

Role: primary

References

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Li X, Ma T, Hao J, Song D, Wang H, Liu T, Xu X, Dong J. The relationship between exercise and the occurrence of abdominal wall complications in patients on peritoneal dialysis. BMC Nephrol. 2025 Jul 15;26(1):389. doi: 10.1186/s12882-025-04317-7.

Reference Type DERIVED
PMID: 40665238 (View on PubMed)

Other Identifiers

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PDTAP study

Identifier Type: -

Identifier Source: org_study_id

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