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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04967547
Other study ID # self-care PD ability
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date January 2022
Est. completion date December 31, 2024

Study information

Verified date July 2021
Source Shanghai Jiao Tong University School of Medicine
Contact Na Jiang, MD
Phone +86-21-53882014
Email Jiangjiang198311@163.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Peritoneal dialysis is an effective renal replacement therapy with higher quality of life and lower treatment cost than hemodialysis.However, the application rate of peritoneal dialysis is much lower than that of hemodialysis. One of the reasons is that patients need to complete fluid changing operation independently, which is especially challenging for elderly and frail patients. Assisted peritoneal dialysis can help patients with independent dialysis disorders to complete dialysis. Currently, there is a lack of standard tools to assess patients' ability to conduct independent dialysis and to determine whether assisted dialysis is needed. Moreover, routine assessment is arranged after the training of dialysis operation, which leads to some patients giving up the procedure at an early stage, resulting in a low selection rate of the procedure.The purpose of this study was to investigate the effect of using a standard scale to evaluate the ability to perform abdominal dialysis in patients with stage 5 chronic kidney disease (CKD) before deciding on dialysis modality.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 232
Est. completion date December 31, 2024
Est. primary completion date December 31, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. Age >=18 years old; 2. Need dialysis within 6 months; 3. Informed consent. Exclusion Criteria: 1. Absolute PD contraindications; 2. Need urgent dialysis; 3. RTX as initial renal replacement therapy.

Study Design


Intervention

Other:
Self-care PD ability assessment form
Subjects will be evaluated using the self-care PD feasibility assessment tool within 7 days after randomization. The evaluation results will be provided to the patient on the same day
Education
Education on renal replacement therapy and dialysis

Locations

Country Name City State
China Shanghai Renji Hospital, Shanghai Jiaotong University School of Medicine Shanghai Shanghai

Sponsors (1)

Lead Sponsor Collaborator
Shanghai Jiao Tong University School of Medicine

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary The rate of PD choice up to 90 days
Secondary The aPD utilization rate up to 180 days
See also
  Status Clinical Trial Phase
Terminated NCT00616902 - The PRIMO II Study: Paricalcitol Injection Benefits in Renal Failure Induced Cardiac Morbidity in Subjects With Chronic Kidney Disease (CKD) Stage 5 Phase 3
Recruiting NCT05465044 - Incremental Hemodialysis for Veterans in the First Year of Dialysis (IncHVets) N/A