Effect of Pre-emptive Assessment of Self-care Peritoneal Dialysis (PD) Ability on PD Choice in Patients With Stage 5 Chronic Kidney Disease

Chronic Kidney Disease (CKD) Stage 5 Clinical Trial

Official title:

Effect of Pre-emptive Assessment of Self-care Peritoneal Dialysis (PD) Ability on PD Choice in Patients With Stage 5 Chronic Kidney Disease

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04967547
• Other study ID #: self-care PD ability
• Status: Not yet recruiting
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Chronic Kidney Disease (CKD) Stage 5
• Kidney Diseases
• Renal Insufficiency, Chronic

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