An Assessment on Current Outcomes of Peritoneal Dialysis in Korea

Kidney Failure, Chronic Clinical Trial

— PDKOREA  

Official title:

An Assessment on Current Outcomes of Peritoneal Dialysis in Korea

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02573675
• Other study ID #: PDKOREA-1
• Status: Not yet recruiting
• Phase: N/A
• First received: October 8, 2015
• Last updated: October 8, 2015
• Start date: November 2015
• Est. completion date: October 2018

Study information

• Verified date: October 2015
• Source: Ewha Womans University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

In this study, the recent trends in outcomes according to the dialysis modality in Korea since 2009, the effect of the use of peritoneal dialysis solutions containing icodextrin or high-glucose on various outcomes, the usefulness of 'PD first strategy', and the economic burden according to the dialysis modality will be investigated retrospectively using the Korean Health Insurance Review and Assessment Service (HIRA) database.

Description:

This study is designed as an observational and retrospective cohort study, thus there will be no intervention or specified prescription.

For the comparison of outcomes according to dialysis modality, we will adopt an intention-to-treat analysis, and consider the dialysis modality at day 90 to be the initial dialysis modality. However, the investigators will also regard the dialysis modality at day 30 as the initial dialysis modality in order to evaluate and compare earlier mortality.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30000
• Est. completion date: October 2018
• Est. primary completion date: October 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Patients who started dialysis during the study period and remained on the dialysis therapy for at least 90 days

Exclusion Criteria:

• Patients who were younger than 18 years of age

• Patients who survived for less than 90 days from the date of dialysis initiation

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Kidney Failure, Chronic
• Renal Insufficiency

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ewha Womans University

References & Publications (1)

Kim H, Kim KH, Park K, Kang SW, Yoo TH, Ahn SV, Ahn HS, Hann HJ, Lee S, Ryu JH, Kim SJ, Kang DH, Choi KB, Ryu DR. A population-based approach indicates an overall higher patient mortality with peritoneal dialysis compared to hemodialysis in Korea. Kidney Int. 2014 Nov;86(5):991-1000. doi: 10.1038/ki.2014.163. Epub 2014 May 7. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survival rate according to dialysis modality		up to 5 years	No