An Assessment on Current Outcomes of Peritoneal Dialysis in Korea (PDKOREA)

October 8, 2015 updated by: Ewha Womans University
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.

Study Overview

Status

Unknown

Conditions

Detailed 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.

Study Type

Observational

Enrollment (Anticipated)

30000

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All incident dialysis patients who started chronic dialysis therapy between January 1, 2009 and December 31, 2014 in Korea

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Survival rate according to dialysis modality
Time Frame: up to 5 years
up to 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ewha Womans University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2015

Primary Completion (Anticipated)

October 1, 2018

Study Completion (Anticipated)

October 1, 2018

Study Registration Dates

First Submitted

October 8, 2015

First Submitted That Met QC Criteria

October 8, 2015

First Posted (Estimate)

October 12, 2015

Study Record Updates

Last Update Posted (Estimate)

October 12, 2015

Last Update Submitted That Met QC Criteria

October 8, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PDKOREA-1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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