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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02573675
Recruitment Status : Unknown
Verified October 2015 by Ewha Womans University.
Recruitment status was:  Not yet recruiting
First Posted : October 12, 2015
Last Update Posted : October 12, 2015
Sponsor:
Information provided by (Responsible Party):
Ewha Womans University

Tracking Information
First Submitted Date October 8, 2015
First Posted Date October 12, 2015
Last Update Posted Date October 12, 2015
Study Start Date November 2015
Estimated Primary Completion Date October 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 8, 2015)
Survival rate according to dialysis modality [ Time Frame: up to 5 years ]
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title An Assessment on Current Outcomes of Peritoneal Dialysis in Korea
Official Title An Assessment on Current Outcomes of Peritoneal Dialysis in Korea
Brief 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.
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
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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
Condition Kidney Failure, Chronic
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: October 8, 2015)
30000
Original Estimated Enrollment Same as current
Estimated Study Completion Date October 2018
Estimated Primary Completion Date October 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT02573675
Other Study ID Numbers PDKOREA-1
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Ewha Womans University
Study Sponsor Ewha Womans University
Collaborators Not Provided
Investigators Not Provided
PRS Account Ewha Womans University
Verification Date October 2015