Mode of Dialysis Therapy and Outcomes in End Stage Renal Disease (ESRD)

NCT00931970 | Unknown DMC

• 1 other identifier: A-01
• Study Type: observational
• Target: 5,400
• Locations: 1 country
• Sites: 33

Brief Summary

The purpose of this study is: 1\. to compare complications and mortality of hemodialysis with those of peritoneal dialysis in Korean end stage renal disease (ESRD) patients; 2. to analyze the treatment effects on quality of life (QOL) by dialysis modality; and 3. to analyze cost-effectiveness by dialysis modality.

Conditions

End-Stage Renal Disease

Keywords

Hemodialysis; Peritoneal dialysis; Mortality; Prospective cohort; Clinical study

Outcome Measures

Primary Outcomes (2)

• Incidence of all cause mortality

  Survival

  Within the 4 weeks after the event

• Incidence of change/termination of treatment modality

  Incidence of change/termination dialysis modality

  Within the 4 weeks after the event

Secondary Outcomes (7)

• Scores (ESKD-specific domain, physical (PCS) and mental (MCS) component summary scores) in health related quality of life mearused by the kidney disease quality of life (KDQOL)-Short Form (SF)

  One year

• Incidence of depressive symptom measured by the Beck Depression Inventory-II (BDI-II) (range: 0-63, higher scores mean worse depressive symptoms)

  One year

• Incidence of comorbidity measured by Charlson Comorbidity Index, Davies Comorbidity Index

  One year

• Rate of preserved residual renal function

  Six months

• Incidence of hospitalization episode and reason for hospitalization

  Within the 4 weeks after the event

Study Arms (1)

Dialysis modality

Hemodialysis, Peritoneal dialysis

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Incident dialysis patients in Korea

You may qualify if:

• Clinical diagnosis of end stage renal disease
• Must be at least 20 years of age
• Dialysis must be initiated in Korea
• Informed consent

You may not qualify if:

• Scheduled to receive kidney transplantation within 3 months
• Scheduled to emigrate to foreign country within 3 months
• Clinically suspected as acute renal failure

Sponsors & Collaborators

• Clinical Research Center for End Stage Renal Disease, Korea: lead
• Ministry of Health & Welfare, Korea: collaborator
• Kyungpook National University Hospital: collaborator
• Daegu Metropolitan City, Korea: collaborator
• National Clinical Research Coordination Center, Seoul, Korea: collaborator
• Medical Research Collaborating Center, Seoul, Korea: collaborator

Study Sites (33)

Dong-A University Medical Center

Busan, South Korea

Location

Inje University Pusan Paik Hospital

Busan, South Korea

Location

Pusan National University Hospital

Busan, South Korea

Location

Wallace Memorial Baptist Hospital

Busan, South Korea

Location

Chungbuk National University Hospital

Cheongju-si, South Korea

Location

Kyungpook National University Hospital

Daegu, 41944, South Korea

Location

Daegu Fatima Hospital

Daegu, South Korea

Location

Yeungnam University Medical Center

Daegu, South Korea

Location

Chungnam National University Hospital

Daejeon, South Korea

Location

Daejeon St. Mary's Hospital

Daejeon, South Korea

Location

Holy Family Hospital

Goyang-si, South Korea

Location

NHIC Ilsan Hospital

Goyang-si, South Korea

Location

Chonnam National University Hospital

Gwangju, South Korea

Location

Incheon St. Mary's Hospital

Incheon, South Korea

Location

Cheju Halla General Hospital

Jeju City, South Korea

Location

Chonbuk National University Hospital

Jeonju, South Korea

Location

Seoul National University Bundang Hospital

Seongnam-si, South Korea

Location

Seoul National University Hospital

Seoul, 03080, South Korea

Location

Severance Hospital

Seoul, 03722, South Korea

Location

National Medical Center

Seoul, 04564, South Korea

Location

Konkuk University

Seoul, 05029, South Korea

Location

Seoul National University Boramae Medical Center

Seoul, 07061, South Korea

Location

Ehwa Womans University Medical Center

Seoul, 07985, South Korea

Location

Asan Medical Center

Seoul, South Korea

Location

Gangnam Severance Hospital

Seoul, South Korea

Location

Samsung Medical Center

Seoul, South Korea

Location

Seoul Medical Center

Seoul, South Korea

Location

Seoul St. Mary's Hospital

Seoul, South Korea

Location

St. Paul's Hospital

Seoul, South Korea

Location

St. Vincent's Hospital

Suwon, South Korea

Location

Uijeongbu St. Mary's Hospital

Uijeongbu-si, South Korea

Location

Ulsan University Hospital

Ulsan, South Korea

Location

Wonju Christian Hospital

Wŏnju, South Korea

Location

Related Publications (4)

• Ethier I, Hayat A, Pei J, Hawley CM, Johnson DW, Francis RS, Wong G, Craig JC, Viecelli AK, Htay H, Ng S, Leibowitz S, Cho Y. Peritoneal dialysis versus haemodialysis for people commencing dialysis. Cochrane Database Syst Rev. 2024 Jun 20;6(6):CD013800. doi: 10.1002/14651858.CD013800.pub2.

  PMID: 38899545 DERIVED

• Jung HY, Jeon Y, Kim YS, Kang SW, Yang CW, Kim NH, Noh HW, Jeon SJ, Lim JH, Choi JY, Cho JH, Park SH, Kim CD, Kim YL. Sex disparities in mortality among patients with kidney failure receiving dialysis. Sci Rep. 2022 Nov 3;12(1):18555. doi: 10.1038/s41598-022-16163-w.

  PMID: 36329070 DERIVED

• Oh HJ, Lee MJ, Lee HS, Park JT, Han SH, Yoo TH, Kim YL, Kim YS, Yang CW, Kim NH, Kang SW. NT-proBNP: is it a more significant risk factor for mortality than troponin T in incident hemodialysis patients? Medicine (Baltimore). 2014 Dec;93(27):e241. doi: 10.1097/MD.0000000000000241.

  PMID: 25501091 DERIVED

• Choi JY, Jang HM, Park J, Kim YS, Kang SW, Yang CW, Kim NH, Cho JH, Park SH, Kim CD, Kim YL; Clinical Research Center for End Stage Renal Disease (CRC for ESRD) Investigators. Survival advantage of peritoneal dialysis relative to hemodialysis in the early period of incident dialysis patients: a nationwide prospective propensity-matched study in Korea. PLoS One. 2013 Dec 30;8(12):e84257. doi: 10.1371/journal.pone.0084257. eCollection 2013.

  PMID: 24386357 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Serum Whole blood Urine Dialysate

MeSH Terms

Conditions

Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Yong-Lim Kim, M.D., Ph.D.

  Division of Nephrology and Department of Internal Medicine, Kyungpook National Univerisity Hospital, Daegu, Korea

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 1, 2009
• First Posted: July 2, 2009
• Study Start: July 1, 2009
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: April 12, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

KR (33)