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

Comprehensive Prospective Study for Mode of Dialysis Therapy and Outcomes in ESRD

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.

Study Overview

• Status: Active, not recruiting
• Conditions: End-Stage Renal Disease

Detailed Description

The number of ESRD patients is growing at a much faster rate than the total population, with almost 1,000 (941.7) ESRD patients per one million as of 2006. The ESRD prevalence in Korea is ranked as high as 10th globally. The most common underlying diseases of ESRD in Korea include diabetes (42.3%), hypertension (16.9%), and chronic glomerulonephritis (13.0%). Diabetes and hypertension have been continuously increasing, as with a number of elderly patients due to population aging. From the examples of foreign countries with 2-to-3 fold larger dialysis population per million than Korea (ex. Japan, Taiwan, and the US), dialysis population here is forecasted to skyrocket. According to the 2003 data from the National Health Insurance Corporation that investigated diseases with high yearly treatment cost of over 5 million KRW, chronic renal failure (CRF) ranked first in both men and women. It was the single most expensive disease in 2000, with 212 billion KRW medical spending on 18,000 CRF patients, representing a significant burden to the national healthcare budget.

The ESRD Patient Registry run by the Korean Society of Nephrology (KSN) requires dialysis institutions to annually report the number of ESRD patients who receive renal replacement therapy, types of underlying disease, dialysis modality, and cause of death. Though the KSN statistics is useful as isolated epidemiological data, the program participation rate is only 60%, and cases of death are rarely reported. Clinical research on treatment or prognosis in CRF in Korea has mostly been performed by a single hospital or university, with no prospective, long-term, multi-center study performed yet.

The American Society of Nephrology, the National Kidney Foundation, and the American Association of Kidney Patients produce treatment guidelines based on effectiveness and safety proven through clinical trials. In the UK, NKRF and MRC have built databases on cardiovascular complications of chronic renal disease and outcomes with different treatment methods. Industrialized countries including the US, the UK, and Japan develop their standard treatment guidelines by thoroughly investigating etiology, progression, treatment, and cardiovascular complications and comparing effectiveness of known treatments.

The 5-year survival rate in ESRD patients in Korea is 37.8% for peritoneal dialysis patients and 65.2% for hemodialysis patients, respectively. There is a big discrepancy between patient's survival on HD and PD in Korea. However, it has been suspicious whether or not these survival data is convincing. QOL in maintenance dialysis patients is extremely low. Co-morbidity and time lost on dialysis makes it difficult to return to work while causing frequent hospitalization. Though their QOL might vary depending on country, culture, race, and dialysis modality, no multi-center study has been evaluated in Korea. CRF causes the largest per-patient health insurance reimbursement by the government, with the patient population continuously growing. Hospital stay is prolonged due to serious complications that require multi-disciplinary consultation drive up the medical cost. A cost-effectiveness study is urgently required. As in industrialized countries, the resources needed for development of the clinical practice guidelines are provided by the national government. "Effective clinical practice guidelines" will lower healthcare costs by preventing unnecessary medical practice and promote socioeconomic benefits and quality of care. The national government or related medical societies have yet to come up with a clinical practice guideline. Efforts should be made to work out "the KOREAN clinical practice guidelines" that will prevent clinical physicians from relying on foreign guidelines, which do not reflect the possibility of racial differences or was not proven to have effects on Koreans, and engaging in improper medical practices.

Our research contents are the same as below.

1. Basic data input by dialysis modality.
2. Collection of data on comorbidity and residual renal function at baseline.
3. Collection of data on referral time and history of emergent dialysis.
4. Comparative analysis of short-term QOL within 1 year of beginning dialysis.
5. Comparative analysis of complications by dialysis modality.
6. Comparative analysis of short-term patient/descriptive mortality and risk factors.
7. Creation of infection prevention and treatment guidelines in dialysis patients.
8. Comparative analysis of patient/descriptive mortality (3-year), complications, and risk factors by dialysis modality.
9. Analysis of cost-effectiveness by dialysis modality: survival rates and QOL versus cost.
10. Comparative analysis of residual renal function, its rate of decline, and survival rates by dialysis modality.

• Study Type: Observational
• Enrollment (Anticipated): 5400

Contacts and Locations

Study Locations

• Korea, Republic of
  • Busan, Korea, Republic of
    • Pusan National University Hospital
  • Busan, Korea, Republic of
    • Inje University Pusan Paik Hospital
  • Busan, Korea, Republic of
    • Dong-A University Medical Center
  • Busan, Korea, Republic of
    • Wallace Memorial Baptist Hospital
  • Cheongju, Korea, Republic of
    • Chungbuk National University Hospital
  • Daegu, Korea, Republic of, 41944
    • Kyungpook National University Hospital
  • Daegu, Korea, Republic of
    • Daegu fatima hospital
  • Daegu, Korea, Republic of
    • Yeungnam University Medical Center
  • Daejeon, Korea, Republic of
    • Chungnam National University Hospital
  • Daejeon, Korea, Republic of
    • Daejeon St. Mary's hospital
  • Goyang-si, Korea, Republic of
    • Holy Family Hospital
  • Goyang-si, Korea, Republic of
    • NHIC Ilsan Hospital
  • Gwangju, Korea, Republic of
    • Chonnam National University Hospital
  • Incheon, Korea, Republic of
    • Incheon St. Mary's Hospital
  • Jeju, Korea, Republic of
    • Cheju Halla General Hospital
  • Jeonju, Korea, Republic of
    • Chonbuk National University Hospital
  • Seongnam-si, Korea, Republic of
    • Seoul National University Bundang Hospital
  • Seoul, Korea, Republic of, 03080
    • Seoul National University Hospital
  • Seoul, Korea, Republic of
    • Asan Medical Center
  • Seoul, Korea, Republic of
    • Samsung Medical Center
  • Seoul, Korea, Republic of
    • Gangnam Severance Hospital
  • Seoul, Korea, Republic of, 03722
    • Severance Hospital
  • Seoul, Korea, Republic of
    • Seoul St. Mary's Hospital
  • Seoul, Korea, Republic of, 07061
    • Seoul National University Boramae Medical Center
  • Seoul, Korea, Republic of
    • Seoul Medical Center
  • Seoul, Korea, Republic of
    • St. Paul's Hospital
  • Seoul, Korea, Republic of, 04564
    • National Medical Center
  • Seoul, Korea, Republic of, 05029
    • Konkuk University
  • Seoul, Korea, Republic of, 07985
    • Ehwa Womans University Medical Center
  • Suwonsi, Korea, Republic of
    • St. Vincent's Hospital
  • Uijeongbu-si, Korea, Republic of
    • Uijeongbu St. Mary's Hospital
  • Ulsan, Korea, Republic of
    • Ulsan University Hospital
  • Wonju, Korea, Republic of
    • Wonju Christian Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Incident dialysis patients in Korea

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Dialysis modality; Hemodialysis, Peritoneal dialysis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	Scores (ESKD-specific domain, physical (PCS) and mental (MCS) component summary scores) in health related quality of life mearused by in health related quality of life mearused by the kidney disease quality of life (KDQOL)-Short Form (SF)-Each domain is rated on a scale from 0 to 100, with higher scores reflecting better HRQOL. The scores of the ESRD-targeted items are aggregated into KDCS score. The scores of the 36-Item Short Form Health Survey, a patient-reported survey of patient health, are classified into PCS score that includes items related to physical function, physical roles, pain, and general health, as well as MCS score that includes items related to emotional roles, emotional wellbeing, emotional energy, and social functioning.	One year
Incidence of depressive symptom measured by the Beck Depression Inventory-II (BDI-II) (range: 0-63, higher scores mean worse depressive symptoms)	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	Incidence of comorbidity measured by Charlson Comorbidity Index, Davies Comorbidity Index	One year
Rate of preserved residual renal function	Residual renal function-kt/v	Six months
Incidence of hospitalization episode and reason for hospitalization	Incidence of hospitalization episode and reason for hospitalization	Within the 4 weeks after the event
Incidence of infection episode	Incidence of infection episode	Within the 4 weeks after the event
Health cost	Health cost	One year

Collaborators and Investigators

• Sponsor: Clinical Research Center for End Stage Renal Disease, Korea
• Collaborators: Kyungpook National University Hospital; Medical Research Collaborating Center, Seoul, Korea; Ministry of Health & Welfare, Korea; National Clinical Research Coordination Center, Seoul, Korea; Daegu Metropolitan City, Korea
• Investigators: Principal Investigator: Yong-Lim Kim, M.D., Ph.D., Division of Nephrology and Department of Internal Medicine, Kyungpook National Univerisity Hospital, Daegu, Korea

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: July 1, 2009
• Primary Completion (Anticipated): December 1, 2023
• Study Completion (Anticipated): December 1, 2023

Study Registration Dates

• First Submitted: July 1, 2009
• First Submitted That Met QC Criteria: July 1, 2009
• First Posted (Estimate): July 2, 2009

Study Record Updates

• Last Update Posted (Actual): April 12, 2022
• Last Update Submitted That Met QC Criteria: April 7, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: Mortality; Hemodialysis; Peritoneal dialysis; Prospective cohort; Clinical study
• Additional Relevant MeSH Terms: Urologic Diseases; Renal Insufficiency; Renal Insufficiency, Chronic; Kidney Diseases; Kidney Failure, Chronic
• Other Study ID Numbers: A-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No