Clinical trial NCT00931970: Mode of Dialysis Therapy and Outcomes in End Stage Renal Disease (ESRD)
Official title: Comprehensive Prospective Study for Mode of Dialysis Therapy and Outcomes in ESRD
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: End-Stage Renal Disease
Keywords: Hemodialysis
Peritoneal dialysis
Mortality
Prospective cohort
Clinical study
Lead sponsor: Clinical Research Center for End Stage Renal Disease, Korea
Sponsor class: OTHER
Collaborators: name: Ministry of Health & Welfare, Korea
name: Kyungpook National University Hospital
name: Daegu Metropolitan City, Korea
name: National Clinical Research Coordination Center, Seoul, Korea
name: Medical Research Collaborating Center, Seoul, Korea
First posted: 2009-07-02
Enrollment: 5400
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Incident dialysis patients in Korea

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Incidence of all cause mortality
timeFrame: Within the 4 weeks after the event
measure: Incidence of change/termination of treatment modality
timeFrame: Within the 4 weeks after the event
Secondary outcomes:
measure: 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)
timeFrame: One year
measure: Incidence of depressive symptom measured by the Beck Depression Inventory-II (BDI-II) (range: 0-63, higher scores mean worse depressive symptoms)
timeFrame: One year
measure: Incidence of comorbidity measured by Charlson Comorbidity Index, Davies Comorbidity Index
timeFrame: One year
measure: Rate of preserved residual renal function
timeFrame: Six months
measure: Incidence of hospitalization episode and reason for hospitalization
timeFrame: Within the 4 weeks after the event
measure: Incidence of infection episode
timeFrame: Within the 4 weeks after the event
measure: Health cost
timeFrame: One year
Other outcomes:
Locations:
city: Busan
country: Korea, Republic of
facility: Dong-A University Medical Center
city: Busan
country: Korea, Republic of
facility: Inje University Pusan Paik Hospital
city: Busan
country: Korea, Republic of
facility: Pusan National University Hospital
city: Busan
country: Korea, Republic of
facility: Wallace Memorial Baptist Hospital
city: Cheongju
country: Korea, Republic of
facility: Chungbuk National University Hospital
city: Daegu
country: Korea, Republic of
facility: Kyungpook National University Hospital
city: Daegu
country: Korea, Republic of
facility: Daegu Fatima Hospital
city: Daegu
country: Korea, Republic of
facility: Yeungnam University Medical Center
city: Daejeon
country: Korea, Republic of
facility: Chungnam National University Hospital
city: Daejeon
country: Korea, Republic of
facility: Daejeon St. Mary's Hospital
city: Goyang-si
country: Korea, Republic of
facility: Holy Family Hospital
city: Goyang-si
country: Korea, Republic of
facility: NHIC Ilsan Hospital
city: Gwangju
country: Korea, Republic of
facility: Chonnam National University Hospital
city: Incheon
country: Korea, Republic of
facility: Incheon St. Mary's Hospital
city: Jeju
country: Korea, Republic of
facility: Cheju Halla General Hospital
city: Jeonju
country: Korea, Republic of
facility: Chonbuk National University Hospital
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Severance Hospital
city: Seoul
country: Korea, Republic of
facility: National Medical Center
city: Seoul
country: Korea, Republic of
facility: Konkuk University
city: Seoul
country: Korea, Republic of
facility: Seoul National University Boramae Medical Center
city: Seoul
country: Korea, Republic of
facility: Ehwa Womans University Medical Center
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Gangnam Severance Hospital
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: Seoul Medical Center
city: Seoul
country: Korea, Republic of
facility: Seoul St. Mary's Hospital
city: Seoul
country: Korea, Republic of
facility: St. Paul's Hospital
city: Suwonsi
country: Korea, Republic of
facility: St. Vincent's Hospital
city: Uijeongbu-si
country: Korea, Republic of
facility: Uijeongbu St. Mary's Hospital
city: Ulsan
country: Korea, Republic of
facility: Ulsan University Hospital
city: Wonju
country: Korea, Republic of
facility: Wonju Christian Hospital
Study officials:
affiliation: Division of Nephrology and Department of Internal Medicine, Kyungpook National Univerisity Hospital, Daegu, Korea
name: Yong-Lim Kim, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.