Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT00931970 |
| Other study ID # |
A-01 |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
July 2009 |
| Est. completion date |
December 2023 |
Study information
| Verified date |
April 2022 |
| Source |
Clinical Research Center for End Stage Renal Disease, Korea |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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.
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.
