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| ID | Type | Description | Link |
|---|---|---|---|
| A084001 | Other Grant/Funding Number | Ministry for Health and Welfare, Republic of Korea (A084001) |
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| Name | Class |
|---|---|
| Ministry of Health & Welfare, Korea | OTHER_GOV |
| Fresenius Medical Care Korea | INDUSTRY |
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The purpose of this study is to evaluate the effects of neutral pH and low glucose degradation product (GDP)-containing peritoneal dialysis fluid (PDF) on systemic inflammation and endothelial dysfunction markers in incident PD patients.
New peritoneal dialysis fluids (PDF) with neutral pH and low glucose degradation products (GDPs) are used in patients on peritoneal dialysis (PD). Low GDP fluids are reported to be more biocompatible than conventional PDF. Determination of biocompatibility has mainly focused on local peritoneal effects; recently, there has been interest in evaluating the systemic biocompatibility of these fluids.
In recent analyses of two retrospective cohorts of Korean PD patients, significant survival advantage was shown for patients treated with the biocompatible PDF compared to patients treated with conventional PDF. However, the mechanisms of survival advantage with low GPD PDF in these observational studies are difficult to assess. Additionally, it is not clear that new PDFs favorably impact risk markers of cardiovascular disease (CVD).
Epidemiologic studies identified an independent association between inflammation and risk of cardiovascular events and mortality; this association has been confirmed in patients with advanced chronic kidney diseases (CKD).Other evidence showed that clinically overt vascular events are preceded by endothelial dysfunction and increases in circulating markers of endothelial activation, including vascular cellular adhesion molecule (VCAM)-1 and intercellular adhesion molecule (ICAM)-1.Moreover, there is an association between inflammation and elevated levels of soluble VCAM-1 and ICAM-1 in patients with or at risk of atherosclerosis. Elevated levels of soluble adhesion molecules are found in ESRD patients, especially in patients with CVD and malnutrition.
The investigators hypothesized that conventional PDF as well as uremia itself lead to local peritoneal changes such as peritoneal neoangiogenesis and fibrosis, effects related to ultrafiltration failure and subsequently volume overload. In addition, direct effect of GDPs and/or increased systemic levels of AGEs activate endothelial cells and increase levels of vascular adhesion molecules and inflammation. Both local and systemic effects of PDF are possibly associated with increased cardiovascular risks and mortality in PD patients.
This study aims to examine the effects of neutral pH and low GDP-containing PDF on systemic inflammation and endothelial dysfunction in incident PD patients in a randomized, controlled study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| conventional PDF (Stay safe) | No Intervention | ||
| low GDP PDF (Balance) | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Balance, Fresenius Medical Care, Germany | Drug | low glucose degradation product (GDP)-containing peritoneal dialysis fluid (PDF) |
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| Measure | Description | Time Frame |
|---|---|---|
| Inflammation-endothelial-dysfunction index (IEDI) | Inflammation-endothelial-dysfunction index (IEDI) is a composite score derived from measurement of serum levels of CRP (high sensitivity assay), soluble VCAM-1 and soluble ICAM-1. Changes between the groups will be tested by analysis of covariance (ANCOVA) with baseline values as covariates. Serial data will also be analyzed using a linear mixed model. | Baseline and 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Individual component markers of IEDI | individual component markers of the IEDI including sICAM-1, sVCAM-1, and hs-CRP | Baseline and 12 months |
| RRF | residual renal function (RRF) as average of urea and creatinine clearances by 24 hour urine collection |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yong-Lim Kim, Professor | Kyungpook National University Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Division of Nephrology and Department of Internal Medicine, Kyungpook National University Hospital | Daegu | 700-721 | South Korea |
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| ID | Term |
|---|---|
| D007676 | Kidney Failure, Chronic |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
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| Baseline and 12 months |
| peritoneal clearance | peritoneal clearance as weekly Kt/V urea and creatinine clearance | Baseline and 12 months |
| peritoneal ultrafiltration | peritoneal ultrafiltration volume | Baseline and 12 months |
| peritoneal transport status | dialysate-to-plasma ratio of creatinine at 4 hours of peritoneal equilibration test | Baseline and 12 months |
| serum albumin | Baseline and 12 months |
| LBM | lean body mass (LBM) estimated from creatinine kinetics | Baseline and 12 months |
| nPNA | normalized protein equivalent of nitrogen appearance (nPNA) | Baseline and 12 months |
| SGA | subjective global assessment (SGA) with a four item and seven-point scale | Baseline and 12 months |
| Blood pressure | systolic and diastolic blood pressure | Baseline and 12 months |
| use of antihypertensive medications | number of antihypertensive medications | Baseline and 12 months |
| peritonitis rates | peritonitis rates | 12 months |
| technique survival | technique survival by Kaplan-Meier survival analysis with Log-Rank test. | 12months |
| patient survival | patient survival by Kaplan-Meier survival analysis with Log-Rank test. | 12 months |
| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |