Kidney Failure, Chronic Clinical Trial
Official title:
Effects of Neutral pH and Low Glucose Degradation Product-containing Peritoneal Dialysis Fluid on Systemic Markers of Inflammation and Endothelial Dysfunction: a Randomized, Controlled 1-year Follow-up Study
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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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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