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
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 146
- 试验地点
- 1
- 主要终点
- Inflammation-endothelial-dysfunction index (IEDI)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female patients aged over 18 years and less than 75 years
- •Within 90 days of initiation of first renal replacement treatment for ESRD
- •Selected for maintenance management by CAPD
- •Having provided informed consent
- •Physically and mentally capable of performing the therapy
排除标准
- •Patients were excluded if deemed to have less than 80% likelihood of survival for at least 1 year
- •episodes of peritonitis within prior 30 days
- •any malignancy other than treated skin carcinoma
- •uncontrolled congestive heart failure
- •recent (within 60 days) myocardial infarction or cerebrovascular accident
- •active systemic vasculitic disease including systemic lupus erythematosus, polyarteritis nodosa, ANCA-nephritis, active rheumatoid disease, or active venous thrombotic-embolic disease
- •any acute infection at the time of enrollment
- •active or actively treated tuberculosis
- •recent (within 30 days) systemic bacterial infection.
研究组 & 干预措施
low GDP PDF (Balance)
干预措施: Balance, Fresenius Medical Care, Germany (Drug)
结局指标
主要结局
Inflammation-endothelial-dysfunction index (IEDI)
时间窗: Baseline and 12 months
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.
次要结局
- Individual component markers of IEDI(Baseline and 12 months)
- RRF(Baseline and 12 months)
- peritoneal clearance(Baseline and 12 months)
- peritoneal ultrafiltration(Baseline and 12 months)
- peritoneal transport status(Baseline and 12 months)
- serum albumin(Baseline and 12 months)
- LBM(Baseline and 12 months)
- nPNA(Baseline and 12 months)
- SGA(Baseline and 12 months)
- Blood pressure(Baseline and 12 months)
- use of antihypertensive medications(Baseline and 12 months)
- peritonitis rates(12 months)
- technique survival(12months)
- patient survival(12 months)