The Comparison of Expanded Dialysis With Theranova Dialyzer With Conventional High-flux Hemodialysis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- lean tissue index
研究概览
简要总结
This research proposal of an investigator-initiated clinical study aims to examine the impact of uremic toxin removal afforded by middle cut-off (MCO) dialysis on clinical parameters and surrogate biomarkers pertinent to nutritional, systemic and vascular complications in dialysis patients. The primary research goal is to evaluate the outcomes indicative of nutritional status (as measured by body mass index, body composition monitoring, albumin, clinical assessments such as subjective global assessment, etc.) and parameters relevant to pathophysiological processes in uremia focusing on inflammation and cardiovascular risks. The secondary research aims are to examine dialysis efficacy between MCO dialysis and conventional hemodialysis (CHD). Specifically, dialysis efficacy will be determined by within and between subject differences in baseline versus short term (6 months) and long term (12 months) effects of MCO dialysis and CHD in:
- Removal of small molecules (e.g. urea), middle molecules (Beta-2 microglobulin, Phosphate and Creatinine) and protein bound solutes
- Markers of inflammation, ossification and fibrosis
- Uremia associated epigenetic modification The investigators hypothesize superiority of nutritional parameters in patients undergoing MCO dialysis compared with patients on CHD. The investigators plan to randomize 60 patients to either MCO dialysis or CHD at two hemodialysis units in Hong Kong.
详细描述
Accumulation of uremic toxins is associated morbidity and mortality in patients with end-stage renal disease, but the pathogenic mechanisms how they lead to various clinical complications remain elusive. Conventional hemodialysis is effective in removing small molecular solutes (in the range of 50-15,000 Da), but the removal of protein-bound and middle to larger molecular toxins (up to 50,000 Da) remains unsatisfactory even with augmented hemodialysis frequency or duration. The notion that dialysis adequacy is no longer a simple quantitative measure of small molecular removal has led to the clinical application of intensive hemodialysis and the search for novel strategies to reduce uremic toxin burden.
Recently, a new class of membrane with molecular weight cut off (MWCO) close to the molecular weight of albumin was introduced. The focus of this new therapy, known as expanded dialysis using the medium cut off (MCO) dialysis membrane, is to provide the potential for more efficient removal of middle molecules and protein bound uremic toxins without excessive loss of albumin. To date, MCO dialysis has been associated with a reduction in transcription of pro-inflammatory cytokines (i.e. interleukin 6 and tumor necrosis factor-α) and middle molecules especially free lambda light chains.
Protein-energy wasting and cardiovascular diseases are prevalent in chronic kidney disease and is related to inflammation and increased mortality. Despite growing data on the clearance of individual uremic toxins and biochemical parameters, the impact of MCO dialysis on clinical outcomes and mechanistic parameters related to nutrition and inflammation remains to be investigated.
The objective of the study is to compare MCO dialysis with conventional high-flux HD, on nutritional parameters, inflammation and cardiovascular biomarkers and related clinical outcomes.
Since twice-weekly HD is commonly practiced in Hong Kong, this study provides a distinct opportunity to investigate whether MCO dialysis might be particularly advantageous in patients receiving a relatively lower dialysis dose through the removal of a broader spectrum of uremic toxins.
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
- Single (Participant)
盲法说明
The dialyzer used will be covered
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •adult patients age greater than 18 years old
- •end-stage renal failure on two- or three-times per week high-flux HD for more than 90 days
- •mean spKt/Vurea >1.2 per session (for 3 dialysis sessions per week) or spKt/Vurea >1.8 per session (for 2 dialysis sessions per week)
排除标准
- •active malignancy
- •unable to give informed consent or complete questionnaires
- •unstable clinical condition defined as significant clinical event requiring hospitalization in the past 90 days
- •unreliable vascular access
- •unable to achieve HD blood flow >150ml/min
结局指标
主要结局
lean tissue index
时间窗: 12 months
measured by Body Composition Monitor
Body Mass Index
时间窗: 12 months
measured by weight (in kilograms) divided by the square of heights (in meters)
次要结局
- soluble thrombomodulin(12 months)
- fat tissue index(12 months)
- Klotho(12 months)
- hemoglobulin(12 months)
- Malnutrition-Inflammation Score(12 months)
- Subjective Global Assesment questionnaire(12 months)
- fibroblast growth factor 23(12 months)
- Kt/V urea(12 months)
- tumor necrosis factor alpha(12 months)
- admission rate due to cardiovascular events(12 months)
- interleukin 6(12 months)
- albumin(12 months)
- phosphate(12 months)
- high-density lipoprotein(12 months)
- triglyceride(12 months)
- soluble endothelial protein C receptor(12 months)
- beta-2 microglobulin(12 months)
- Pentraxin-3(12 months)
- high-sensitive C reactive protein(12 months)
- Leptin(12 months)
- admission rate due to infection(12 months)
- 5-D itch scale(12 months)
- Numeric rating scale for itchiness(12 months)
- asymmetrical dimethylarginine(12 months)
- adiponectin(12 months)
- low-density lipoprotein(12 months)
- mortality rate(12 months)
- Visual analogue scale for appetite(12 months)
- DNA methylation analysis of LY96 gene(12 months)
- DNA methylation analysis of IFNGR1 gene(12 months)
- Hong Kong Montreal Cognitive Assessment(12 months)
- Postdialysis recovery time(12 months)
- Self-reported sleep quality(12 months)
- KDQOLSFTMv1.3 questionnaire(12 months)
- DNA methylation analysis of TRPV1 gene(12 months)
- The Functional Assessment of Anorexia/Cachexia Therapy (FAACT) score(12 months)
研究者
Dr. Mok Ming Yee
Principal investigator
The University of Hong Kong