Interventional Study to Assess the Effect of Expanded Dialysis Using the Theranova Dialyzer on Patient Reported Symptoms Using the London Evaluation of Illness (LEVIL)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 82
- 试验地点
- 4
- 主要终点
- A change in larger middle molecule induced symptoms as assessed by the LEVIL application
研究概览
简要总结
Investigators know that many patients who are on dialysis suffer from the burden of unwanted symptoms, which can affect quality of life. In this study, the investigators will be assessing symptom burden using the London Evaluation of Illness "LEVIL," an application based platform where patients self-report their symptoms with at least one hemodialysis treatment. The investigators would like to compare the currently available dialyzer with a new dialyzer that is capable of removing solutes of higher molecular weight that may or may not cause patients to experience symptoms related to increased amounts of these toxins in their blood.
详细描述
Baxter Canada has an expanded hemodialysis (HDx) membrane called the "Theranova", which is capable of removing solutes of higher molecular weight. Although this clearly has biochemical advantages it is not known at this time if the removal of larger middle molecules can have a direct and immediate effect on patients reported symptoms and quality of life. In short, do be people actually feel better?
Given the way many QoL measurements fluctuate around the dialysis week, the investigators propose to utilize a dynamic tool. The investigators will be assessing symptom burden using the London Evaluation of Illness "LEVIL" an application based platform where patients self-report their symptoms with at least one hemodialysis treatment. Reports are generated immediately and in real-time, which cannot be accomplished with other symptom management tools. This allows the investigators to track study changes and benchmark observations to previously established baseline values. The investigators are excited to see if there is an imminent effect on how patients feel using the Theranova dialyzer.
The study is investigator initiated and the principal investigator has secured modest funding from Baxter to allow support for the core study team and the introduction and maintenance of the LEVIL evaluation platform at other centers. Baxter have also provided some dialyzer support, and will work with individual centers to ensure that there is no consumable increment of cost associated with participation.
The study is 60 weeks in length:
- LEVIL entries with at least one hemodialysis treatment each week for 60 weeks
- Blood sampling at 4 time points for all participants
- Implementation of Theranova dialyzer from weeks 5 through 16 and weeks 25 through 48
- Wash out period from weeks 17 through 24 and weeks 49 through 60
- Time to recovery question at the first treatment of weeks 1, 16, 24, and 48 for new participants
- 5-D Pruritus scale and Restless Legs Syndrome rating scale at the first treatment of weeks 1, 16, 24, and 48
- Echocardiogram prior to starting hemodialysis and at peak stress at baseline (within the first two weeks), with one treatment between weeks 12 to 16 which will occur mid-week, and with one treatment between weeks 44 to 48 which will occur mid-week (LHSC specific)
- CVInsight monitoring at baseline (within the first two weeks), with one treatment between weeks 2 to 16, 20 to 25, and with one treatment between weeks 44 to 48 (LHSC specific)
- Non-invasive assessment of cardiovascular risk using the AGE Reader within 1 hour of starting hemodialysis at baseline, with one treatment between weeks 12 to 16, 20 to 24, and with one treatment between weeks 44 to 48 which will occur mid-week (LHSC specific)
- Five Time Sit to Stand Test & 60-Second Chair Test at the second treatment of weeks 1, 16, 24, and 48
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Chronic hemodialysis patient
- •Must be on hemodialysis for at least 3 months
- •Age ≥18 years
- •Willing and able to give informed consent
排除标准
- •Active infection
- •Active cancer
- •Life expectancy <1 year as estimated by care provider
- •Hemodialysis patients currently receiving Hemodiafiltration (HDF), Hemofiltration (HF) or Isolated ultrafiltration (ISO UF)
结局指标
主要结局
A change in larger middle molecule induced symptoms as assessed by the LEVIL application
时间窗: Beginning week 1 and ending at the end of the dialysis week on week 46
The primary outcome will be a change (from patient's own baseline) in general well-being, pain, sleep, breathing, energy, appetite, itch, restless legs, and recovery from hemodialysis when using the Theranova dialyzer. These parameters will be measured using the LEVIL an electronic application based visual analog scale.
次要结局
- Correlation between large middle molecules and patient symptoms(Beginning week 1 and ending at the end of the dialysis week on week 54)
- A change in symptoms with a change in dialyzer (usual to Theranova and vice versa)(Beginning week 1 and ending at the end of the dialysis week on week 54)
- Effect on microcirculation and/or hemodialysis induced circulatory stress with the Theranova dialyzer(Beginning week 3 and ending at the end of the dialysis week on week 14 and again week 23 and ending week 46)
- A change in larger middle molecule clearance using the Theranova dialyzer(First treatment of weeks 1, 14, and 46)
研究者
Chris McIntyre
Professor of Medicine, Medical Biophysics and Paediatrics, Robert Lindsay Chair of Dialysis Research and Innovation
London Health Sciences Centre