An Extension of an Interventional Study to Assess the Effect of Expanded Dialysis (HDx-Theranova) on Patient Reported Symptoms Using London Evaluation of Illness (LEVIL)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 6
- 主要终点
- Determine if the clearance of larger middle molecular weight toxins using medium-cut-off dialyzer (HDx -Theranova) effects patient reported symptoms as determined by LEVIL.
研究概览
简要总结
Investigators know that many patients who are on dialysis suffer from burden of unwanted symptoms, which can affect quality of life. The understanding and treatment of symptom burden by healthcare providers is limited and should be recognized as a high priority in the care of the dialysis population. 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 one to three hemodialysis treatments per week for 28 weeks. 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 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 people actually feel better?
Given the way many quality of life 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 28 weeks in length:
- LEVIL entries with at least 1 to 3 hemodialysis treatments each week for 28 weeks.
- Implementation of Theranova dialyzer from week 5 until the end of week 28.
- Creyos (cognitive testing) one time at baseline (between weeks 1 to 4) and again during week 28.
- Sexual Desire questionnaire one time at baseline (between weeks 1 to 4) and again during week 28.
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
- •Conventional thrice weekly HD schedule
- •Must be on chronic hemodialysis for at least 3 months
- •Age ≥18 years
- •Willing and able to give informed consent
排除标准
- •Active infection (may enroll once infection is cleared)
- •Patients receiving daily hemodialysis treatment
- •Patients currently receiving Hemodiafiltration (HDF), Hemofiltration (HF) or Isolated ultrafiltration (ISO UF) more than once in three months
- •Visual impairment
- •History of neurocognitive impairment
- •History of stroke (CVA)
研究组 & 干预措施
Patients receiving Hemodialysis
A group of hemodialysis patients will be receiving the Theranova dialyzer during their regular scheduled dialysis sessions to remove larger middle molecules.
干预措施: Theranova Dialyzer (Device)
结局指标
主要结局
Determine if the clearance of larger middle molecular weight toxins using medium-cut-off dialyzer (HDx -Theranova) effects patient reported symptoms as determined by LEVIL.
时间窗: Beginning week 1 and ending at the end of dialysis on week 28.
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. The scale indicates Very Poor on the left and Excellent to the right or Extreme on the left to No Problem on the right. Participants will use their finger and slide the scale to indicate which best describes how they feel.
次要结局
- Determine if the clearance of larger middle molecular weight toxins using medium-cut-off dialyzer (HDx-Theranova) effects sexual desire(Between weeks 1 & 4 and repeated during week 28)
- Determine if the clearance of larger middle molecular weight toxins using medium-cut-off dialyzer (HDx-Theranova) effects dialysis recovery time compared to high-flux dialysis membrane.(Between weeks 1 & 4 and repeated during week 28)
- Determine if the clearance of larger middle molecular weight toxins using medium-cut-off dialyzer (HDx-Theranova) effects cognition.(Between weeks 1 & 4 and repeated during week 28)
研究者
Chris McIntyre
Professor of Medicine, Medical Biophysics and Paediatrics, Robert Lindsay Chair of Dialysis Research and Innovation
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's