An Extension to Assess the Effect of Expanded Dialysis on Patient Reported Symptoms Using LEVIL

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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)

Conditions
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End Stage Renal Disease

Intervention / Treatment
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* Device: Theranova Dialyzer


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Conventional thrice weekly HD schedule Must be on hemodialysis for at least 3 months Age ≥18 years Willing and able to give informed consent Exclusion Criteria: Active infection (may enroll once infection is cleared) 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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Study visits take place within the patients usual hemodialysis unit consistent with their routinely scheduled dialysis sessions. Beginning week 5 participants will use the Theranova dialyzer until the end of dialysis week 28. Participants will answer 9 questions at least (1-3 times weekly) - weeks 1 through 28 (entire length of study) using the LEVIL application. Furthermore, participants answer a single Time-to-Recovery question between weeks 1-4 and repeated at week 28 to get more information on recovery time after dialysis in addition to completing Creyos (cognitive testing formally Cambridge Brain Sciences), as well as Sexual Desire Inventory-2 testing.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patients receiving Hemodialysis<br>A group of hemodialysis patients will be receiving the Theranova dialyzer during their regular scheduled dialysis sessions to remove larger middle molecules. | Device: Theranova Dialyzer<br>* The Theranova dialyzer will be used for each of the hemodialysis treatments beginning week 5 and ending at the end of dialysis week 28. This will allow us to compare patient reported symptoms in weeks 1-4 on their usual dialyzer with with their symptoms on the Theranova dialyzer.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | Beginning week 1 and ending at the end of dialysis on week 28. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine if the clearance of larger middle molecular weight toxins using medium-cut-off dialyzer (HDx-Theranova) effects cognition. | Cognitive Testing measured using Creyos (formally Cambridge Brain Sciences) web-based application at baseline (between weeks 1 & 4) and repeated at week 28. Creyos consists of tasks that are separated into domains of reasoning, short term memory, and verbal abilities: 1. Odd one Out (patterns), 2. Digit Span (number sequence), 3. Paired Association Task, 5. Rotations Task, 6. Monkey Ladder Task | 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 sexual desire | Parameters will be measured using Sexual Desires Inventory-2 (SDI-2) an anonymous web-based platform at baseline (between weeks 1 & 4) and repeated at week 28. SDI-2 is a multiple choice platform where participants will privately answer questions that best describes how they feel. (eg. not at all, once a month, once every two months, once a week, twice a week, 3 to 4 times a week, once a day, more then once a day) A score will be populated within the app and the score will be recorded only. | 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. | Parameters will be measured using Time-to-Recovery question at baseline (between weeks 1 & 4) and repeated at week 28. | Between weeks 1 & 4 and repeated during week 28 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hemodialysis, Large middle molecules, Theranova