NCT Number: NCT06032208
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Seven Oaks Hospital Chronic Disease Innovation Centre Inc. (CDIC), Winnipeg, Manitoba, Canada
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:
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 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.
Time frame: Between weeks 1 & 4 and repeated during week 28
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:
Time frame: Between weeks 1 & 4 and repeated during week 28
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.
Time frame: Between weeks 1 & 4 and repeated during week 28
Parameters will be measured using Time-to-Recovery question at baseline (between weeks 1 & 4) and repeated at week 28.
Contact information is provided by the study sponsor or research team.
Christopher McIntyre, MBBS DM
CONTACT
5196858500 ext. 58502
Jarrin Penny, PHD RN CNeph
CONTACT
519-685-8500 ext. 58765
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Other
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)
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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