Ignite Creation Date:
2025-12-25 @ 12:14 AM
Ignite Modification Date:
2026-01-27 @ 9:20 AM
Study NCT ID:
NCT03640858
Status:
COMPLETED
Last Update Posted:
2024-12-24
First Post:
2018-08-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Expanded Dialysis on Patient Reported Symptoms Using LEVIL
Sponsor:
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Organization:
Study Overview
Official Title:
Interventional Study to Assess the Effect of Expanded Dialysis Using the Theranova Dialyzer on Patient Reported Symptoms Using the London Evaluation of Illness (LEVIL)
Status:
COMPLETED
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
Detailed Description:
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
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
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: