Ignite Creation Date:
2024-05-06 @ 7:30 PM
Last Modification Date:
2024-10-26 @ 3:08 PM
Study NCT ID:
NCT06032208
Status:
RECRUITING
Last Update Posted:
2024-05-29
First Post:
2023-08-31
Brief Title:
An Extension to Assess the Effect of Expanded Dialysis on Patient Reported Symptoms Using LEVIL
Sponsor:
Lawson Health Research Institute
Organization:
Lawson Health Research Institute
Study Overview
Official Title:
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
Status:
RECRUITING
Status Verified Date:
2024-05
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 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:
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
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
Study Oversight
Has Oversight DMC:
None
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?:
None
Is an FDA AA801 Violation?:
None