Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
100

Summary

Conditions
End Stage Renal Disease
Type
Interventional
Phase
Not Applicable
Design
Allocation: N/AIntervention Model: Single Group AssignmentIntervention Model Description: Study visits take place within the patients' usual hemodialysis unit consistent with their routinely scheduled dialysis sessions. Beginning week 3 and 23 participants use the Theranova dialyzer until the end of the dialysis week on week 14 and 46. Participants answer 9 questions with at least one session regarding symptoms experienced since their last session using the LEVIL application. Furthermore, participants answer a single time to recovery question at the first treatment of weeks 1, 14, 22, and 46 to get more detailed information on recovery time after dialysis in addition to completing the 5-D Pruritus and the Restless Legs Syndrome scales. Bloodwork is drawn at 3intervals throughout the study for laboratory evaluation. Participants have an echo at baseline and once between weeks 10 to 14 while on the Theranova dialyzer. In addition to this, participants will have non-invasive monitoring of circulatory stress using the CVInsight contact device at the same time intervals.Masking: None (Open Label)Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

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 e...

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 54 weeks in length: LEVIL entries with at least one hemodialysis treatment each week for 54 weeks Blood sampling at 2 time points for all participants and at 3 time points for LHSC participants only Implementation of Theranova dialyzer from weeks 3 through 14 and weeks 23 through 46 Wash out period from weeks 15 through 22 and weeks 47 through 54 Time to recovery question at the first treatment of weeks 1, 14, 22, and 46 for new participants 5-D Pruritus scale and Restless Legs Syndrome rating scale at the first treatment of weeks 1, 14, 22, and 46 Echocardiogram prior to starting hemodialysis and at peak stress at baseline (within the first two weeks), with one treatment between weeks 10 to 14 which will occur mid-week, and with one treatment between weeks 42 to 46 which will occur mid-week (LHSC specific) CVInsight monitoring at baseline (within the first two weeks), with one treatment between weeks 10 to 14, and with one treatment between weeks 42 to 46 (LHSC specific)

Tracking Information

NCT #
NCT03640858
Collaborators
Baxter Healthcare Corporation
Investigators
Principal Investigator: Christopher McIntyre, MBBS DM London Health Sciences Centre