Effect of Expanded Dialysis on Patient Reported Symptoms Using LEVIL

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Status

Completed

Conditions

End Stage Renal Disease

Treatments

Device: Theranova Dialyzer

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT03640858

1589

Details and patient eligibility

About

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.

Full 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

Enrollment

82 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Chronic hemodialysis patient
Must be on hemodialysis for at least 3 months
Age ≥18 years
Willing and able to give informed consent

Exclusion criteria

Active infection
Active cancer
Life expectancy <1 year as estimated by care provider
Hemodialysis patients currently receiving Hemodiafiltration (HDF), Hemofiltration (HF) or Isolated ultrafiltration (ISO UF)