Effect of Expanded Dialysis on Patient Reported Symptoms Using LEVIL

NCT ID: NCT03640858

Last Updated: 2024-12-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 82 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-05-08
• Study Completion Date: 2023-04-30

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

Conditions

End Stage Renal Disease

Keywords

Hemodialysis; Larger middle molecules; Theranova

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Patients receiving hemodialysis

A group of hemodialysis patients will be receiving the Theranova dialyzer during their regularly scheduled sessions to remove larger middle molecules

Group Type: EXPERIMENTAL

Theranova Dialyzer

Intervention Type: DEVICE

The Theranova dialyzer will be used for each of the hemodialysis treatments beginning week 3 and ending at the end of the dialysis week on week 14 and again starting week 23 and ending at the end of the dialysis week on week 46 . This will allow us to compare patient reported symptoms in weeks 1 and 2 when patients are on their usual dialyzer with their symptoms using the Theranova dialyzer. This will also allow us to see if there is a carry-over effect.

Interventions

Theranova Dialyzer

The Theranova dialyzer will be used for each of the hemodialysis treatments beginning week 3 and ending at the end of the dialysis week on week 14 and again starting week 23 and ending at the end of the dialysis week on week 46 . This will allow us to compare patient reported symptoms in weeks 1 and 2 when patients are on their usual dialyzer with their symptoms using the Theranova dialyzer. This will also allow us to see if there is a carry-over effect.

Intervention Type: DEVICE

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Baxter Healthcare Corporation

INDUSTRY

Sponsor Role: collaborator

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

OTHER

Sponsor Role: lead

Responsible Party

Chris McIntyre

Professor of Medicine, Medical Biophysics and Paediatrics, Robert Lindsay Chair of Dialysis Research and Innovation

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Christopher McIntyre, MBBS DM

Role: PRINCIPAL_INVESTIGATOR

London Health Sciences Centre

Locations

Adam Linton Dialysis Unit

London, Ontario, Canada

Kidney Care Centre

London, Ontario, Canada

Countries

Canada

References

Penny JD, Jarosz P, Salerno FR, Lemoine S, McIntyre CW. Impact of Expanded Hemodialysis Using Medium Cut-off Dialyzer on Quality of Life: Application of Dynamic Patient-Reported Outcome Measurement Tool. Kidney Med. 2021 Jul 29;3(6):992-1002.e1. doi: 10.1016/j.xkme.2021.05.010. eCollection 2021 Nov-Dec.

Reference Type: DERIVED

PMID: 34939008 (View on PubMed)

Other Identifiers

1589

Identifier Type: -

Identifier Source: org_study_id