Effect of Expanded Dialysis on Patient Reported Symptoms Using LEVIL

NCT03640858 | Completed

• 1 other identifier: 1589
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 2

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.

Conditions

End Stage Renal Disease

Keywords

Hemodialysis; Larger middle molecules; Theranova

Outcome Measures

Primary Outcomes (1)

• A change in larger middle molecule induced symptoms as assessed by the LEVIL application

  The primary outcome will be a change (from patient's own baseline) in general well-being, pain, sleep, breathing, energy, appetite, itch, restless legs, and recovery from hemodialysis when using the Theranova dialyzer. These parameters will be measured using the LEVIL an electronic application based visual analog scale.

  Beginning week 1 and ending at the end of the dialysis week on week 46

Secondary Outcomes (4)

• A change in larger middle molecule clearance using the Theranova dialyzer

  First treatment of weeks 1, 14, and 46

• Correlation between large middle molecules and patient symptoms

  Beginning week 1 and ending at the end of the dialysis week on week 54

• A change in symptoms with a change in dialyzer (usual to Theranova and vice versa)

  Beginning week 1 and ending at the end of the dialysis week on week 54

• Effect on microcirculation and/or hemodialysis induced circulatory stress with the Theranova dialyzer

  Beginning week 3 and ending at the end of the dialysis week on week 14 and again week 23 and ending week 46

Study Arms (1)

Patients receiving hemodialysis

EXPERIMENTAL

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

Device: Theranova Dialyzer

Interventions

Theranova Dialyzer 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.

Patients receiving hemodialysis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: lead
• Baxter Healthcare Corporation: collaborator

Study Sites (2)

Adam Linton Dialysis Unit

London, Ontario, N6A 5W9, Canada

Location

Kidney Care Centre

London, Ontario, N6K 1M6, Canada

Location

Related Publications (1)

• 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.

  PMID: 34939008 DERIVED

MeSH Terms

Conditions

Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Christopher McIntyre, MBBS DM

  London Health Sciences Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine, Medical Biophysics and Paediatrics, Robert Lindsay Chair of Dialysis Research and Innovation

Model Details: Study visits take place within the patients' usual hemodialysis unit consistent with their routinely scheduled dialysis sessions. Beginning week 5 and 25 participants use the Theranova dialyzer until the end of the dialysis week on week 16 and 48. Participants answer 9 questions at least at 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, 16, 24, and 48 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 4 intervals throughout the study for laboratory evaluation. Participants have an echo at baseline and between weeks 12 to 16, 20-24 and 44-48 while on the Theranova dialyzer. In addition to this, participants will have non-invasive monitoring of circulatory stress using the CVInsight contact device.

Study Record Dates

• First Submitted: August 14, 2018
• First Posted: August 21, 2018
• Study Start: May 8, 2019
• Primary Completion: April 30, 2023
• Study Completion: April 30, 2023
• Last Updated: December 24, 2024

Record last verified: 2024-03

Locations

CA (2)