The Study of Intradialytic Symptoms in Subjects Treated With Qd 500vs Qd 300

Study Overview
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Brief Summary
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Study Goal is to determine the impact of dialysate flow rate (Qd) on Subject reported dialysis related symptoms and on time to recovery post dialysis.

Detailed Description
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The objective of this study is to determine if Subjects who report dialysis symptoms while meeting adequacy (as determined by Kt/V of 1.2 or greater) on thrice weekly dialysis or who have a recovery time of at least 4 hours when treated on a conventional, i.e. non Tablo, hemodialysis device feel better with a reduced dialysate flow rate of 300ml/min based on an assessment of time to recovery post dialysis and Subject reported symptoms via a modified weekly ESAS survey.

Official Title
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A Post-Market, Single Blind, Randomized Clinical Prospective Study on Intradialytic Symptoms in Subjects Treated With Qd 500vs Qd 300

Conditions
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End Stage Renal Disease on Dialysis

Intervention / Treatment
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* Device: Dialysate Flow Rate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject has provided informed consent and has signed a Health Insurance Portability and Accountability Act of 1996 (HIPAA) compliant authorization statement. Subject is at least 18 of age. Subject has end stage renal disease (ESRD) adequately treated with thrice weekly dialysis. Subject is currently stable on dialysis for at least 3 months on a conventional dialysis machine and Qd of 500ml/min or higher with no change in the following dialysis prescription parameters over that time: Qb, Qd, Dialyzer, Time. Subject has a baseline Kt/V of greater than 1.2. Subject has a stable vascular access. Subject reports time to recovery of more than 4 hours or a modified ESAS with at least 5 symptoms of which at least 2 are rated as moderate (rating of 4-6) or severe (rating of 7-10). Exclusion Criteria: - 1. Subject is unable to complete the questionnaires. 2. Subject is pregnant or planning to become pregnant. 3. Subject is scheduled for a change in modality or expected kidney transplant in the next 3 months. 4. Any other documented condition that the Investigator feels would prevent the Subject from successful inclusion in the study.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Subjects will be randomized to either arm at a 1:1 ratio using excel's RANDBETWEEN function. Subjects will be randomly assigned a 0 or a 1. Subjects that are assigned '0' will go to Group 1, and subjects that are assigned '1' will go to Group 2.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: High FLow Rate<br>Flow Rate of 500ml/min or higher | Device: Dialysate Flow Rate<br>* Hemodialysis is completed with dialysate being used at differing flow rates. Flow rates will be modified to see if this is a causal factor in post-dialysis recovery.<br>|
| Active Comparator: Low Flow Rate<br>Flow Rate of 300ml/min | Device: Dialysate Flow Rate<br>* Hemodialysis is completed with dialysate being used at differing flow rates. Flow rates will be modified to see if this is a causal factor in post-dialysis recovery.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adequacy of Chronic Dialysis | Adequacy (as determined by Kt/V of 1.2 or greater) of patients treated with chronic (3x/wk), dialysis or who have a recovery time of more than 4 hours, when treated on a Tablo hemodialysis device versus conventional, i.e. non Tablo, hemodialysis device. | 4 weeks | 
| Post-Treatment Symptomology | Occurrence Rate of post-treatment symptoms (24hrs) when treated with a reduced dialysate flow rate of 300ml/min, based on an assessment of time to recovery post dialysis when using Tablo hemodialysis device, when compared to occurrence of post-treatment symptoms (24hrs) reported with dialysate flow rates ≥ 500 ml/min on conventional dialysis machines. | 0-24 Hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weekly Modified Edmonton Symptom Assessment System (ESAS) | Patient's assessment of symptom severity (i.e.,pain, tiredness, drowsiness, nausea, shortness of breath, appetite, depression, anxiety, and wellbeing). | 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hemodialysis, Flow Rate