End Stage Renal Disease on Dialysis
Conditions
Keywords
Hemodialysis, Flow Rate
Brief summary
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
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.
Interventions
DEVICEDialysate Flow Rate
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.
Sponsors
White Plains Hospital
Outset Medical
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
Only Subjects will be blinded to the dialysis device Qd.
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Subject has provided informed consent and has signed a Health Insurance Portability and Accountability Act of 1996 (HIPAA) compliant authorization statement. 2. Subject is at least 18 of age. 3. Subject has end stage renal disease (ESRD) adequately treated with thrice weekly dialysis. 4. 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. 5. Subject has a baseline Kt/V of greater than 1.2. 6. Subject has a stable vascular access. 7. 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adequacy of Chronic Dialysis | 4 weeks | 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. |
| Post-Treatment Symptomology | 0-24 Hours | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Weekly Modified Edmonton Symptom Assessment System (ESAS) | 4 weeks | Patient's assessment of symptom severity (i.e.,pain, tiredness, drowsiness, nausea, shortness of breath, appetite, depression, anxiety, and wellbeing). |
Countries
United States
Outcome results
None listed