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| Name | Class |
|---|---|
| White Plains Hospital | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High FLow Rate | Active Comparator | Flow Rate of 500ml/min or higher |
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| Low Flow Rate | Active Comparator | Flow Rate of 300ml/min |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dialysate Flow Rate | Device | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
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.
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| Name | Affiliation | Role |
|---|---|---|
| Christopher Gunter | Outset Medical | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Outset Medical | San Jose | California | 95112 | United States |
The data derived from this clinical study will be shared via peer-reviewed journals and/or abstracts to nephrology centered conferences.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 15, 2019 | Jun 21, 2023 | Prot_000.pdf |
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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.
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Only Subjects will be blinded to the dialysis device Qd.