End Stage Renal Disease on Dialysis Clinical Trial
Official title:
A Post-Market, Single Blind, Randomized Clinical Prospective Study on Intradialytic Symptoms in Subjects Treated With Qd 500vs Qd 300
Verified date | June 2023 |
Source | Outset Medical |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 41 |
Est. completion date | January 15, 2020 |
Est. primary completion date | October 15, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | Outset Medical | San Jose | California |
Lead Sponsor | Collaborator |
---|---|
Outset Medical | White Plains Hospital |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | 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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