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

Outset Medical

Status: Completed

Conditions: End Stage Renal Disease on Dialysis

Treatments: Device: Dialysate Flow Rate

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05947708

2019-03

Details and patient eligibility

About

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.

Full 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.

Enrollment: 41 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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41 participants in 2 patient groups

High FLow Rate

Active Comparator group

Description:

Flow Rate of 500ml/min or higher

Treatment:

Device: Dialysate Flow Rate

Low Flow Rate

Active Comparator group

Description:

Flow Rate of 300ml/min

Treatment:

Device: Dialysate Flow Rate