Clinical trial NCT05947708: The Study of Intradialytic Symptoms in Subjects Treated With Qd 500vs Qd 300
Official title: A Post-Market, Single Blind, Randomized Clinical Prospective Study on Intradialytic Symptoms in Subjects Treated With Qd 500vs Qd 300
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: End Stage Renal Disease on Dialysis
Keywords: Hemodialysis
Flow Rate
Lead sponsor: Outset Medical
Sponsor class: INDUSTRY
Collaborators: name: White Plains Hospital
First posted: 2023-07-17
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Adequacy of Chronic Dialysis
timeFrame: 4 weeks
measure: Post-Treatment Symptomology
timeFrame: 0-24 Hours
Secondary outcomes:
measure: Weekly Modified Edmonton Symptom Assessment System (ESAS)
timeFrame: 4 weeks
Other outcomes:
Locations:
city: San Jose
country: United States
facility: Outset Medical
state: California
Study officials:
affiliation: Outset Medical
name: Christopher Gunter
role: STUDY_DIRECTOR
References: