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

NCT05947708 | Completed FDA Device

• 1 other identifier: 2019-03
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

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.

Conditions

End Stage Renal Disease on Dialysis

Keywords

Hemodialysis; Flow Rate

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (1)

• Weekly Modified Edmonton Symptom Assessment System (ESAS)

  4 weeks

Study Arms (2)

High FLow Rate

ACTIVE COMPARATOR

Flow Rate of 500ml/min or higher

Device: Dialysate Flow Rate

Low Flow Rate

ACTIVE COMPARATOR

Flow Rate of 300ml/min

Device: Dialysate Flow Rate

Interventions

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.

High FLow Rate; Low Flow Rate

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject has provided informed consent and has signed a Health Insurance Portability and Accountability Act of 1996 (HIPAA) compliant authorization statement.
• Subject is at least 18 of age.
• Subject has end stage renal disease (ESRD) adequately treated with thrice weekly dialysis.
• 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.
• Subject has a baseline Kt/V of greater than 1.2.
• Subject has a stable vascular access.
• 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).

You may not qualify if:

• \- 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.

Sponsors & Collaborators

• Outset Medical: lead
• White Plains Hospital: collaborator

Study Sites (1)

Outset Medical

San Jose, California, 95112, United States

Location

Study Officials

• Christopher Gunter

  Outset Medical

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Only Subjects will be blinded to the dialysis device Qd.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: June 21, 2023
• First Posted: July 17, 2023
• Study Start: September 15, 2019
• Primary Completion: October 15, 2019
• Study Completion: January 15, 2020
• Last Updated: July 17, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)