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

A Post-Market, Single Blind, Randomized Clinical Prospective Study on Intradialytic Symptoms in Subjects Treated With Qd 500vs Qd 300

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.

Study Overview

• Status: Completed
• Conditions: End Stage Renal Disease on Dialysis
• Intervention / Treatment: Device: Dialysate Flow Rate

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.

• Study Type: Interventional
• Enrollment (Actual): 41
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • San Jose, California, United States, 95112
      • Outset Medical

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: High FLow Rate; Flow Rate of 500ml/min or higher	Device: Dialysate Flow Rate; 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.
Active Comparator: Low Flow Rate; Flow Rate of 300ml/min	Device: Dialysate Flow Rate; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Outset Medical
• Collaborators: White Plains Hospital
• Investigators: Study Director: Christopher Gunter, Outset Medical

Study record dates

Study Major Dates

• Study Start (Actual): September 15, 2019
• Primary Completion (Actual): October 15, 2019
• Study Completion (Actual): January 15, 2020

Study Registration Dates

• First Submitted: June 21, 2023
• First Submitted That Met QC Criteria: July 7, 2023
• First Posted (Actual): July 17, 2023

Study Record Updates

• Last Update Posted (Actual): July 17, 2023
• Last Update Submitted That Met QC Criteria: July 7, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: Hemodialysis; Flow Rate
• Additional Relevant MeSH Terms: Pathologic Processes; Kidney Diseases; Urologic Diseases; Disease Attributes; Renal Insufficiency; Renal Insufficiency, Chronic; Chronic Disease; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Kidney Failure, Chronic; Pharmaceutical Solutions; Dialysis Solutions
• Other Study ID Numbers: 2019-03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The data derived from this clinical study will be shared via peer-reviewed journals and/or abstracts to nephrology centered conferences.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes