Back to resultsThe Study of Intradialytic Symptoms in Subjects Treated With Qd 500vs Qd 300
Primary Purpose
End Stage Renal Disease on Dialysis
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Dialysate Flow Rate
Sponsored by
About this trial
This is an interventional treatment trial for End Stage Renal Disease on Dialysis focused on measuring Hemodialysis, Flow Rate
Eligibility Criteria
Inclusion Criteria: 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). 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.
Sites / Locations
- Outset Medical
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
High FLow Rate
Low Flow Rate
Arm Description
Flow Rate of 500ml/min or higher
Flow Rate of 300ml/min
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
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).
Full Information
NCT ID
NCT05947708
First Posted
June 21, 2023
Last Updated
July 7, 2023
Sponsor
Outset Medical
Collaborators
White Plains Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05947708
Brief Title
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
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
September 15, 2019 (Actual)
Primary Completion Date
October 15, 2019 (Actual)
Study Completion Date
January 15, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Outset Medical
Collaborators
White Plains Hospital
4. Oversight
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
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
End Stage Renal Disease on Dialysis
Keywords
Hemodialysis, Flow Rate
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
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.
Masking
Participant
Masking Description
Only Subjects will be blinded to the dialysis device Qd.
Allocation
Randomized
Enrollment
41 (Actual)
8. Arms, Groups, and Interventions
Arm Title
High FLow Rate
Arm Type
Active Comparator
Arm Description
Flow Rate of 500ml/min or higher
Arm Title
Low Flow Rate
Arm Type
Active Comparator
Arm Description
Flow Rate of 300ml/min
Intervention Type
Device
Intervention Name(s)
Dialysate Flow Rate
Intervention Description
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.
Primary Outcome Measure Information:
Title
Adequacy of Chronic Dialysis
Description
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.
Time Frame
4 weeks
Title
Post-Treatment Symptomology
Description
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.
Time Frame
0-24 Hours
Secondary Outcome Measure Information:
Title
Weekly Modified Edmonton Symptom Assessment System (ESAS)
Description
Patient's assessment of symptom severity (i.e.,pain, tiredness, drowsiness, nausea, shortness of breath, appetite, depression, anxiety, and wellbeing).
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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).
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christopher Gunter
Organizational Affiliation
Outset Medical
Official's Role
Study Director
Facility Information:
Facility Name
Outset Medical
City
San Jose
State/Province
California
ZIP/Postal Code
95112
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
The data derived from this clinical study will be shared via peer-reviewed journals and/or abstracts to nephrology centered conferences.
Learn more about this trial
The Study of Intradialytic Symptoms in Subjects Treated With Qd 500vs Qd 300
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