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

End Stage Renal Disease on Dialysis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05947708
• Other study ID #: 2019-03
• Status: Completed
• Phase: N/A
• Start date: September 15, 2019
• Est. completion date: January 15, 2020

Study information

• Verified date: June 2023
• Source: Outset Medical
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: January 15, 2020
• Est. primary completion date: October 15, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• End Stage Renal Disease on Dialysis
• Kidney Failure, Chronic

Intervention

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.

Locations

Country	Name	City	State
United States	Outset Medical	San Jose	California

Sponsors (2)

Lead Sponsor	Collaborator
Outset Medical	White Plains Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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