NCT05947708

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 41 (actual)
• Sponsor: Outset Medical · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• End Stage Renal Disease on Dialysis

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2019-09-15
• Primary completion: 2019-10-15
• Completion: 2020-01-15
• First posted: 2023-07-17
• Last updated: 2023-07-17

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study