Skip to main content
OpenTrials
Completed

NCT Number: NCT05947708

The Study of 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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Outset Medical

San Jose, California, 95112, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.
  • Any other documented condition that the Investigator feels would prevent the Subject from successful inclusion in the study.

Treatment and study plan

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.

Primary outcomes

  1. Adequacy of Chronic Dialysis

    Time frame: 4 weeks

    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.

  2. Post-Treatment Symptomology

    Time frame: 0-24 Hours

    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 outcomes

  1. Weekly Modified Edmonton Symptom Assessment System (ESAS)

    Time frame: 4 weeks

    Patient's assessment of symptom severity (i.e.,pain, tiredness, drowsiness, nausea, shortness of breath, appetite, depression, anxiety, and wellbeing).

Sponsors and collaborators

Lead sponsor

Outset Medical

Industry

Collaborators

  • White Plains Hospital

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2020
First posted
Jul 17, 2023
Registry last updated
Jul 17, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.