A single-center open-label crossover study of the clinical utility and safety of the BV-UFC system of the DCS-200Si dialysis monitor

Not Applicable

Recruiting

• Conditions: Patients undergoing hemodialysis; hemodialysis; D006435

• Registration Number: JPRN-jRCT1062230034
• Lead Sponsor: Hamada Shintaro

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-07-04
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

(1) Patients who give written consent to participate in this study of their own free will.
(2)Hemodialysis patients who are outpatients or inpatients undergoing hemodialysis (regardless of the underlying disease)
(3)Patients who are between 20 and 90 years old (regardless of gender) at the time of consent
(4)Patients who can be get a blood flow rate of 200 mL/min or more by vascular access
(5)Patients who have been receiving hemodialysis for at least 3 months at the time of participation in this study

Exclusion Criteria

Of those who meet the above selection criteria, those who meet any of the following criteria shall not be eligible for enrollment.
(1) Patients participating in other clinical research or clinical trials
(2)Those who are pregnant
(3)Patients who have vascular access recirculation
(4) Patients who are deemed by the investigator to be inappropriate to participate in the study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Average plasma refilling rate during dialysis: PRR (mL/kg/hr)<br>Average PRR (L/hr) recorded in DCS-200Si every 20 seconds during dialysis and corrected by body weight (kg).<br>Average PRR (mL/kg/hr) is calculated for the entire period of dialysis, and for 0-1 hour, 1-2 hours, and 2-3 hours after the start of dialysis.<br>The PRR value is automatically calculated by the dialysis monitoring device as PRR=(amount of water removed during the measurement interval + increase in circulating blood volume during the measurement interval)/time during the measurement interval.<br>Circulating blood volume increase during the measurement interval = circulating blood volume multiplied by the BV change during the measurement interval<br>Circulating blood volume = pre-dialysis weight/13<br>Time of measurement interval = 60 seconds<br>Calculated by