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

JRCT ID: jRCT1062230034

Registered date:04/07/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Patients undergoing hemodialysis
• Date of first enrollment: 04/07/2023
• Target sample size: 20
• Study type: Interventional

Intervention(s)

[1] Types and methods of clinical trials
Single-center crossover open-label comparative study

[2]Method of randomization, blinding, etc.
Design: Single-center open-label crossover comparative study
Randomization: Yes (allocation by random numbers)
Level of blinding: unblinded

[3] Intervention period, observation period, and other details (including follow-up)
Study period: From the date of approval by the hospital director to March 31, 2024
Intervention period: 6 weeks

[4] Specific methods (including schedule)
While using the DCS-200Si dialysis monitor, a total of 6 weeks will be set up: (1) 2 weeks for the BV-UFC trial period, (2) 2 weeks for the dialysis period without BV-UFC, and (3) 2 weeks for the dialysis period with BV-UFC.
The research subjects will be divided into two groups by random numbers: (Group A) the group that will be intervened and observed in the order (1),(2),(3) and (Group B) the group that will be intervened and observed in the order (1),(3),(2).
(1) BV-UFC trial period (2 weeks)
A 2-week BV-UFC trial period will be set up and a dry weight will be set for each subject while using the BV-UFC for 2 weeks, referring to several test methods including physical findings, hemodynamics during hemodialysis, cardiothoracic ratio measured by chest X-ray, diameter of the inferior vena cava,% delta-BV, and degree of hANP level within the last 2 months. The dry weight and ultrafiltration rate during the BV-UFC period were set for each subject while using BV-UFC for 2 weeks, and the dry weight and ultrafiltration rate during the crossover period were not changed.
(2) Hemodialysis period without BV-UFC (2 weeks)
A total of 6 hemodialysis sessions for 2 weeks without BV-UFC. For patients on Monday-Wednesday-Friday hemodialysis, the dialysis period shall start on Monday of the first week, and for patients on Tuesday-Thursday-Saturday hemodialysis, the dialysis period shall start on Tuesday of the first week.
(3) Hemodialysis period with BV-UFC (2 weeks)
BV-UFC is used at the ultrafiltration rate set during the acclimation period for a total of 6 hemodialysis sessions over a 2-week period. For patients on dialysis on Monday, Wednesday, and Friday, the dialysis period shall start on Monday of the first week, and for patients on dialysis on Tuesday, Thursday, and Saturday, the dialysis period shall start on Tuesday of the first week.
Since the two weekend days between (1) and (2) and (3) are non-dialysis days, the influence of the previous period is considered to be small, and no washout period is set in this study.

Outcome(s)

Primary Outcome

Average plasma refilling rate during dialysis: PRR (mL/kg/hr)
Average PRR (L/hr) recorded in DCS-200Si every 20 seconds during dialysis and corrected by body weight (kg).
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.
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.
Circulating blood volume increase during the measurement interval = circulating blood volume multiplied by the BV change during the measurement interval
Circulating blood volume = pre-dialysis weight/13
Time of measurement interval = 60 seconds
Calculated by

Secondary Outcome

Blood pressure variation during dialysis
Difference between systolic blood pressure before starting dialysis and systolic blood pressure before returning blood
The number of times of hypotension during dialysis, blood pressure variability (standard deviation (SD) or coefficient of variation (CV), variability independent of the mean (VIM), etc. are calculated as blood pressure variability). (VIM), etc., as blood pressure variability)
Dialysis hypotension is defined as a sudden drop in blood pressure of 20 mmHg or more as systolic blood pressure or a symptomatic drop in mean blood pressure of 10 mmHg or more during dialysis. Basically, blood pressure should be measured every 20 minutes during hemodialysis. Even if blood pressure is measured multiple times within 20 minutes due to symptoms such as feeling unwell, only the lowest systolic blood pressure should be recorded as the valid count.
The number of times the systolic blood pressure decreased by more than 20% or 30% compared to the systolic blood pressure before the start of hemodialysis.
Even if blood pressure is measured multiple times within a 20-minute period due to symptoms such as feeling unwell, only the lowest systolic blood pressure should be recorded as the valid count.

Amount of vasopressors used during hemodialysis (per hemodialysis session)

Percentage of patients achieving target ultrafiltration rate at the end of hemodialysis

The target ultrafiltration rate at the end of hemodialysis is determined to be achieved when the target ultrafiltration rate is +-0.3 kg.

Number of dialysis monitoring device operations and procedures by medical staff during dialysis
The number of times the ultrafiltration rate was changed, blood pressure was alarmed, Trendelenburg position , and the rate of vasopressors was changed, as well as the average number of times per hemodialysis session (excluding venous pressure alarms, dialysate pressure alarms, and other vasucular access related alarms).

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 90age old
• Gender: Both

Include 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

Exclude 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.

Related Information

• Primary Sponsor: Hamada Shintaro