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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT1062230034

Enrollment

Registered

2023-07-04

Start date

2023-06-19

Completion date

Unknown

Last updated

2025-07-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients undergoing hemodialysis hemodialysis

Interventions

[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 R

D018592

single-center open-label crossover study

Eligibility

Sex/Gender

All

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
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	—

Measure

Time frame

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

Measure	Time frame
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).	—

Measure

Time frame

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).

—

Contacts

Public ContactShintaro Hamada

Department of Nephrology, Sanin Rosai Hospital

hamashin7650@gmail.com+81-859-33-8181

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Feb 4, 2026