Comparison of the Blood Volume Monitor in the 6008 CAREsystem with the Blood Volume Monitor in the 5008 Therapy System, and comparison with the Crit-Line system

Comparison of the Blood Volume Monitor in the 6008 CAREsystem with the Blood Volume Monitor in the 5008 Therapy System, and comparison with the Crit-Line system - HD-BVM-68-D

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00024720

Enrollment

Registered

2021-03-17

Start date

2018-11-13

Completion date

Unknown

Last updated

2025-04-07

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

Conditions

N18.5

Interventions

Group 1: Data is collected during the study from prospective study treatments with the 6008 CAREsystem. The study duration includes four weeks of continuous trice weekly treatments per patient. Group

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: General: - Minimum age of 18 years - Informed consent signed and dated by study patient and investigator / authorized physician - Ability to understand the nature and requirements of the study - Dialysis treatment thrice weekly Study-specific: - Treatments with the 5008 Therapy System with its blood tubing system inclusive BVM with application of the opt ion BVM in control mode for at least 4 weeks directly before the switch to the 6008 CAREsystem

Exclusion criteria

Exclusion criteria: - Any condition which could interfere with the patient's ability to comply with the study. This decision is at the discretion of the treating physician and relates to the general good condition of the patient (e.g. absence of any acute condition, e.g. infection or mental problem which might give reason for concern etc.). - Ongoing participation in an interventional clinical study or during the preceding 30 days - Previous participation in this study - Pregnancy (pregnancy test will be conducted with female patients aged = 55 years) or lactation period Study-specific: - Conditions that limit the application of the applied medical devices 6008 CAREsystem and 6008 CAREset inclusive BVM cuvette, or the applied Body Composition Monitor (e.g. massive amputation) - Pre-dilution online hemodiafiltration (due to dilution of blood in Crit-Line blood chamber)

Design outcomes

Primary

Measure	Time frame
Comparison of the 6008 CAREsystem with BVM control (6008+) and the 5008 Therapy System with BVM control (5008+) concerning efficacy: Mean dialysis dose (Kt/V)	—

Secondary

Measure	Time frame
Comparison of the 6008 CAREsystem with BVM control (6008+) and the 5008 Therapy System with BVM control (5008+) concerning efficacy: Ultrafiltration volume (ml) and Fluid overload (ml)	—

Countries

Germany

Contacts

Public ContactSebastian Zschätzsch

Georg-Haas-Dialysezentrum der PHV

zschaetzsch@nieren-praxis.de+49 641 922340

Outcome results

None listed

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