Optimizing Fluid Status

Clinical Investigation Plan Optimizing Fluid Status

Title of study: Optimizing Fluid Status

Study code: HD-IIT-01-E

Study design: Prospective open design in study centre at two locations

Applied medical device: Body Composition Monitor (BCM) for determination of fluid overload and dry weight

Aim of the study: To improve the fluid status in chronic HD patients (measured as OH (overhydration) or TAFO (time averaged fluid overload)) based on BCM measurements. Up to now, the BCM was occasionally applied in both locations of the study centre.

Study hypothesis: Regular measurement of fluid status (assessed by BCM) and display of dry weight (post-weight plan)will have significant consequences, namely a decrease of the:

• time averaged fluid overload (TAFO),
• proportion of patients with severe overhydration OH > 2.5 L,or OH/ECW > 15 %)
• proportion of dehydrated patients (OH < -1.0 L, or OH < -7 %),
• mean overhydration,
• variance of overhydration,
• time outside the reference range (-1.0L < OH < 2.5L).

Devices used in this study: Dialysis machine 5008 equipped with Blood Pressure Monitor BPM, Blood Volume Monitor BVM, Blood Temperature Monitor BTM, and Online Clearance Monitor OCM ; Body Composition Monitor BCM ; Data management software / database system NephroLink Disposables used in this study: BVM blood lines and BCM electrodes

Patients: 60 patients

Inclusion Criteria:

• Chronic renal failure stage V
• Treatment thrice weekly with HD or on-line HDF for at least 6 months prior to inclusion
• Ability to understand the nature and requirements of the study
• Age: at least 18 years
• Signed informed consent.

Exclusion Criteria:

• Interventional clinical study during the preceding 30 days or previous participation in the same study
• Acute or chronic infection (HIV, Hepatitis B or C, ...)
• Severe disease (malignant tumour, tuberculosis ...)
• Usually single needle HD
• Problems with shunt or high recirculation,
• Severe intra-dialytic blood pressure instability in the last month
• Instable angina pectoris
• Major amputation at arm or leg, or a pacemaker.