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
|Hypotension During Dialysis||Other: Prescription of post-dialytic weight based on BCM device|
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
|Official Title:||Clinical Investigation Plan Optimizing Fluid Status|
- intra-individual difference in TAFO between study start and study end [ Time Frame: 3 months ]
- Comparison between start and end of treatment will be performed for Pre-dialytic overhydration (OH) [ Time Frame: 3 months ]
- Comparison between start and end of treatment will be performed for number of patients in target range (TAFO from -0.2 L to 1.3 L) [ Time Frame: 3 months ]
- SF 36 total score and sub-scores as calculated according to official guidelines, [ Time Frame: 3 months ]
- BNP [ Time Frame: 3 months ]
- Blood pressure [ Time Frame: 3 months ]
- laboratory parameters (sodium, calcium, potassium, chloride, haematocrit, haemoglobin, albumin, total protein, urea, creatinine, mean corpuscular volume, C-reactive protein, transferrin saturation, ferritin). [ Time Frame: 3 months ]
- Change from Baseline in Medication at 12 weeks (erythropoetin, iron, blood pressure medication) [ Time Frame: 3 months ]
- Change from baseline in intra-dialytic events (hypotension, cramps) [ Time Frame: 3 months ]
- Change from baseline in Residual Renal Function [ Time Frame: 3 months ]Baseline Residual renal function, measured as Kt/V residual, wil be compared with the Residual renal function at the end of 12 weeks.
- Hospitalisation [ Time Frame: 3 months ]
|Study Start Date:||November 2011|
|Study Completion Date:||February 2012|
|Primary Completion Date:||December 2011 (Final data collection date for primary outcome measure)|
Other: Prescription of post-dialytic weight based on BCM device
Prescription of post-dialytic weight target: On a weekly base, the patients are pre-dialytically measured by BCM (body composition monitor).
The time average fluid overload (TAFO) determines the target range. TAFO is defined as the mean value of pre- and post-dialytic overhydration (TAFO = (OHpre+OHpost)/2). The target range is set asymmetrically around a TAFO of 0.8, from -1.0 L to +0.5, i.e. the TAFO target range will be from -0.2 L to 1.3 L.
Prescription steps will be calculated weekly for all study patients. TAFO < -0.2 L: Increase post-dialytic weight by Cw x 0.5 kg/week, TAFO between -0.2 to 1.3 L: No action, TAFO between 1.3 to 2.8 L Decrease post-dialytic weight by Cw x 0.5 kg/week, TAFO > 2.8 L: Decrease post-dialytic weight by Cw x 1.0 kg/week.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01492634
|Dialysis Units, Hospital Clínic|
|Barcelona, Spain, 08036|