NCT01492634

Optimizing Fluid Status

Clinical Investigation Plan Optimizing Fluid Status

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 56 (actual)
• Sponsor: Francisco Maduell · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Conditions

• Hypotension During Dialysis

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2011-11-01
• Primary completion: 2011-12-01
• Completion: 2012-02-01
• First posted: 2011-12-15
• Last updated: 2014-02-28

Locations

1 site across 1 country: Spain