Optimizing Fluid Status

Hypotension During Dialysis Clinical Trial

Official title: Clinical Investigation Plan Optimizing Fluid Status

Status Completed

Clinical Trial 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

Clinical Trial Description

n/a

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Hypotension
• Hypotension During Dialysis

• NCT number: NCT01492634
• Study type: Interventional
• Source: Hospital Clinic of Barcelona
• Status: Completed
• Phase: N/A
• Start date: November 2011
• Completion date: February 2012