Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 2:28 AM
Ignite Modification Date:
2025-12-25 @ 2:28 AM
NCT ID:
NCT01492634
Brief 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
Study:
NCT01492634
Study Brief:
Protocol Section:
NCT01492634