Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
56 participants
INTERVENTIONAL
2011-11-30
2012-02-29
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
NONE
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Fresenius Medical Care Europe
UNKNOWN
Francisco Maduell
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Francisco Maduell
Principal Investigator; Head of Dialysis Section
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Dialysis Units, Hospital Clínic
Barcelona, Barcelona, Spain
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Moissl U, Arias-Guillen M, Wabel P, Fontsere N, Carrera M, Campistol JM, Maduell F. Bioimpedance-guided fluid management in hemodialysis patients. Clin J Am Soc Nephrol. 2013 Sep;8(9):1575-82. doi: 10.2215/CJN.12411212. Epub 2013 Aug 15.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
HD-IIT-01-E
Identifier Type: -
Identifier Source: org_study_id