Clinical trial NCT01492634: Optimizing Fluid Status
Official title: Clinical Investigation Plan Optimizing Fluid Status
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypotension During Dialysis
Keywords: bioimpedance
overhydration
dry weight
Lead sponsor: Hospital Clinic of Barcelona
Sponsor class: OTHER
Collaborators: name: Fresenius Medical Care Europe
First posted: 2011-12-15
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

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


Eligibility criteria: Inclusion Criteria:

* Chronic renal failure stage V
* 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:

* Interventional clinical study during the preceding 30 days or previous participation in the same study
* 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.

Primary outcomes:
measure: intra-individual difference in TAFO between study start and study end
timeFrame: 3 months
Secondary outcomes:
measure: Comparison between start and end of treatment will be performed for Pre-dialytic overhydration (OH)
timeFrame: 3 months
measure: 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)
timeFrame: 3 months
measure: SF 36 total score and sub-scores as calculated according to official guidelines,
timeFrame: 3 months
measure: BNP
timeFrame: 3 months
measure: Blood pressure
timeFrame: 3 months
measure: laboratory parameters (sodium, calcium, potassium, chloride, haematocrit, haemoglobin, albumin, total protein, urea, creatinine, mean corpuscular volume, C-reactive protein, transferrin saturation, ferritin).
timeFrame: 3 months
measure: Change from Baseline in Medication at 12 weeks (erythropoetin, iron, blood pressure medication)
timeFrame: 3 months
measure: Change from baseline in intra-dialytic events (hypotension, cramps)
timeFrame: 3 months
measure: Change from baseline in Residual Renal Function
timeFrame: 3 months
measure: Hospitalisation
timeFrame: 3 months
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Dialysis Units, Hospital Clínic
Study officials:
References:
citation: 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.