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CompletedNCT01492634Updated Feb 28, 2014

Optimizing Fluid Status

An interventional study of Prescription of post-dialytic weight based on BCM device in Hypotension During Dialysis, sponsored by Francisco Maduell. Completed at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-02-28.

Sponsored by Francisco Maduell · Not applicable and Interventional

Phase
Not applicable
Study type
Interventional
Enrollment
56
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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

02

Conditions studied

  • Hypotension During Dialysis

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Keywords

  • bioimpedance
  • overhydration
  • dry weight
03

In context

Hypotension

1,003 studies on the registry are indexed under Hypotension; 173 are open to participants now.

This study's enrollment of 56 is below the median of 80 across 675 interventional studies indexed under Hypotension.

Browse Hypotension studies →

Lead sponsor

This is the only study on the registry with Francisco Maduell as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
56 participants (actual)

Interventions

  • OtherPrescription 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.

    Also known as: BCM or Body Composition Monitor Fresenius Medical Care

06

What researchers measure

Primary outcomes

  1. intra-individual difference in TAFO between study start and study end

    Time frame: 3 months

Secondary outcomes

  1. Comparison between start and end of treatment will be performed for Pre-dialytic overhydration (OH)

    Time frame: 3 months

  2. 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)

    Time frame: 3 months

  3. SF 36 total score and sub-scores as calculated according to official guidelines,

    Time frame: 3 months

  4. BNP

    Time frame: 3 months

  5. Blood pressure

    Time frame: 3 months

  6. laboratory parameters (sodium, calcium, potassium, chloride, haematocrit, haemoglobin, albumin, total protein, urea, creatinine, mean corpuscular volume, C-reactive protein, transferrin saturation, ferritin).

    Time frame: 3 months

  7. Change from Baseline in Medication at 12 weeks (erythropoetin, iron, blood pressure medication)

    Time frame: 3 months

  8. Change from baseline in intra-dialytic events (hypotension, cramps)

    Time frame: 3 months

  9. Change from baseline in Residual Renal Function

    Baseline Residual renal function, measured as Kt/V residual, wil be compared with the Residual renal function at the end of 12 weeks.

    Time frame: 3 months

  10. Hospitalisation

    Time frame: 3 months

07

Study locations

1 site
  • Dialysis Units, Hospital Clínic
    Barcelona, 08036, Spain
08

References and documents

Publications

  • 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. PubMed 23949235 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 28, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01492634
Lead sponsor
Francisco Maduell
Collaborators
Fresenius Medical Care Europe
Responsible party
Francisco Maduell (Principal Investigator; Head of Dialysis Section, Hospital Clinic of Barcelona) — Sponsor-investigator
First posted
Dec 15, 2011
Start date
Nov 2011
Primary completion
Dec 2011
Completion
Feb 2012
Last update
Feb 28, 2014

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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