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NCT Number: NCT01492634

Optimizing Fluid Status

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

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Key information

Conditions

Hypotension During Dialysis Chemically-Induced Disorders Metabolic Diseases Nutritional and Metabolic Diseases Poisoning Water Intoxication Water-Electrolyte Imbalance

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dialysis Units, Hospital Clínic

Barcelona, 08036, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Prescription of post-dialytic weight based on BCM device

Other

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 names: BCM or Body Composition Monitor Fresenius Medical Care

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

    Time frame: 3 months

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

  10. Hospitalisation

    Time frame: 3 months

Sponsors and collaborators

Lead sponsor

Francisco Maduell

Other

Collaborators

  • Fresenius Medical Care Europe

Registry information

Official study title

Clinical Investigation Plan Optimizing Fluid Status

Important dates

Study start
2011
Primary completion
2011
Study completion
2012
First posted
Dec 15, 2011
Registry last updated
Feb 28, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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