Optimizing Fluid Status

This study has been completed.
Sponsor:
Collaborator:
Fresenius Medical Care Europe
Information provided by (Responsible Party):
Francisco Maduell, Hospital Clinic of Barcelona
ClinicalTrials.gov Identifier:
NCT01492634
First received: December 7, 2011
Last updated: February 27, 2014
Last verified: December 2011
  Purpose

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


Condition Intervention
Hypotension During Dialysis
Other: Prescription of post-dialytic weight based on BCM device

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Clinical Investigation Plan Optimizing Fluid Status

Resource links provided by NLM:


Further study details as provided by Hospital Clinic of Barcelona:

Primary Outcome Measures:
  • intra-individual difference in TAFO between study start and study end [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Comparison between start and end of treatment will be performed for Pre-dialytic overhydration (OH) [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • SF 36 total score and sub-scores as calculated according to official guidelines, [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • BNP [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Blood pressure [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Change from Baseline in Medication at 12 weeks (erythropoetin, iron, blood pressure medication) [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Change from baseline in intra-dialytic events (hypotension, cramps) [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Change from baseline in Residual Renal Function [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Baseline Residual renal function, measured as Kt/V residual, wil be compared with the Residual renal function at the end of 12 weeks.

  • Hospitalisation [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Enrollment: 56
Study Start Date: November 2011
Study Completion Date: February 2012
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Other: 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 Name: BCM or Body Composition Monitor Fresenius Medical Care
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01492634

Locations
Spain
Dialysis Units, Hospital Clínic
Barcelona, Spain, 08036
Sponsors and Collaborators
Francisco Maduell
Fresenius Medical Care Europe
  More Information

Publications:
Responsible Party: Francisco Maduell, Principal Investigator; Head of Dialysis Section, Hospital Clinic of Barcelona
ClinicalTrials.gov Identifier: NCT01492634     History of Changes
Other Study ID Numbers: HD-IIT-01-E
Study First Received: December 7, 2011
Last Updated: February 27, 2014
Health Authority: Spain: Comité Ético de Investigación Clínica

Keywords provided by Hospital Clinic of Barcelona:
bioimpedance
overhydration
dry weight

Additional relevant MeSH terms:
Hypotension
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on July 23, 2014