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Randomized Bioimpedance vs Clinical Methods in Guiding Ultrafiltration in Hemodialysis Patients (BIAHD)

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ClinicalTrials.gov Identifier: NCT01828658
Recruitment Status : Completed
First Posted : April 10, 2013
Last Update Posted : October 16, 2013
Sponsor:
Information provided by (Responsible Party):
Professor Adrian Covic, Grigore T. Popa University of Medicine and Pharmacy

Brief Summary:
The investigators developed a prospective, randomized, controlled trial to compare strict volume control using bioimpedance (using the BCM - Body Composition Monitor device) versus traditional clinical volume control in hemodialysis patients and the impact on mortality, hydration status, blood pressure values and arterial stiffness.

Condition or disease Intervention/treatment Phase
Haemodialyzed Patients Volume Status Other: Strict bioimpedance guided dry weight prescription Not Applicable

Detailed Description:

The investigators developed a randomized controlled study to compare exclusively bioimpedance guided ultrafiltration in hemodialysis patients versus traditional methods for volume assessment.

The duration of the study was 3,5 years.

During the first 2,5 years of the study all enrolled patients were randomized using a block randomization algorithm in two arms.

In the interventional arm the post-dialysis dry weight was prescribed exclusively using the BCM device (Body Composition Monitor - Fresenius Medical Care, Germany).

In the control arm dry weight assessment was done by traditional clinical methods.

In both arms,during the intervention period (2,5 years) BCM measurements were performed every 3 months before dialysis, but only in the interventional arm the values were disclosed to the medical personnel and used to guide the dry weight and ultrafiltration volumes.

In the control arm (clinical), both patients and caregivers were fully blinded from the BCM results.

The BCM device measures for each patient an ideal dry weight interval ( +/- 1.1 kg). In the interventional arm, the prescribed dry weights of the patients were strictly maintained in the ideal weight interval (+/- 1.1 kg) proposed by the BCM device.

Primary outcome was all cause-mortality compared in the strict bioimpedance arm versus the clinical (control) arm and was assessed at 2,5 years.

Secondary end-points, assessed during the randomization period (2,5 years), were to compare blood pressure (determined pre dialysis), arterial stiffness and relative fluid overload (RFO = overhydration/ total body water), as measured by the BCM device.

During the last year of the study, all patients were left free of any intervention, and only arterial stiffness was assessed a third time at 3,5 years.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 131 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: Bioimpedance Versus Clinical Methods in Guiding Ultrafiltration in Hemodialysis Patients: a Randomized Trial
Study Start Date : July 2008
Actual Primary Completion Date : December 2010
Actual Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dialysis

Arm Intervention/treatment
No Intervention: Clinical (control)
In the clinical arm, dry weight and ultrafiltration prescription were done exclusively using traditional clinical methods of volume assessment.
Active Comparator: Bioimpedance arm
Strict bioimpedance guided dry weight prescription arm. All patients dry weights were permanently maintained in the dry weight interval recommended by the BCM device (+/- 1,1 kg); BCM measurements were performed every 3 months.
Other: Strict bioimpedance guided dry weight prescription
Post dialysis patient dry weight was exclusively prescribed using the ideal weight measured by the BCM device (+/- 1.1 Kg).




Primary Outcome Measures :
  1. All cause mortality [ Time Frame: 2,5 years follow-up ]
    We assessed all-cause mortality in the two arms of the study at the end of intervention period.


Secondary Outcome Measures :
  1. Arterial stiffness [ Time Frame: 3,5 years ]

    Arterial stiffness was evaluated by applanation tonometry, measuring pulse wave velocity, and was done with a SphygmoCor® device (AtCor Medical, Westmead, Sydney, Australia).

    Measurements were performed in both arms at baseline, end of intervention (2,5 years) and at the end of the study (3,5 years).


  2. Blood pressure values [ Time Frame: 2,5 years ]
    In both arms, blood pressure was measured predialysis every 3 months and noted as a mean of the previous 3 predialysis BP values.

  3. Overhydration [ Time Frame: 2,5 years ]
    Overhydration was evaluated in both arms of the study using the Body Composition Monitor (BCM device), every 3 months. Overhydration was quantified as Relative fluid overload (RFO = overhydration/ total body water - as measured by the BCM.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • older than 18-year
  • on chronic hemodialysis for more than 3 months

Exclusion Criteria:

- life expectancy of less than 1 year

Presence of a condition that may interfere with the determination of dry weight using the Body Composition Monitor (R):

  • severe ascites (decompensated liver failure)
  • limb amputations
  • cardiac stent, pacemaker or defibrillator
  • hip prosthetic
  • pregnancy
  • mental deficiency (impossibility to give consent)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01828658


Sponsors and Collaborators
Grigore T. Popa University of Medicine and Pharmacy
Investigators
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Principal Investigator: Adrian Covic, Professor University of Medicine and Pharmacy Iasi, "Dr. C.I.Parhon" University Hospital Iasi, Nephrology Department
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Professor Adrian Covic, Professor Dr., Grigore T. Popa University of Medicine and Pharmacy
ClinicalTrials.gov Identifier: NCT01828658    
Other Study ID Numbers: BCM0913
First Posted: April 10, 2013    Key Record Dates
Last Update Posted: October 16, 2013
Last Verified: October 2013
Keywords provided by Professor Adrian Covic, Grigore T. Popa University of Medicine and Pharmacy:
hemodialysis
fluid management
bioimpedance
mortality
arterial stiffness