Randomized Bioimpedance vs Clinical Methods in Guiding Ultrafiltration in Hemodialysis Patients

Not Applicable

Completed

• Conditions: Volume Status; Haemodialyzed Patients
• Interventions: Other: Strict bioimpedance guided dry weight prescription

• Registration Number: NCT01828658
• Lead Sponsor: 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.

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.

Study Timeline

• Study Start: 2008-07
• Primary Completion: 2010-12
• Study Completion: 2011-12
• Study First Submitted: 2013-04-07
• Study First Submitted QC: 2013-04-08
• Study First Posted: 2013-04-10
• Status Verified: 2013-10
• Last Update Submitted: 2013-10-13
• Last Update Posted: 2013-10-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 131

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bioimpedance arm	Strict bioimpedance guided dry weight prescription	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.

Primary Outcome Measures

Name	Time	Method
All cause mortality	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

Name	Time	Method
Arterial stiffness	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).
Blood pressure values	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.
Overhydration	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.