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

Bioimpedance Versus Clinical Methods in Guiding Ultrafiltration in Hemodialysis Patients: a Randomized Trial

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.

Study Overview

• Status: Completed
• Conditions: Haemodialyzed Patients; Volume Status
• Intervention / Treatment: Other: Strict bioimpedance guided dry weight prescription

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 Type: Interventional
• Enrollment (Actual): 131
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
All cause mortality	We assessed all-cause mortality in the two arms of the study at the end of intervention period.	2,5 years follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Arterial stiffness	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).	3,5 years
Blood pressure values	In both arms, blood pressure was measured predialysis every 3 months and noted as a mean of the previous 3 predialysis BP values.	2,5 years
Overhydration	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.	2,5 years

Collaborators and Investigators

• Sponsor: Grigore T. Popa University of Medicine and Pharmacy
• Investigators: Principal Investigator: Adrian Covic, Professor, University of Medicine and Pharmacy Iasi, "Dr. C.I.Parhon" University Hospital Iasi, Nephrology Department

Publications and helpful links

General Publications

• Onofriescu M, Hogas S, Voroneanu L, Apetrii M, Nistor I, Kanbay M, Covic AC. Bioimpedance-guided fluid management in maintenance hemodialysis: a pilot randomized controlled trial. Am J Kidney Dis. 2014 Jul;64(1):111-8. doi: 10.1053/j.ajkd.2014.01.420. Epub 2014 Feb 28.

Study record dates

Study Major Dates

• Study Start: July 1, 2008
• Primary Completion (ACTUAL): December 1, 2010
• Study Completion (ACTUAL): December 1, 2011

Study Registration Dates

• First Submitted: April 7, 2013
• First Submitted That Met QC Criteria: April 8, 2013
• First Posted (ESTIMATE): April 10, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): October 16, 2013
• Last Update Submitted That Met QC Criteria: October 13, 2013
• Last Verified: October 1, 2013

More Information

Terms related to this study

• Keywords: mortality; hemodialysis; arterial stiffness; fluid management; bioimpedance
• Other Study ID Numbers: BCM0913