Randomized Bioimpedance vs Clinical Methods in Guiding Ultrafiltration in Hemodialysis Patients (BIAHD)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01828658|
Recruitment Status : Completed
First Posted : April 10, 2013
Last Update Posted : October 16, 2013
|Condition or disease||Intervention/treatment||Phase|
|Haemodialyzed Patients Volume Status||Other: Strict bioimpedance guided dry weight prescription||Not Applicable|
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 (Clinical Trial)|
|Actual Enrollment :||131 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Care Provider)|
|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|
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).
- 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.
- 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).
- 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.
- 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.
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
|Principal Investigator:||Adrian Covic, Professor||University of Medicine and Pharmacy Iasi, "Dr. C.I.Parhon" University Hospital Iasi, Nephrology Department|