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Response Options to Blood Volume Monitoring in Fluid Overloaded Hemodialysis Patients (BVM-Reg)

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. Identifier: NCT01416753
Recruitment Status : Completed
First Posted : August 15, 2011
Last Update Posted : September 3, 2012
Information provided by (Responsible Party):
Marcus Saemann, Medical University of Vienna

Brief Summary:

Background: Data generated with the body composition monitor (BCM, Fresenius) show based on bioimpedance technology, that chronic fluid overload in hemodialysis patients is associated with poor survival. However, removing excess fluid by lowering dry weight can be accompanied by intradialytic and postdialytic complications. Here, we aim at testing the hypothesis that, in comparison to conventional hemodialysis, blood-volume monitored regulation of ultrafiltration and dialysate conductivity (UCR) and/or regulation of ultrafiltration and temperature (UTR) will decrease complications when ultrafiltration volumes are systematically increased in fluid overloaded hemodialysis patients.

Methods/Design: BCM-measurements yield results on fluid overload (in liters), relative to extracellular water (ECW). In this prospective, multicenter, triple-arm, parallel group, cross-over, randomized, controlled clinical trial, we use BCM-measurements, routinely introduced in our 3 maintenance hemodialysis centers shortly prior to the start of the study, to recruit 60 hemodialysis patients with fluid overload (defined as ≥15% ECW). Patients are randomized 1:1:1 into UCR, UTR and conventional hemodialysis groups. BCM-determined, 'final' dry weight is set as -7% ECW postdialysis, and reached by reducing the previous dry weight, in steps of 0.1 kg per 10 kg body weight, during 12 hemodialysis sessions (one study phase). In case of intradialytic complications, dry weight reduction is decreased, according to a pre-specified algorithm. A comparison of intra- and postdialytic complications among study groups constitutes the primary endpoint. In addition, we will assess relative weight reduction, changes in residual renal function, quality of life measures, and predialysis levels of various laboratory parameters including C-reactive protein, troponin T, and N-terminal pro-B-type natriuretic peptide, before and after the first study phase (secondary outcome parameters).

Discussion: Patients are not requested to revert to their initial degree of fluid overload after each study phase, Therefore, the cross-over design of the present study merely serves the purpose of secondary end-point evaluation, for example to determine patient choice of treatment modality. Previous studies on blood volume monitoring have yielded inconsistent results. Since we include only patients with BCM-determined fluid overload, we expect a benefit for all study participants, due to strict fluid management which decreases the mortality risk of hemodialysis patients.

Condition or disease Intervention/treatment Phase
Overhydration Dry Weight Reduction Device: UCR Device: UTR Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Clinical Trial Comparing, in Fluid-Overloaded Hemodialysis Patients, Three Strategies of Fluid Removal: Regulation of Ultrafiltration and Dialysate Conductivity, Regulation of Ultrafiltration and Temperature, and Standard Hemodialysis
Study Start Date : September 2011
Actual Primary Completion Date : August 2012
Actual Study Completion Date : August 2012

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: UCR
regulation of ultrafiltration and conductivity
Device: UCR
BVM-based regulation of ultrafiltration and conductivity

Active Comparator: UTR
regulation of ultrafiltration and temperature
Device: UTR
BVM-based regulation of ultrafiltration; regulation of temperature

No Intervention: conventional dialysis
dry weight reduction without BVM

Primary Outcome Measures :
  1. The primary outcome measure is the number of intradialytic complications in each of the three study groups, only during the first study phase. [ Time Frame: 4 weeks for one study phase ]
    The study sample will consist of 60 patients with ECV ≥15%, by BCM-measurement. For the primary endpoint analysis, we will assess the differences in intradialytic complications between the three study groups, only during the first study phase. The UCR and UTR groups will be tested against the conventional HD control group, and afterwards against one another.

Secondary Outcome Measures :
  1. (see detailed description listed above, under primary objectives) [ Time Frame: (as above) ]
    (as above)

Information from the National Library of Medicine

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

Inclusion Criteria:

  • HD >3 months
  • Fluid overload ≥15% of extracellular volume (ECV) predialysis, as determined by BCM-measurement, after one of the 2 the midweek interdialytic intervals
  • Informed consent of the patient

Exclusion Criteria:

  • none, except those specified by the Declaration of Helsinki

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 identifier (NCT number): NCT01416753

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Medical University of Vienna
Vienna, Austria, 1090
Sponsors and Collaborators
Marcus Saemann
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Principal Investigator: Marcus D Säemann, MD Medical University of Vienna, Austria, 1090 Vienna
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Marcus Saemann, Ass. Prof. Dr. Marcus Säemann, Medical University of Vienna Identifier: NCT01416753    
Other Study ID Numbers: EK.-Nr. 365/2011
First Posted: August 15, 2011    Key Record Dates
Last Update Posted: September 3, 2012
Last Verified: August 2012
Keywords provided by Marcus Saemann, Medical University of Vienna:
blood volume monitoring
Additional relevant MeSH terms:
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Weight Loss
Body Weight Changes
Body Weight