Response Options to Blood Volume Monitoring in Fluid Overloaded Hemodialysis Patients

NCT01416753 | Completed

• 1 other identifier: EK.-Nr. 365/2011
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

Overhydration; Dry Weight Reduction

Keywords

hemodialysis; blood volume monitoring

Outcome Measures

Primary Outcomes (1)

• The primary outcome measure is the number of intradialytic complications in each of the three study groups, only during the first 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.

  4 weeks for one study phase

Secondary Outcomes (1)

• (see detailed description listed above, under primary objectives)

  (as above)

Study Arms (3)

UCR

ACTIVE COMPARATOR

regulation of ultrafiltration and conductivity

Device: UCR

UTR

ACTIVE COMPARATOR

regulation of ultrafiltration and temperature

Device: UTR

conventional dialysis

NO INTERVENTION

dry weight reduction without BVM

Interventions

UCR DEVICE

BVM-based regulation of ultrafiltration and conductivity

UCR

UTR DEVICE

BVM-based regulation of ultrafiltration; regulation of temperature

UTR

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• none, except those specified by the Declaration of Helsinki

Sponsors & Collaborators

• Marcus Saemann: lead

Study Sites (1)

Medical University of Vienna

Vienna, 1090, Austria

Location

Related Publications (2)

• Antlanger M, Josten P, Kammer M, Exner I, Lorenz-Turnheim K, Eigner M, Paul G, Klauser-Braun R, Sunder-Plassmann G, Saemann MD, Hecking M. Blood volume-monitored regulation of ultrafiltration to decrease the dry weight in fluid-overloaded hemodialysis patients: a randomized controlled trial. BMC Nephrol. 2017 Jul 17;18(1):238. doi: 10.1186/s12882-017-0639-x.

  PMID: 28716046 DERIVED

• Hecking M, Antlanger M, Winnicki W, Reiter T, Werzowa J, Haidinger M, Weichhart T, Polaschegg HD, Josten P, Exner I, Lorenz-Turnheim K, Eigner M, Paul G, Klauser-Braun R, Horl WH, Sunder-Plassmann G, Saemann MD. Blood volume-monitored regulation of ultrafiltration in fluid-overloaded hemodialysis patients: study protocol for a randomized controlled trial. Trials. 2012 Jun 8;13:79. doi: 10.1186/1745-6215-13-79.

  PMID: 22682149 DERIVED

MeSH Terms

Conditions

Water Intoxication

Condition Hierarchy (Ancestors)

Water-Electrolyte Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases; Poisoning; Chemically-Induced Disorders

Study Officials

• Marcus D Säemann, MD

  Medical University of Vienna, Austria, 1090 Vienna

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Ass. Prof. Dr. Marcus Säemann

Study Record Dates

• First Submitted: August 12, 2011
• First Posted: August 15, 2011
• Study Start: September 1, 2011
• Primary Completion: August 1, 2012
• Study Completion: August 1, 2012
• Last Updated: September 3, 2012

Record last verified: 2012-08

Locations

AU (1)