Blood volume-monitored regulation of ultrafiltration in fluid-overloaded hemodialysis patients: study protocol for a randomized controlled trial
Author:
Hecking Manfred,Antlanger Marlies,Winnicki Wolfgang,Reiter Thomas,Werzowa Johannes,Haidinger Michael,Weichhart Thomas,Polaschegg Hans-Dietrich,Josten Peter,Exner Isabella,Lorenz-Turnheim Katharina,Eigner Manfred,Paul Gernot,Klauser-Braun Renate,Hörl Walter H,Sunder-Plassmann Gere,Säemann Marcus D
Abstract
Abstract
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, crossover, randomized, controlled clinical trial, we use BCM measurements, routinely introduced in our three maintenance hemodialysis centers shortly prior to the start of the study, to recruit sixty 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 to normohydration weight −7% of 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 prespecified algorithm. A comparison of intra- and post-dialytic 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 crossover design of the present study merely serves the purpose of secondary endpoint 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.
Trial registration
ClinicalTrials.gov, NCT01416753
Publisher
Springer Science and Business Media LLC
Subject
Pharmacology (medical),Medicine (miscellaneous)
Reference71 articles.
1. Scribner BH, Buri R, Caner JE, Hegstrom R, Burnell JM: The treatment of chronic uremia by means of intermittent hemodialysis: a preliminary report. Trans Am Soc Artif Intern Organs. 1960, 6: 114-122. 2. Franz M, Pohanka E, Tribl B, Woloszczuk W, Horl WH: Living on chronic hemodialysis between dryness and fluid overload. Kidney Int Suppl. 1997, 59: S39-42. 3. Wabel P, Chamney P, Moissl U, Jirka T: Importance of whole-body bioimpedance spectroscopy for the management of fluid balance. Blood Purif. 2009, 27: 75-80. 10.1159/000167013. 4. Moissl UM, Wabel P, Chamney PW, Bosaeus I, Levin NW, Bosy-Westphal A, Korth O, Muller MJ, Ellegard L, Malmros V, Kaitwatcharachai C, Kuhlmann MK, Zhu F, Fuller NJ: Body fluid volume determination via body composition spectroscopy in health and disease. Physiol Meas. 2006, 27: 921-933. 10.1088/0967-3334/27/9/012. 5. Moissl U, Bosaeus I, Lemmey A, Hovgesen S, Wabel P, Chamney PW, Bosy-Westphal A, Korth O, Mueller MJ, Renders L, Ellegard L, Malmros V, Fuller NJ: Validation of a 3 C model for determination of body fat mass. J Am Soc Nephrol. 2007, 18: 257A-
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