Blood volume-monitored regulation of ultrafiltration in fluid-overloaded hemodialysis patients: study protocol for a randomized controlled trial

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.

doi:10.1186/1745-6215-13-79

Cited by 16 publications

(24 citation statements)

References 59 publications

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“…The principles of the dialysis techniques under investigation (UCR and UTR), compared to the standard (CONV), have been thoroughly discussed [18]. Briefly, with blood volume monitoring, ultrafiltration rates are variable and constantly adapted during the hemodialysis session.…”

Section: Methodsmentioning

confidence: 99%

Blood volume-monitored regulation of ultrafiltration to decrease the dry weight in fluid-overloaded hemodialysis patients: a randomized controlled trial

Antlanger

Josten²,

Kammer

et al. 2017

BMC Nephrol

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BackgroundBecause chronic fluid volume overload is associated with higher mortality, we tested whether blood-volume monitored regulation of ultrafiltration and dialysate conductivity (UCR) and/or regulation of ultrafiltration and temperature (UTR) would facilitate dry weight reduction, in comparison to conventional dialysis (CONV).MethodsWe carried out a multicenter, 4-week, randomized controlled trial in hemodialysis patients ≥15% above normal extracellular fluid volume (ECV), per bioimpedance spectroscopy, who were randomized 1:1:1. Applying UCR (Nikkiso), UTR (Fresenius) and CONV, initial dry weight was reduced rapidly to target. Dry weight reduction was attenuated and eventually stopped at the occurrence of dialysis complications. The primary outcome was defined as intra- and postdialytic complications. Secondary outcomes were magnitudes of dry weight and blood pressure reduction.ResultsOf 244 patients assessed, N = 95 had volume overload ≥15% above normal ECV. Fifty patients received the allocated interventions (N = 16 UCR, N = 18 UTR, N = 16 CONV) and completed the trial. The rate of complications was significantly lower in UTR compared to CONV (21 ± 21% vs 34 ± 20%, p = 0.022), and also compared to UCR (vs 39 ± 27%, p = 0.028), but not statistically different between UCR and CONV (p = 0.93). Dry weight reduction was significantly higher in UTR compared to UCR (5.0 ± 3.4% vs 2.0 ± 2.7% body weight, p = 0.013), but not compared to CONV (vs 3.9 ± 2.1% body weight, p = 0.31). Systolic blood pressure reduction throughout the intervention phase was 17 ± 22 mmHg overall, but not significantly different between the three groups. Average maximum ultrafiltration rates were significantly higher in UTR than in UCR and CONV, at statistically similar dialysis times. Retrospective examination of randomly selected hemodialysis sessions in the UCR group identified technical mistakes in 36% of the dialysis sessions, despite considerable training efforts.ConclusionsEven in patients with volume overload, fluid removal was challenging. Despite the relative advantage of UTR, which must be interpreted with caution in view of the poor technical execution of UCR, this study renders clear that fluid removal must not be reinforced rapidly. Apprehension of this obstacle is imperative for future clinical and academic endeavors aimed at improving dialysis outcomes by correcting volume status.Trial registration ClinicalTrials.gov (NCT01416753), trial registration date: August 12, 2011.

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Section: Methodsmentioning

confidence: 99%

Blood volume-monitored regulation of ultrafiltration to decrease the dry weight in fluid-overloaded hemodialysis patients: a randomized controlled trial

Antlanger

Josten²,

Kammer

et al. 2017

BMC Nephrol

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“…Recently completed, controlled studies have been testing prospectively if regulated ultrafiltration may assist rapid removal of volume overload [125] and whether an improved volume status improves the cardiac condition [126]. The results of these studies will prove useful for a trial aimed at improving outcomes in HD patients.…”

Section: Perspectivesmentioning

confidence: 99%

Significance of Interdialytic Weight Gain versus Chronic Volume Overload: Consensus Opinion

et al. 2013

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Predialysis volume overload is the sum of interdialytic weight gain (IDWG) and residual postdialysis volume overload. It results mostly from failure to achieve an adequate volume status at the end of the dialysis session. Recent developments in bioimpedance spectroscopy and possibly relative plasma volume monitoring permit noninvasive volume status assessment in hemodialysis patients. A large proportion of patients have previously been shown to be chronically volume overloaded predialysis (defined as >15% above ‘normal' extracellular fluid volume, equivalent to >2.5 liters on average), and to exhibit a more than twofold increased mortality risk. By contrast, the magnitude of the mortality risk associated with IDWG is much smaller and only evident with very large weight gains. Here we review the available evidence on volume overload and IDWG, and question the use of IDWG as an indicator of ‘nonadherence' by describing its association with postdialysis volume depletion. We also demonstrate the relationship between IDWG, volume overload and predialysis serum sodium concentration, and comment on salt intake. Discriminating between volume overload and IDWG will likely lead to a more appropriate management of fluid withdrawal during dialysis. Consensually, the present authors agree that this discrimination should be among the primary goals for dialysis caretakers today. In consequence, we recommend objective measures of volume status beyond mere evaluations of IDWG.

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“…All three institutions subsequently participated in the ‘BVM-Reg’ study on dry-weight reduction [28], which investigated whether blood volume monitoring (BVM)-adjusted ultrafiltration rates might reduce intradialytic symptoms associated with a rapid ultrafiltration process in fluid overloaded hemodialysis patients [29,30]. …”

Section: Introductionmentioning

confidence: 99%

Fluid overload in hemodialysis patients: a cross-sectional study to determine its association with cardiac biomarkers and nutritional status

et al. 2013

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BackgroundChronic fluid overload is associated with higher mortality in dialysis patients; however, the link with cardiovascular morbidity has not formally been established and may be influenced by subclinical inflammation. We hypothesized that a relationship exists between fluid overload and [i] cardiovascular laboratory parameter as well as between fluid overload and [ii] inflammatory laboratory parameters. In addition, we aimed to confirm whether volume status correlates with nutritional status.MethodsWe recorded baseline characteristics of 244 hemodialysis patients at three hemodialysis facilities in Vienna (Austria) and determined associations with volume measurements using the body composition monitor (Fresenius/Germany). In one facility comprising 126 patients, we further analyzed cardiovascular, inflammatory and nutritional parameters.ResultsWe detected predialysis fluid overload (FO) in 39% of all patients (n = 95) with FO defined as ≥15% of extracellular water (ECW). In this subgroup, the absolute FO was 4.4 +/-1.5 L or 22.9 ± 4.8% of ECW. A sub-analysis of patients from one center showed that FO was negatively associated with body mass index (r = -0.371; p = <0.001), while serum albumin was significantly lower in fluid overloaded patients (p = 0.001). FO was positively associated with D-Dimer (r = 0.316; p = 0.001), troponin T (r = 0.325; p < 0.001), and N-terminal pro-B-type natriuretic peptide (r = 0.436; p < 0.001), but not with investigated inflammatory parameters.ConclusionsFluid overload in HD patients was found to be lower in patients with high body mass index, indicating that dry weight was inadequately prescribed and/or difficult to achieve in overweight patients. The association with parameters of cardiovascular compromise and/or damage suggests that fluid overload is a biomarker for cardiovascular risk. Future studies should determine if this applies to patients prior to end-stage renal disease.

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Blood volume-monitored regulation of ultrafiltration in fluid-overloaded hemodialysis patients: study protocol for a randomized controlled trial

Cited by 16 publications

References 59 publications

Blood volume-monitored regulation of ultrafiltration to decrease the dry weight in fluid-overloaded hemodialysis patients: a randomized controlled trial

Blood volume-monitored regulation of ultrafiltration to decrease the dry weight in fluid-overloaded hemodialysis patients: a randomized controlled trial

Significance of Interdialytic Weight Gain versus Chronic Volume Overload: Consensus Opinion

Fluid overload in hemodialysis patients: a cross-sectional study to determine its association with cardiac biomarkers and nutritional status

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