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

ABSTRACT: Because 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).We 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.Of 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.Even 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.ClinicalTrials.gov ( NCT01416753 ), trial registration date: August 12, 2011.

SUBMITTER: Antlanger M

PROVIDER: S-EPMC5513315 | biostudies-literature | 2017 Jul

REPOSITORIES: biostudies-literature

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

Antlanger Marlies M Josten Peter P Kammer Michael M Exner Isabella I Lorenz-Turnheim Katharina K Eigner Manfred M Paul Gernot G Klauser-Braun Renate R Sunder-Plassmann Gere G Säemann Marcus D MD Hecking Manfred M

BMC nephrology 20170717 1

<h4>Background</h4>Because 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).<h4>Methods</h4>We carried out a multicenter, 4-week, randomized controlled trial in hemodialysis patients ≥15% above normal extracellular fluid volume (ECV), ...[more]

PMID: 28716046

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Project description:BackgroundData 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/designBCM 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).DiscussionPatients 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 registrationClinicalTrials.gov, NCT01416753.

Project description:BACKGROUND AND OBJECTIVES:Intradialytic hypotension (IDH) is associated with morbidity. The effect of blood volume-guided ultrafiltration biofeedback, which automatically adjusts fluid removal rate on the basis of blood volume parameters, on the reduction of IDH was tested in a randomized crossover trial. DESIGN, SETTING, PARTICIPANTS, & MEASUREMENTS:We performed a 22-week, single blind, randomized crossover trial in patients receiving maintenance hemodialysis who had >30% of sessions complicated by symptomatic IDH in five centers in Calgary, Alberta, Canada. Participants underwent a 4-week run-in period to standardize dialysis prescription and dry weight on the basis of clinical examination. Those meeting inclusion criteria were randomized to best clinical practice hemodialysis (control) or best clinical practice plus blood volume-guided ultrafiltration biofeedback (intervention) for 8 weeks, followed by a 2-week washout and subsequent crossover for a second 8-week phase. The primary outcome was rate of symptomatic IDH. RESULTS:Thirty-five participants entered, 32 were randomized, and 26 completed the study. The rate of symptomatic IDH with biofeedback was 0.10/h (95% confidence interval, 0.06 to 0.14) and 0.07/h (95% confidence interval, 0.05 to 0.10) during control (P=0.29). There were no differences in the rate or proportion of sessions with asymptomatic IDH or symptoms alone. Results remained consistent when adjusted for randomization order and study week. There were no differences between intervention and control in the last study week in interdialytic weight gain (difference [SD], -0.02 [0.8] kg), brain natriuretic peptide (1460 [19,052] ng/L), cardiac troponins (3 [86] ng/L), extracellular water-to-intracellular water ratio (0.05 [0.33]), ultrafiltration rate (1.1 [7.0] ml/kg per hour), and dialysis recovery time (0.43 [19.25] hours). CONCLUSION:The use of blood volume monitoring-guided ultrafiltration biofeedback in patients prone to IDH did not reduce the rate of symptomatic IDH events.

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

Publications

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

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