Abstract

Abstract Background and Aims Preciado et al. have identified half-hourly relative blood volume (RBV) targets (at 30, 60…180 min) during hemodialysis (HD) that are associated with significantly improved patient survival. Attainment of these RBV targets would necessitate incessant adjustments to the ultrafiltration rate (UFR) by the dialysis nurse, which is logistically not feasible. We developed a novel proportional-integral controller that takes RBV data from the commercially available CLiC® device as an input and provides UFR suggestions to guide the RBV curve into the desired targets. The clinician specifies the desired UF goal and the maximum allowed upward/downward deviation from this goal, and the Controller then optimizes the RBV trajectory within the limits allowed by the clinician’s prescription. The present study is aimed to characterize the behavior of this novel feedback controller. Method We conducted a single-arm, prospective, interventional pilot study in subjects on chronic HD at three Avantus Renal Therapy Dialysis Centers in New York City. Subjects were treated with Fresenius 2008T HD machines. RBV was measured with the CLiC® device. CLiC® and HD machine data were fed into a research laptop running the UFR Feedback Controller software. The UFR recommendations (generated every 10 minutes) were evaluated by dialysis nurses who then either implemented or rejected them as they deemed clinically appropriate. The nurses were instructed to only override Controller recommendations if medically indicated, but not in an attempt to manage the subjects’ RBV trajectories themselves. Results Fifteen subjects (58.9 ± 15.3 years, 33% white, 53% black, dialysis vintage 4.1 ± 2.4 years, baseline interdialytic weight gain 2.6 ± 0.8 L, treatment time 222 ± 28 min) were studied (63 study visits, 4.2 ± 1.9 visits per subject). Of 300 analyzed RBV target timepoints, 63% had RBVs within the desired target range, 33% of the RBVs were above and 4% were below target. Stratified by timepoint, the on-target percentage increased from 37% at 30 min to 73% at 180 min into HD, while the proportion of RBVs above or below target decreased. In subjects with at least 4 complete study visits (N=8), looking at each of their first 4 complete visits, on average 71.8% of subjects were within the desired RBV target at 180 min into HD. The rate of intradialytic morbid events did not appear to be outside of the ordinary. There was no indication of adverse events related to the use of the UFR Feedback Controller. The Figure shows an example study visit where the UFR Feedback Controller modulates the UFR on an ongoing basis throughout the treatment to keep the RBV curve close to the ideal target trajectory (red line, defined by connecting the RBVs associated with the lowest all-cause mortality). Solid black line: RBV curve (left y-axis); dashed black line: UFR (right y-axis); green boxes: half-hourly RBV target ranges associated with improved survival. Conclusion The UFR Feedback Controller behaves as expected, steering the patients’ RBV curves toward the predefined target ranges where possible, while simultaneously guaranteeing that the prescribed fluid removal goal will be achieved. Preciado et al. had reported approx. one third of patients within the favorable RBV target range at 3h into HD. In contrast, while our pilot study was relatively small, with use of our novel UFR Feedback Controller, approx. 72% of subjects were within the desired RBV target range at 3h into HD. This novel UFR feedback control technology holds great promise for improving fluid management and clinical outcomes in HD patients without requiring additional staff time.

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