A Novel Ultrafiltration Rate Feedback Controller for Use in Hemodialysis First Clinical Experience: First Clinical Experience: An Interventional Pilot Study.

Abstract

Background: Relative blood volume (RBV) monitors are increasingly being used during hemodialysis. Manual ultrafiltration rate (UFR) adjustments to establish a favorable RBV trajectory are not feasible in routine practice. The goal of this study was to characterize the behavior of a new UFR feedback controller in vivo.

Methods: In this pilot trial, chronic hemodialysis patients were prospectively studied during up to six successful study dialysis treatments each. During each study visit, the feedback controller generated UFR recommendations designed to guide the subject's RBV curve towards a pre-defined target trajectory. Each recommendation was evaluated by licensed healthcare staff and then either implemented or disregarded. Results were compared to standard-of-care treatments in the same subjects.

Results: Fifteen subjects (age 59 ± 15 years, 8 males) were studied during a total of 63 treatments. The controller functioned as intended and issued a total of 1 037 recommendations. Compared to standard-of-care treatments, its use was associated with a higher probability of RBV target range attainment (69% vs. 47%) and lower nadir systolic (106 vs. 111 mmHg) and diastolic (55 vs. 59 mmHg) blood pressure.

Conclusions: The UFR feedback controller operated as intended, and its use led to a substantial increase in the rate of RBV target range attainment. This technology holds promise for improving fluid management in chronic hemodialysis patients.