Studying the benefits of hemodiafiltration

A project launched by the Vanderbilt University School of Medicine’s Nephrology Division is currently evaluating the impact of online-hemodiafiltration on dialysis clinic operations, while beginning to explore if enhanced convective clearance improves patient care among treated individuals with end-stage renal disease. NN&I asked Jamie P. Dwyer, MD, Professor of Medicine, Medical Director of the Vanderbilt East Dialysis Clinic (where the project is occurring) and Director of the Nephrology Clinical Trials Center, and Edward R. Gould, MD, Assistant Professor of Medicine and Director of ESRD Quality—about the quality improvement initiative’s intent and progress to date.

NN&I: What were the perceived benefits that you felt online-hemodiafiltration could offer?

Jamie Dwyer, MD: Experience with online-hemodiafiltration systems in the US is incredibly limited. The European dialysis market has adopted online-hemodiafiltration more widely. Their data suggests there may be improved patient outcomes with its use, presumably due to enhanced molecular clearance.

Our goal was to explore the operational impact of hemodiafiltration use, and to begin to understand whether our patient population would see similar benefits to those observed in the European cohorts.

NN&I: How did that relationship translate into this exploratory initiative?

Edward R. Gould, MD: Vanderbilt Nephrology has a long history of performing cutting edge basic, translational, and clinical investigation, as well as in dialysis delivery. We have been involved in early work on dialysis intensity, high-flux dialysis membrane use, frequent hemodialysis, and in exploring the impact of nocturnal dialysis. Nephros offers the on-line OLpur H2H Hemodiafiltration System, and we ultimately decided this project was worth pursuing.

We began to work on addressing the operational barriers to device use. This meant ensuring that our water system was up to the task of providing ultrapure dialysate, that critical building infrastructure could accommodate a second freestanding device at each station, and that the workload on dialysis technicians and nurses would remain balanced across the clinic.

OLpur MD 220 Hemodiafilter provides mid-dilution hemodiafiltration with its two-port cap, two-staged design, and distal infusion port allowing substitution fluid to be infused between the two stages

NN&I: How is the Vanderbilt Division of Nephrology connected to Nephros?

JD: Some of the Vanderbilt faculty had previous connections with Nephros and were approached about being involved in a hemodiafiltration project.

NN&I: How did you select the patients that would be involved in the initial phase?

JD: We knew that our first phase would include four hemodiafiltration devices, and that we would start including patients in a step-wise fashion to allow for the clinic staff to adjust to the introduction. The patients that were chosen were those who were not actively involved in ongoing clinical trials, who expressed interest in the device and its potential benefits, and who had more flexible schedules—given concern for operational changes that might impact treatment start-time and end-time. To date, we have begun treatment of nine patients, but expect to expand operations to include 16 patients by the end of Q2 2017.

NN&I: Can you report on any results yet from this project?

EG: Given our very small patient cohort to date and the rolling initiation dates, it is still too early to tell if there is any difference in patient reported outcomes or in laboratory metrics. Once we feel we have an adequate number of involved patients, we plan to compare their clinical and laboratory values (KDQOL scores, BP control, bone-mineral metrics, hemoglobin, ESA dose, etc.) to pre-treatment values searching for improvements. We also plan to explore the workload imposed by device introduction on both the clinic and staff in order to better evaluate the impact of adding a second freestanding device to the dialysis station.