Effect of ultrafiltration profiling on outcomes among maintenance hemodialysis patients: a pilot randomized crossover trial

Abstract

Background: More rapid fluid removal during hemodialysis is associated with adverse cardiovascular outcomes and longer dialysis recovery times. The effect of ultrafiltration (UF) profiling, independent of concomitant sodium profiling, on markers of intradialytic hemodynamics and other outcomes has been inadequately studied.

Methods: Four-phase, blinded crossover trial. Participants (UF rates > 10 mL/h/kg) were assigned in random order to receive hemodialysis with UF profiling (constantly declining UF rate, intervention) vs. hemodialysis with conventional UF (control). Each 3-week 9-treatment period was followed by a 1-week 3-treatment washout period. Participants crossed into each study arm twice (2 phases/arm); 18 treatments per treatment type. The primary outcomes were intradialytic hypotension, pre- to post-dialysis troponin T change, and change from baseline in left ventricular global longitudinal strain. Other outcomes included intradialytic symptoms and blood volume measured-plasma refill (post-dialysis volume status measure), among others. Each participant served as their own control.

Results: On average, the 34 randomized patients (mean age 56 years, 24% female, mean dialysis vintage 6.3 years) had UF rates > 10 mL/h/kg in 56% of treatments during the screening period. All but 2 patients completed the 15-week study (prolonged hospitalization, kidney transplant). There was no significant difference in intradialytic hypotension, troponin T change, or left ventricular strain between hemodialysis with UF profiling and conventional UF. With UF profiling, participants had significantly lower odds of light-headedness and plasma refill compared to hemodialysis with conventional UF.

Conclusions: Ultrafiltration (UF) profiling did not reduce the odds of treatment-related cardiac stress but did reduce the odds of light-headedness and post-dialysis hypervolemia.

Trial registration: Clinicaltrials.gov identifier: NCT03301740 (registered October 4, 2017).

Keywords: Blood pressure; Cardiovascular; Clinical trial; Echocardiogram; Hemodialysis; Hypotension; Symptoms; Ultrafiltration.

Conflict of interest statement

Conflicts of interest/Competing interests: In the last 3 years, JEF has received speaking honoraria from American Renal Associates, the American Society of Nephrology, Dialysis Clinic, Inc., the National Kidney Foundation, and multiple universities. JEF is on the medical advisory board of NxStage Medical, Inc. and has received consulting fees from Fresenius Medical Care, North America, and AstraZeneca. In the last 3 years, MMA has received investigator-initiated research funding from the Renal Research Institute, a subsidiary of Fresenius Medical Care, North America, and honoraria from the International Society of Nephrology. The remaining authors have no competing interests.

Figures

Figure 1.

Study design. Study eligibility was determined in a 4-week screening period which was followed by a 6-week baseline data collection period. Participants were then randomized to either hemodialysis with profiled UF or hemodialysis with conventional UF for their first 9-treatment study period, followed by a 3-treatment washout period. Participants then crossed over to the other study arm for a 9-treatment phase and 3-treatment washout period. The same sequence was then repeated such that each patient underwent 2 phases of hemodialysis with UF profiling (18 treatments total), 2 phases of hemodialysis with conventional UF (18 treatments total), and 3 washout periods (9 treatments total). Abbreviations: UF, ultrafiltration; w-o, washout.

Figure 2.

Participant flow diagram. Abbreviations: UF, ultrafiltration.

Figure 3.

Change in left ventricular systolic and diastolic function from baseline to peak intradialytic stress with UF profiling vs. conventional UF. Comparison of change in left ventricular GLS (%) and E/e’ from baseline to peak intradialytic stress with hemodialysis with UF profiling compared to hemodialysis with conventional UF. A greater positive change from 0 for left ventricular GLS indicates greater left ventricular systolic function impairment with dialysis. A greater positive change from 0 for E/e’ indicates greater left ventricular diastolic function impairment with dialysis. Baseline TTEs were performed on a non-dialysis day. Intradialytic TTEs were performed 30 minutes before the end of hemodialysis during a hemodialysis treatment following the 72-hour break. Abbreviations: E/e’, early mitral inflow velocity/mitral annular early diastolic velocity; GLS, global longitudinal strain; LV, left ventricular; UF, ultrafiltration.