Randomized Crossover Trial of Blood Volume Monitoring-Guided Ultrafiltration Biofeedback to Reduce Intradialytic Hypotensive Episodes with Hemodialysis

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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