A novel pump-free ultrafiltration rate modulation system for continuous renal replacement therapy applications

Purpose: Extracorporeal ultrafiltration is an attractive alternative to diuretics for removing excess plasma water in critically ill patients suffering from fluid overload. In continuous renal replacement therapy (CRRT), ultrafiltration occurs in isolated form (SCUF) or supplemented by replacement fluid infusion (CVVH) and the net fluid removal rate is controlled by peristaltic pumps. In this work, a pump-free solution for regulating the ultrafiltration rate in CRRT applications is presented. Methods: The system consists of a motorized clamp on the ultrafiltration line, whose intermittent opening is modulated with a closed-loop control system based on monitoring of ultrafiltrate collected and any replacement fluid infused. The system was tested on two platforms for SCUF and CVVH, with “low-flux” and “high-flux” hemofilter, with various ultrafiltration setpoints and patient net weight loss targets. Results: In all configurations the set ultrafiltration rate was achieved with a maximum error of 5% and the values recorded were kept within ± 100 ml/h with respect to the setpoint, as recommended by international standard IEC 60601-2-16. The net fluid removal trend was highly correlated with that expected (95%<99%) and the weight loss target was reached in the expected time. For low ultrafiltration rates (60-150 ml/h) the system accuracy was better with the “low-flux” hemofilter. Conclusion: The developed clamp system represents a valid alternative to state-of-the-art solutions with peristaltic pumps in terms of performance, with potential usability advantages. The compliance with safety requirements given by international standard IEC 60601-2-16 is a prerequisite for clinical use.