Clinical evaluation of a newly developed automated hemodialysis system as a clinical trial

Takashi Shigematsu,Kyoko Ito,Tetsunosuke Kunitomo,Junichiro Hashiguchi,Satoshi Funakoshi,Takuya Ban,Hiroshi Yoshimoto,Jun Minakuchi

doi:10.1186/s41100-018-0151-1

Abstract

BackgroundTo cope with the increasing number of patients on long-term hemodialysis (HD), especially those with diabetic nephropathy, we designed a fully automated HD system to decrease staff workload and hence human errors related to HD treatment. In this study, we evaluated this new system as a clinical trial.MethodsBased on a dialysis machine combined with a central dialysate delivery system (CDDS), the new system is characterized by the use of back ultrafiltrated dialysate (BUD) as a substitute fluid for priming, bonus shot and blood return, and the attachment of double endotoxin retentive filters (ETRFs).ResultsThe subjects comprised 61 patients from five HD facilities enrolled in a randomized, open-labeled crossover study after giving written informed consent.A total of 348 HD treatments for 58 of the 61 patients were studied under a protocol designed in accordance with good clinical practice (GCP) guidelines and approved by the respective institutional review boards. No severe adverse effects were observed with either the test or control systems. The incidence of clinical events, including blood pressure decline, residual blood, and error in fluid removal, was not statistically significant in either group. Neither endotoxins nor bacteria were detected in the dialysate passing through the double filters.ConclusionsThis study confirmed the safety and effectiveness of an automated HD system based on CDDS.(This Clinical Trial No. is 21500BZZ00045000)

Highlights

To cope with the increasing number of patients on long-term hemodialysis (HD), especially those with diabetic nephropathy, we designed a fully automated HD system to decrease staff workload and human errors related to HD treatment
The following two points are of particular importance: 1. The proportion of dialysis patients with diabetic nephropathy has been increasing steadily, reaching nearly 45% of patients commencing dialysis and 36.6% of existing patients
We developed a dialysis console using back ultrafiltrated dialysate (BUD), and special features of this device are that rotation of the blood pump is not reversed during blood return to the arterial side and the blood return speed can be controlled while blood return pressure is monitored

Summary

Introduction

To cope with the increasing number of patients on long-term hemodialysis (HD), especially those with diabetic nephropathy, we designed a fully automated HD system to decrease staff workload and human errors related to HD treatment. More than 95% of patients on maintenance dialysis for endstage renal disease (ESRD) in Japan undergo hemodialysis (HD). At the end of 2014, the number of such patients exceeded 320,000. 2. The population of dialysis patients is aging rapidly. The population of dialysis patients is aging rapidly For both men and women, many patients commencing dialysis are between 80 and 84 years old, representing more than 15 and 17% of those commencing dialysis, respectively, with the median age at commencement of initiating dialysis 69.1 years [1, 2].

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Conclusion