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

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

Renal Replacement Therapy20184:9

https://doi.org/10.1186/s41100-018-0151-1

Received: 5 January 2017

Accepted: 25 January 2018

Published: 9 February 2018

Abstract

Background

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 hence human errors related to HD treatment. In this study, we evaluated this new system as a clinical trial.

Methods

Based 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).

Results

The 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.