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

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. Conclusions: This study confirmed the safety and effectiveness of an automated HD system based on CDDS.

Efficacy and Safety of Modified Polyethersulfone Hemodialysis Filters in Comparison to Conventional Filters: A Non-inferiority Clinical Trial

“…In this study, blinding for the physician, patients, and nurses responsible for inserting the filter and measuring the factors related to dialysis adequacy could not be performed; nevertheless, the person responsible for analyzing the data was not aware of the filter type received by each patient. A study conducted by Shigematsu et al was used to determine the sample size (11). Group A was put on HD for 2 weeks (six sessions of HD) at first with low or high flux smart flux filter (m-PES-1.5 hollow fiber), which was made in Italy by Medica S.P.A. Group (Mahan Med Mayme Kish Company, Iran) with a surface size of 1.5 m 2 .…”