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 syste...
| Main Authors: | , , , , , , , |
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| Format: | Article |
| Language: | English |
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BMC
2018-02-01
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| Series: | Renal Replacement Therapy |
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| Online Access: | http://link.springer.com/article/10.1186/s41100-018-0151-1 |
| _version_ | 1818155674799964160 |
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| author | Takashi Shigematsu Jun Minakuchi Satoshi Funakoshi Junichiro Hashiguchi Hiroshi Yoshimoto Kyoko Ito Takuya Ban Tetsunosuke Kunitomo |
| author_facet | Takashi Shigematsu Jun Minakuchi Satoshi Funakoshi Junichiro Hashiguchi Hiroshi Yoshimoto Kyoko Ito Takuya Ban Tetsunosuke Kunitomo |
| author_sort | Takashi Shigematsu |
| collection | DOAJ |
| description | 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. (This Clinical Trial No. is 21500BZZ00045000) |
| first_indexed | 2024-12-11T14:46:10Z |
| format | Article |
| id | doaj.art-5440aeae18054f0ca8c626b137bdfb0d |
| institution | Directory Open Access Journal |
| issn | 2059-1381 |
| language | English |
| last_indexed | 2024-12-11T14:46:10Z |
| publishDate | 2018-02-01 |
| publisher | BMC |
| record_format | Article |
| series | Renal Replacement Therapy |
| spelling | doaj.art-5440aeae18054f0ca8c626b137bdfb0d2022-12-22T01:01:41ZengBMCRenal Replacement Therapy2059-13812018-02-01411810.1186/s41100-018-0151-1Clinical evaluation of a newly developed automated hemodialysis system as a clinical trialTakashi Shigematsu0Jun Minakuchi1Satoshi Funakoshi2Junichiro Hashiguchi3Hiroshi Yoshimoto4Kyoko Ito5Takuya Ban6Tetsunosuke Kunitomo7Department of Nephrology, Wakayama Medical UniversityDepartment of Nephrology and Blood Purification, Kawashima HospitalDepartment of Nephrology and Blood Purification, Nagasaki Jin HospitalDepartment of Blood Purification, Nagasaki Jin ClinicDivision of Nephrology and Dialysis, Department of Medicine, Social Insurance Chuo General HospitalDepartment of Blood Purification, Heisei Hidaka ClinicToray Medical Co., Ltd.Toray Medical Co., Ltd.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. (This Clinical Trial No. is 21500BZZ00045000)http://link.springer.com/article/10.1186/s41100-018-0151-1HemodialysisAutomated systemClinical trialUltrafiltrated dialysateEndotoxin retentive filter |
| spellingShingle | Takashi Shigematsu Jun Minakuchi Satoshi Funakoshi Junichiro Hashiguchi Hiroshi Yoshimoto Kyoko Ito Takuya Ban Tetsunosuke Kunitomo Clinical evaluation of a newly developed automated hemodialysis system as a clinical trial Renal Replacement Therapy Hemodialysis Automated system Clinical trial Ultrafiltrated dialysate Endotoxin retentive filter |
| title | Clinical evaluation of a newly developed automated hemodialysis system as a clinical trial |
| title_full | Clinical evaluation of a newly developed automated hemodialysis system as a clinical trial |
| title_fullStr | Clinical evaluation of a newly developed automated hemodialysis system as a clinical trial |
| title_full_unstemmed | Clinical evaluation of a newly developed automated hemodialysis system as a clinical trial |
| title_short | Clinical evaluation of a newly developed automated hemodialysis system as a clinical trial |
| title_sort | clinical evaluation of a newly developed automated hemodialysis system as a clinical trial |
| topic | Hemodialysis Automated system Clinical trial Ultrafiltrated dialysate Endotoxin retentive filter |
| url | http://link.springer.com/article/10.1186/s41100-018-0151-1 |
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