Unique ID issued by UMIN | UMIN000024670 |
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Receipt number | R000028372 |
Scientific Title | Evaluation of ultrafiltration control using blood volume monitor during hemodialysis |
Date of disclosure of the study information | 2016/12/01 |
Last modified on | 2017/11/29 12:29:53 |
Evaluation of ultrafiltration control using blood volume monitor during hemodialysis
UF control using BVM during HD
Evaluation of ultrafiltration control using blood volume monitor during hemodialysis
UF control using BVM during HD
Japan |
maintenance hemodialysis
Nephrology |
Others
NO
We compare the occurrence of intradialytic hypotension between hemodialysis (HD) therapies based on a ultrafiltration control of blood volume (BV-UFC) using blood volume monitor (BVM) and those with constant ultrafiltration in this study, and aims to confirm the safety of fluid-balance management during HD under the use of BV-UFC as well as the safety of conventional HD therapy.
Safety
Occurrence of intradialytic hypotensin
Management necessity to intradialytic hypotension
Change of vlood volume after HD
Change of blood pressure during HD
Achievement of targeted fluid-management after HD
Interventional
Single arm
Non-randomized
Open -no one is blinded
Self control
1
Treatment
Device,equipment |
Evaluation period: 8 weeks
Methods:
In each included HD patient, conventional HD and HD under the use of BV-UFC by BVM are performed, which are also crossed at 1st and 2nd HD day in each week, for 8 weeks. 3rd HD therapy are excluded in the analysis of this study.
Study schedule (weekly)
(period) 1st HD 2nd 3rd
1st week conventional BV-UFC conventional
2nd week BV-UFC conventional BV-UFC
3rd week conventional BV-UFC conventional
4th week BV-UFC conventional BV-UFC
...
8th week BV-UFC conventional BV-UFC
conventional HD: HD therapy with constant ultrafiltration.
BV-UFC: HD therapy with BV-UFC using BVM
20 | years-old | <= |
Not applicable |
Male and Female
patients undergoing HD.
HD duration is more than 3 months with stable condition.
Patients with hemoconcentration after HD compared with before HD.
Serum albumin concentration is more than 3.0 g/dL.
HD session is 4 hour.
below age of 20 years.
patients who are impossible to perform self-judgement.
patients with body weight gain less than 1.0 kg.
patients who take anti-hypertensive or anti-hypotensive medicine from one hour before HD to HD procedure.
patients with frequent postural changes during HD.
patients with a suspicion of vascular access resirculation.
patients with old myocardial infarction.
patients with angina pectoris.
patients with severe cardiovascular diseases.
patients with pregnancy or a possibility of pregnancy.
patients who are thought inadequate by doctor.
60
1st name | |
Middle name | |
Last name | Susumu Ookawara |
Saitama Medical Center, Jichi Medical University
First department of Integrated Medicine
1-847 Amanuma-cho, Omiya-ku, Saitama-City, Saitama
048-647-2111
ookawaras@jichi.ac.jp
1st name | |
Middle name | |
Last name | Susumu Ookawara |
Saitama Medical Center, Jichi Medical University
First department of Integrated Medicine
1-847 Amanuma-cho, Omiya-ku, Saitama-City, Saitama
048-647-2111
ookawaras@jichi.ac.jp
Division of Nephrology, First Department of Integrated Medicine, Jichi Medical University
Nikiso Corporation, Tokyo, Japan
Profit organization
NO
2016 | Year | 12 | Month | 01 | Day |
Unpublished
Completed
2016 | Year | 09 | Month | 28 | Day |
2016 | Year | 12 | Month | 01 | Day |
2017 | Year | 09 | Month | 30 | Day |
2017 | Year | 10 | Month | 01 | Day |
2016 | Year | 11 | Month | 01 | Day |
2017 | Year | 11 | Month | 29 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028372
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