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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000024670
Receipt No. 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

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Basic information
Public title Evaluation of ultrafiltration control using blood volume monitor during hemodialysis
Acronym UF control using BVM during HD
Scientific Title Evaluation of ultrafiltration control using blood volume monitor during hemodialysis
Scientific Title:Acronym UF control using BVM during HD
Region
Japan

Condition
Condition maintenance hemodialysis
Classification by specialty
Nephrology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 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.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Occurrence of intradialytic hypotensin
Key secondary outcomes Management necessity to intradialytic hypotension
Change of vlood volume after HD
Change of blood pressure during HD
Achievement of targeted fluid-management after HD

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 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
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 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.
Key exclusion criteria 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.
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Susumu Ookawara
Organization Saitama Medical Center, Jichi Medical University
Division name First department of Integrated Medicine
Zip code
Address 1-847 Amanuma-cho, Omiya-ku, Saitama-City, Saitama
TEL 048-647-2111
Email ookawaras@jichi.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Susumu Ookawara
Organization Saitama Medical Center, Jichi Medical University
Division name First department of Integrated Medicine
Zip code
Address 1-847 Amanuma-cho, Omiya-ku, Saitama-City, Saitama
TEL 048-647-2111
Homepage URL
Email ookawaras@jichi.ac.jp

Sponsor
Institute Division of Nephrology, First Department of Integrated Medicine, Jichi Medical University
Institute
Department

Funding Source
Organization Nikiso Corporation, Tokyo, Japan
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2016 Year 12 Month 01 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2016 Year 09 Month 28 Day
Date of IRB
Anticipated trial start date
2016 Year 12 Month 01 Day
Last follow-up date
2017 Year 09 Month 30 Day
Date of closure to data entry
Date trial data considered complete
2017 Year 10 Month 01 Day
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 11 Month 01 Day
Last modified on
2017 Year 11 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028372

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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