UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Evaluation of ultrafiltration control using blood volume monitor during hemodialysis
Title of the study (Brief title)	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	Susumu Ookawara
Organization	Saitama Medical Center, Jichi Medical University
Division name	First department of Integrated Medicine
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	Susumu Ookawara
Organization	Saitama Medical Center, Jichi Medical University
Division name	First department of Integrated Medicine
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 09 Month 28 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000028372