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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000028422
Receipt No. R000032529
Scientific Title Intradialysis body fluid change
Date of disclosure of the study information 2017/08/01
Last modified on 2017/07/28

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Basic information
Public title Intradialysis body fluid change
Acronym HD-BFC
Scientific Title Intradialysis body fluid change
Scientific Title:Acronym HD-BFC
Region
Japan

Condition
Condition Chronic renal failure
Classification by specialty
Nephrology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Identify indicators of intradialysis body fluid change
Basic objectives2 Others
Basic objectives -Others Indicators for hypovolemia
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes hypotensive episode during dialysis
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment No need to know

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 different modality for blood purification
Interventions/Control_2 one session per each modality
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
18 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria patients under maintenance hemodialysis
Key exclusion criteria Unstable hemodynamics during hemodilalysis
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masayuki Tanemoto
Organization Shin-kuki General hospital
Division name Internal medicine
Zip code
Address Kamihayami 418-1, Kuki, Saitama
TEL 81-480-26-0033
Email mtanemoto-tky@umin.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shigeru Takabayashi
Organization Shin-kuki General hospital
Division name General affairs
Zip code
Address Kamihayami 418-1, Kuki, Saitama
TEL 81-480-26-0033
Homepage URL
Email takabayashi@shinkuki-hp.jp

Sponsor
Institute Shin-kuki General hospital
Institute
Department

Funding Source
Organization Shin-kuki General hospital
Organization
Division
Category of Funding Organization Self funding
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 新久喜総合病院(埼玉県)

Other administrative information
Date of disclosure of the study information
2017 Year 08 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 No longer recruiting
Date of protocol fixation
2016 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date
2016 Year 04 Month 01 Day
Last follow-up date
2017 Year 08 Month 30 Day
Date of closure to data entry
2017 Year 09 Month 30 Day
Date trial data considered complete
2017 Year 10 Month 01 Day
Date analysis concluded
2017 Year 10 Month 30 Day

Other
Other related information

Management information
Registered date
2017 Year 07 Month 28 Day
Last modified on
2017 Year 07 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032529

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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