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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000013816
Receipt No. R000016116
Scientific Title Intradialytic hypotension prevention by intermittent infusion HDF
Date of disclosure of the study information 2014/04/30
Last modified on 2016/05/01

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Basic information
Public title Intradialytic hypotension prevention by intermittent infusion HDF
Acronym III study
Scientific Title Intradialytic hypotension prevention by intermittent infusion HDF
Scientific Title:Acronym III study
Region
Japan

Condition
Condition Chronic Kidney Failure
Classification by specialty
Nephrology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We accumulate I-HDF cases with various IDH (intradyalytic hypotension) and inspect usefulness of the I-HDF therapy by comparing patient's clinical background.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The change of blood pressure during hemodialysis (including frequency of measures for hypotension)
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria # On hemodialysis thrice weekly.
# Frequent intradialytic hypotension episodes (systolic blood pressure drop greater than 20mmHg during HD, or intradialytic hypotensive episode that needs any treatment)
Key exclusion criteria # Cardiovascular or cerebrovascular event in the last 3 month.
# Obvious inflammatory diseases.
# Obvious and active infective diseases
# Systolic blood pressure rise over 150mmHg during HD.
# On dialyser with membrane area of greater than 2.2 square-meter, or less than 0.8 square-meter.
# On combination therapy with adsorptive device (e.g. Lixcel)
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yutaka Koda
Organization Koda Medical and Dialysis Clinic
Division name Department of Internal Medicine
Zip code
Address 3748 Yoshida, Tsubame city, Niigata, JAPAN
TEL 0256-92-0001
Email ykodan@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Yutaka Koda
Organization Koda Medical and Dialysis Clinic
Division name Department of Internal Medicine
Zip code
Address 3748 Yoshida, Tsubame city, Niigata, JAPAN
TEL 0256-92-0001
Homepage URL
Email ykodan@gmail.com

Sponsor
Institute Koda Medical and Dialysis Clinic
Institute
Department

Funding Source
Organization Toray Industries, Inc.
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 甲田内科クリニック(新潟県)
中川内科クリニック(栃木県)
岩淵クリニック(栃木県)
行田総合病院(埼玉県)
久喜総合病院(埼玉県)
小川病院(埼玉県)
柏崎総合医療センター(新潟県)
新潟臨港病院(新潟県)

Other administrative information
Date of disclosure of the study information
2014 Year 04 Month 30 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications http://link.springer.com/article/10.1007/s10157-016-1270-z
Number of participants that the trial has enrolled
Results Sixty eight patients completed the study. Nine were dropouts. During I-HDF, interventions for symptomatic hypotension were reduced significantly from 4.5 to 3.0 (per person-month, median) and intradialytic systolic blood pressure was 4 mmHg higher on average. The heart rate was lower during I-HDF than HD in the later session. I-HDF could reduce interventions for IDH. It is accompanied with the increased intradialytic blood pressure and the less tachycardia, suggesting less sympathetic stimulation occurs. Thus, I-HDF could be beneficial for some hypotension-prone patients.
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
2014 Year 04 Month 22 Day
Date of IRB
Anticipated trial start date
2014 Year 05 Month 01 Day
Last follow-up date
2014 Year 12 Month 31 Day
Date of closure to data entry
2015 Year 01 Month 31 Day
Date trial data considered complete
2015 Year 03 Month 31 Day
Date analysis concluded
2015 Year 10 Month 01 Day

Other
Other related information Frequency and severity of intradialytic hypotension(IDH),
Therapeutic effect of I-HDF for IDH,
Analysis of background-factors of the I-HDF treated patients with respect to effectiveness.

Management information
Registered date
2014 Year 04 Month 25 Day
Last modified on
2016 Year 05 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016116

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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