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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000029450
Receipt No. R000033627
Scientific Title Comparison of cytokine adsorption ability between AN69ST and PMMA hemofilter in patients with sepsis
Date of disclosure of the study information 2017/11/01
Last modified on 2018/03/14

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Basic information
Public title Comparison of cytokine adsorption ability between AN69ST and PMMA hemofilter in patients with sepsis
Acronym Comparison of cytokine adsorption ability between AN69ST and PMMA hemofilter in patients with sepsis
Scientific Title Comparison of cytokine adsorption ability between AN69ST and PMMA hemofilter in patients with sepsis
Scientific Title:Acronym Comparison of cytokine adsorption ability between AN69ST and PMMA hemofilter in patients with sepsis
Region
Japan

Condition
Condition sepsis
Classification by specialty
Emergency medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To compare the ability of sytokine adsorption between AN69ST and PMMA hemofilter in patients with sepsis
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Phase I

Assessment
Primary outcomes 1.cytokine clearance
2.HMGB1 absorption
at 2-6 hours and 12-24 hours after blood purification
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 Blood purification usign AN69ST hemofilter
Interventions/Control_2 Blood purification usign PMMA hemofilter
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 >=18 years of age
sepsis
acute kidney injury (according to RIFLE or KDIGO criteria)
able to provide informed concent
Key exclusion criteria patients considered ineligible for the study by the investigator
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroyasu Ishikura
Organization Faculty of Medicine, Fukuoka University
Division name Department of Emergency and Critical Care Medicine
Zip code
Address 7-45-1 Nanakuma, Jonan-ku, Fukuoka 814-0180, Japan
TEL 092-801-1011
Email ishikurah@fukuoka-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yasumasa Kawano
Organization Faculty of Medicine, Fukuoka University
Division name Department of Emergency and Critical Care Medicine
Zip code
Address 7-45-1 Nanakuma, Jonan-ku, Fukuoka 814-0180, Japan
TEL 092-801-1011
Homepage URL
Email kawano0301@cis.fukuoka-u.ac.jp

Sponsor
Institute Fukuoka University
Institute
Department

Funding Source
Organization none
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 福岡大学病院 救命救急センター

Other administrative information
Date of disclosure of the study information
2017 Year 11 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 Enrolling by invitation
Date of protocol fixation
2017 Year 10 Month 05 Day
Date of IRB
Anticipated trial start date
2017 Year 11 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 10 Month 06 Day
Last modified on
2018 Year 03 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033627

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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