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Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000012164
Receipt No. R000014223
Scientific Title Prospective study to investigate the performance of cytokine removal of polymethyl methacrylate hemofilters with two different membrane surface area
Date of disclosure of the study information 2013/10/30
Last modified on 2019/02/11

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Basic information
Public title Prospective study to investigate the performance of cytokine removal of polymethyl methacrylate hemofilters with two different membrane surface area
Acronym Performance of cytokine removal of polymethyl methacrylate hemofilters with two different membrane surface area
Scientific Title Prospective study to investigate the performance of cytokine removal of polymethyl methacrylate hemofilters with two different membrane surface area
Scientific Title:Acronym Performance of cytokine removal of polymethyl methacrylate hemofilters with two different membrane surface area
Region
Japan

Condition
Condition Severe sepsis, Septic shock
Classification by specialty
Infectious disease Emergency medicine Intensive care medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the effect of membrane sufface area on the performance of sytokine removal, via measurement of 17 cytokines and
HMGB-1
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Cytokine clearance of hemofilters, and duration those keep the clearance
Key secondary outcomes

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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

Not applicable
Gender Male and Female
Key inclusion criteria Svere sepsis/sptic shock patients with hypercytokinemia(IL-6 blood level is higher than 10000pg/mL) who recieve continuous hemodiafiltration using polymethylmethacrylate hemofilter
Key exclusion criteria a) Patients who need to use smaller hemofiter (mambrane surface area:0.3m2 or 0.6m2)
b) under 15 years old
c) Pregnant woman
d) Patients whom doctors judge as out of the adaptation
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shigeto Oda
Organization Chiba University, Graduate School of Medicine
Division name Department of Emergency and Critical Care Medicine
Zip code
Address 1-8-1 Inohana, Chuoh-ku, Chiba city, Chiba 260-8677, Japan.
TEL 043-226-2341
Email kyukyu@office.chiba-u.jp

Public contact
Name of contact person
1st name
Middle name
Last name Noriyuki Hattori
Organization Chiba University, Graduate School of Medicine
Division name Department of Emergency and Critical Care Medicine
Zip code
Address 1-8-1 Inohana, Chuoh-ku, Chiba city, Chiba 260-8677, Japan.
TEL 043-222-7171
Homepage URL
Email hat@shogo.com

Sponsor
Institute Department of Emergency and Critical Care Medicine, Chiba University, Graduate School of Medicine
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization Department of Emergency and Critical Care Medicine, Chiba University, Graduate School of Medicine
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

Other administrative information
Date of disclosure of the study information
2013 Year 10 Month 30 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
2013 Year 08 Month 02 Day
Date of IRB
Anticipated trial start date
2013 Year 11 Month 01 Day
Last follow-up date
2016 Year 10 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information No data are available now.

Management information
Registered date
2013 Year 10 Month 30 Day
Last modified on
2019 Year 02 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014223


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