UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Prospective study to investigate the performance of cytokine removal of polymethyl methacrylate hemofilters with two different membrane surface area
Title of the study (Brief title)	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

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	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	Shigeto Oda
Organization	Chiba University, Graduate School of Medicine
Division name	Department of Emergency and Critical Care Medicine
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	Noriyuki Hattori
Organization	Chiba University, Graduate School of Medicine
Division name	Department of Emergency and Critical Care Medicine
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

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)

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

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2013 Year 08 Month 02 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000014223