UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Efficacy of Polimyxin B immobilized fiber column direct hemoperfusion:A prospective study
Title of the study (Brief title)	Mie PMX study
Region	Japan

Condition
Condition	septic shock,ARDS,interstitial pneumonia
Classification by specialty	Pneumology Nephrology Surgery in general Emergency medicine Intensive care medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To examine the absorbed materials of PMX therapy
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	To examine the absorbed materials of PMX therapy
Key secondary outcomes	Survival rate at 28 days after ICU admission

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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1: endotoxemia or Gram-negative bacillus infection suspected 2: A-D at the same time two or more items A: body temperature is more than 38 degrees or less than 36 degrees B: heart rate is more than 90/min C: respiratory rate is more than 20/min,less than PaCO2 32 mmHg D: white blood cell count is more than 12000/mm3, or less than 4000/mm3 3: septic shock
Key exclusion criteria	A: patients with underlying disease that is considered to ensure death within a week B: malignant disease C: high risk of bleeding cases D: combination with other investigational drugs E: judged unsuitable for this survey F: not obtained consent from the person or agent G: minors
Target sample size	20

Research contact person
Name of lead principal investigator	Mika Fujimoto
Organization	Mie University Graduate School of Medicine
Division name	Department of Cardiology and Nephrology
Address	Tsu, Mie Prefecture Edobashi 2-174
TEL	059-231-5015
Email	mikagoto125416@yhoo.co.jp

Public contact
Name of contact person	Mika Fujimoto
Organization	Mie University Graduate School of Medicine
Division name	Department of Cardiology and Nephrology
Address	Tsu, Mie Prefecture Edobashi 2-174
TEL	059-231-5015
Homepage URL
Email	mikagoto125416@yahoo.co.jp

Sponsor
Institute	Department of Cardiology and Nephrology,Mie 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	Toray Medical Co., Ltd.
Organization
Division
Category of Funding Organization	Profit organization
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	三重大学医学部附属病院

Other administrative information
Date of disclosure of the study information	2016 Year 05 Month 01 Day

Progress
Recruitment status	Main results already published
Date of protocol fixation	2016 Year 04 Month 01 Day
Anticipated trial start date	2016 Year 05 Month 01 Day
Last follow-up date
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	prospective study

Management information
Registered date	2016 Year 04 Month 27 Day
Last modified on	2016 Year 04 Month 27 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025468