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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000032762
Receipt No. R000037325
Scientific Title Analysis of the influence of polymyxin B-immobilized fiber column direct hemoperfusion (PMX) therapy on blood lipid mediators in sepsis patients
Date of disclosure of the study information 2018/06/01
Last modified on 2018/05/29

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Basic information
Public title Analysis of the influence of polymyxin B-immobilized fiber column direct hemoperfusion (PMX) therapy on blood lipid mediators in sepsis patients
Acronym Analysis of the influence of polymyxin B-immobilized fiber column direct hemoperfusion (PMX) therapy on blood lipid mediators in sepsis patients
Scientific Title Analysis of the influence of polymyxin B-immobilized fiber column direct hemoperfusion (PMX) therapy on blood lipid mediators in sepsis patients
Scientific Title:Acronym Analysis of the influence of polymyxin B-immobilized fiber column direct hemoperfusion (PMX) therapy on blood lipid mediators in sepsis patients
Region
Japan

Condition
Condition sepsis
Classification by specialty
Intensive care medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To reveal the mechanism of the effect of PMX treatment by measuring the blood lipid mediators of PMX-treated patients over time and comprehensively and analyzing the correlation of lipid mediator level with the improvement of the patient's condition such as elevation in blood pressure.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The relationship between lipid mediators concentration and the effect of blood pressure increase
Key secondary outcomes age, sex, source disease, APACHE II score, SOFA score, combination therapy(blood purification therapy, steroid therapy, immunoglobulin therapy, etc.), Infection site, infectious species, vital signs

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
18 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria The patients who received PMX treatment for septic shock and agreed with this study by the written document.
Key exclusion criteria Patients who are under 18 years old, pregnant, didn't agree with this study, have the contraindication for anticoagulant use, and are judged inappropriate by the researchers.
Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshiki Masuda
Organization Sapporo Medical University School of Medicine
Division name Department of Intensive Care Medicine
Zip code
Address South1 West16, Chuo-ku, Sapporo
TEL 011-611-2111
Email miminekko@me.com

Public contact
Name of contact person
1st name
Middle name
Last name Yoshiki Masuda
Organization Sapporo Medical University School of Medicine
Division name Department of Intensive Care Medicine
Zip code
Address South1 West16, Chuo-ku, Sapporo
TEL 011-611-2111
Homepage URL
Email miminekko@me.com

Sponsor
Institute Sapporo Medical University School of Medicine
Department of Intensive Care Medicine
Institute
Department

Funding Source
Organization Sapporo Medical University 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
2018 Year 06 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 Preinitiation
Date of protocol fixation
2018 Year 05 Month 01 Day
Date of IRB
Anticipated trial start date
2018 Year 06 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 We will analyze relevant factors by collecting data in the future.

Management information
Registered date
2018 Year 05 Month 29 Day
Last modified on
2018 Year 05 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037325

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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