UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Analysis of the influence of polymyxin B-immobilized fiber column direct hemoperfusion (PMX) therapy on blood lipid mediators in sepsis patients
Title of the study (Brief title)	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	Yoshiki Masuda
Organization	Sapporo Medical University School of Medicine
Division name	Department of Intensive Care Medicine
Address	South1 West16, Chuo-ku, Sapporo
TEL	011-611-2111
Email	miminekko@me.com

Public contact
Name of contact person	Yoshiki Masuda
Organization	Sapporo Medical University School of Medicine
Division name	Department of Intensive Care Medicine
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)

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

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2018 Year 05 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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