UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032762 |
|---|---|
| Receipt number | 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 20:51:44 |
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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
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
miminekko@me.com
Sponsor or person
Institute
Sapporo Medical University School of Medicine
Department of Intensive Care Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037325
