UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022088 |
|---|---|
| Receipt number | R000025468 |
| Scientific Title | Efficacy of Polimyxin B immobilized fiber column direct hemoperfusion:A prospective study |
| Date of disclosure of the study information | 2016/05/01 |
| Last modified on | 2016/04/27 00:05:48 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Efficacy of Polimyxin B immobilized fiber column direct hemoperfusion:A prospective study
Acronym
Mie PMX study
Scientific Title
Efficacy of Polimyxin B immobilized fiber column direct hemoperfusion:A prospective study
Scientific Title:Acronym
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
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
| 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
| 1st name | |
| Middle name | |
| Last name | Mika Fujimoto |
Organization
Mie University Graduate School of Medicine
Division name
Department of Cardiology and Nephrology
Zip code
Address
Tsu, Mie Prefecture Edobashi 2-174
TEL
059-231-5015
mikagoto125416@yhoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Mika Fujimoto |
Organization
Mie University Graduate School of Medicine
Division name
Department of Cardiology and Nephrology
Zip code
Address
Tsu, Mie Prefecture Edobashi 2-174
TEL
059-231-5015
Homepage URL
mikagoto125416@yahoo.co.jp
Sponsor or person
Institute
Department of Cardiology and Nephrology,Mie University Graduate School of Medicine
Institute
Department
Personal name
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)
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
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 |
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
Main results already published
Date of protocol fixation
| 2016 | Year | 04 | Month | 01 | Day |
Date of IRB
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
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025468
