UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017263 |
|---|---|
| Receipt number | R000019882 |
| Scientific Title | Investigation of the effect of direct hemoperfusion with polymyxin B-immobilized fiber on steroid resistant drug-induced lung injury. |
| Date of disclosure of the study information | 2015/04/27 |
| Last modified on | 2017/10/26 08:20:42 |
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Basic information
Public title
Investigation of the effect of direct hemoperfusion with polymyxin B-immobilized fiber on steroid resistant drug-induced lung injury.
Acronym
Investigation of the effect of direct hemoperfusion with polymyxin B-immobilized fiber on steroid resistant drug-induced lung injury.
Scientific Title
Investigation of the effect of direct hemoperfusion with polymyxin B-immobilized fiber on steroid resistant drug-induced lung injury.
Scientific Title:Acronym
Investigation of the effect of direct hemoperfusion with polymyxin B-immobilized fiber on steroid resistant drug-induced lung injury.
Region
| Japan |
Condition
Condition
steroid resistant drug-induced lung injury
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Investigation of the effect of direct hemoperfusion with polymyxin B-immobilized fiber(PMX)
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
P / F ratio at 48 hours after PMX treatment.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
polymyxin B-immobilized fiber column
I do for 2 days. A principle is performed for more than 6 hours per once.
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)PaO2 is less than 80 Torr by the patient diagnosed as steroid treatment-resistant drug-induced lung injury..
mild PaO2 >= 80 Torr.
moderate 60 Torr<= PaO2<= 80 Torr
severe PaO2 < 60 Torr( PaO2/FiO2 < 300).
2) Patients who received PMX-DPH evaluated with P/F ratio.( P/F ratio is less than 300 or less than 60 mmHg of PaO2 under room air inspiration)
Key exclusion criteria
1) pregnant woman, lactating woman or patient with a possibility of the pregnancy
2) The patients who has the past of allergy to blood purification and extracorporeal circulation method of treatment
3) Other non-approval medical equipment or the patient who participates in a clinical trial of medicine approving ly.
4) The patients for whom the value of this clinical study is difficult for a terminal cancer's, chronic renal insufficiency's and death's within 7 days being predicted
5) The patients who could admit clear pulmonary infection, pneumothorax, pulmonary embolism and heart failure by a clinical judgement
6) The patients who has an experience of PMX-DPH before agreement acquisition
7) The patients who judged that an implementation responsibility doctor or an allotment doctor was unsuitable
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroshi Kamoi |
Organization
Graduate School of Medicine, Osaka City University
Division name
department of sports medicine
Zip code
Address
1-4-3, Asahimachi, Abeno-ku, Osaka-shi, Osaka
TEL
06-6645-2121
hiro-kamoi@med.osaka-cu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroshi Kamoi |
Organization
Graduate School of Medicine, Osaka City University
Division name
department of respiratory medcine
Zip code
Address
1-4-3, Asahimachi, Abeno-ku, Osaka-shi, Osaka
TEL
06-6645-2121
Homepage URL
hiro-kamoi@med.osaka-cu.ac.jp
Sponsor or person
Institute
Graduate School of Medicine, Osaka City University
Institute
Department
Personal name
Funding Source
Organization
Osaka City University
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
| 2015 | Year | 04 | Month | 27 | 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
Terminated
Date of protocol fixation
| 2015 | Year | 03 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 04 | Month | 27 | Day |
Last follow-up date
| 2018 | Year | 04 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 04 | Month | 24 | Day |
Last modified on
| 2017 | Year | 10 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019882
