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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000017263
Receipt No. 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

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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
Email 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
Email hiro-kamoi@med.osaka-cu.ac.jp

Sponsor
Institute Graduate School of Medicine, Osaka City University
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019882

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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