UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Investigation of the effect of direct hemoperfusion with polymyxin B-immobilized fiber on steroid resistant drug-induced lung injury.
Title of the study (Brief title)	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	Hiroshi Kamoi
Organization	Graduate School of Medicine, Osaka City University
Division name	department of sports medicine
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	Hiroshi Kamoi
Organization	Graduate School of Medicine, Osaka City University
Division name	department of respiratory medcine
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)

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

Progress
Recruitment status	Terminated
Date of protocol fixation	2015 Year 03 Month 31 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000019882