UMIN-CTR Clinical Trial

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

steroid resistant drug-induced lung injury

Classification by specialty

Pneumology

Classification by malignancy

Others

Genomic information

NO

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

Primary outcomes

P / F ratio at 48 hours after PMX treatment.

Key secondary outcomes

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Graduate School of Medicine, Osaka City University

Institute

Department

Personal name

Organization

Osaka City University

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2015

Year

04

Month

27

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related 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