UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000016654
Receipt number R000019332
Scientific Title Time course of serum interleukin-6 concentration during longer duration polymyxin B-immobilized fiber column hemoperfusion
Date of disclosure of the study information 2015/03/01
Last modified on 2019/05/15 12:00:44

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Basic information

Public title

Time course of serum interleukin-6 concentration during longer duration polymyxin B-immobilized fiber column hemoperfusion

Acronym

Time course of serum IL-6 concentration during longer duration PMX-DHP

Scientific Title

Time course of serum interleukin-6 concentration during longer duration polymyxin B-immobilized fiber column hemoperfusion

Scientific Title:Acronym

Time course of serum IL-6 concentration during longer duration PMX-DHP

Region

Japan


Condition

Condition

septic shock

Classification by specialty

Infectious disease Intensive care medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To investigate the time course of serum IL-6 concentration during longer duration PMX-DHP

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Explanatory

Developmental phase

Phase II


Assessment

Primary outcomes

Time course of serum IL-6 concentration during longer duration PMX-DHP

Key secondary outcomes

Time course of hemodynamic variables during longer duration PMX-DHP
Time course of blood gas analysis results during longer duration PMX-DHP
Time course of ventilation and oxygenation variables (FiO2, PaO2/FiO2) during longer duration PMX-DHP
Renal function (BUN, Cre, eGFR), urinary output and need for renal replacement therapy
Length of ICU stay, and length of hospital stay
28 day mortality
Duration of mechanical ventilation
Acute physiology and chronic health evaluation II (APACHE II) score, sequential organ failure assessment (SOFA) score, and disseminated intravascular coagulation (DIC) score by the Japanese Association for Acute Medicine (JAAM)
Laboratory marker of inflammation (white blood cell, c-reactive protein, presepsin and procalcitonin)
Duration of antimicrobial therapy


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Dose comparison

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

Longer duration of polymyxin B-immobilized fiber column hemoperfusion (12 to 24 hours or occurrence of circuit coagulation)

Interventions/Control_2

Conventional durationof polymyxin B-immobilized fiber column hemoperfusion (2 hours or occurrence of circuit coagulation)

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

Adult ICU patients with sepsis who need high dose catecholamine (catecholamine index equal to or higher than 10)

Key exclusion criteria

Patients who have allergy for polymyxin B
Pregnant or lactating women
Patients who want to withdraw or withheld the treatment
Attending physicians' decision

Target sample size

30


Research contact person

Name of lead principal investigator

1st name Kyohei
Middle name
Last name Miyamoto

Organization

Wakayama Medical University

Division name

Department of Emergency and Critical Care Medicine

Zip code

6418509

Address

811-1 Kimiidera, Wakayama-City, Wakayama, 641-8509, JAPAN

TEL

0734410603

Email

go.go.kyohei.miyamoto@gmail.com


Public contact

Name of contact person

1st name Kyohei
Middle name
Last name Miyamoto

Organization

Wakayama Medical University

Division name

Department of Emergency and Critical Care Medicine

Zip code

6418509

Address

811-1 Kimiidera, Wakayama-City, Wakayama, 641-8509, JAPAN

TEL

0734410603

Homepage URL


Email

go.go.kyohei.miyamoto@gmail.com


Sponsor or person

Institute

Department of Emergency and Critical Care Medicine, Wakayama Medical University

Institute

Department

Personal name



Funding Source

Organization

Toray Industries

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

IRB of WMU

Address

811-1 Kimiidera, Wakayama-City, Wakayama, 641-8509, JAPAN

Tel

073-447-2300

Email

gomadofu@wakayama-med.ac.jp


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 03 Month 01 Day


Related information

URL releasing protocol

https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr.cgi?function=brows&action=brows&type=summary&language

Publication of results

Published


Result

URL related to results and publications

https://rrtjournal.biomedcentral.com/articles/10.1186/s41100-019-0217-8

Number of participants that the trial has enrolled

23

Results

See abovementioned URL.

Results date posted

2019 Year 05 Month 14 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

See abovementioned URL.

Participant flow

See abovementioned URL.

Adverse events

See abovementioned URL.

Outcome measures

See abovementioned URL.

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2015 Year 02 Month 17 Day

Date of IRB

2015 Year 03 Month 01 Day

Anticipated trial start date

2015 Year 03 Month 10 Day

Last follow-up date

2016 Year 12 Month 31 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 02 Month 27 Day

Last modified on

2019 Year 05 Month 15 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019332


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name