UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000012748
Receipt number R000014896
Scientific Title Effectiveness of PolyMyXin B immobilized fiber HemoPerfusion in patients with septic shock due to Gram-Negative Bacillus Infection
Date of disclosure of the study information 2014/01/10
Last modified on 2016/08/02 13:08:06

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Basic information

Public title

Effectiveness of PolyMyXin B immobilized fiber HemoPerfusion in patients with septic shock due to Gram-Negative Bacillus Infection

Acronym

PMX-HP study

Scientific Title

Effectiveness of PolyMyXin B immobilized fiber HemoPerfusion in patients with septic shock due to Gram-Negative Bacillus Infection

Scientific Title:Acronym

PMX-HP study

Region

Japan


Condition

Condition

Septic shock due to Gram-Negative Bacillus Infection

Classification by specialty

Medicine in general Nephrology Surgery in general
Emergency medicine Intensive care medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To clearfy the effectiveness of PMX-HP therapy

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Others

Developmental phase

Not applicable


Assessment

Primary outcomes

Survival rate at 28 days after ICU admission

Key secondary outcomes

Survival rate at hospital discharge


Base

Study type

Observational


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


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

18 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Patients who fell to septic shock, has been detected gram-negative bacilli from the culture specimen as causative.And patients with administration of broad spectorum antimicrobial agent immediately after diagnosis of sepsis.

Key exclusion criteria

none

Target sample size

350


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Nobuyuki Saito

Organization

Chiba-Hokusoh Hospital, Nippon Medical School

Division name

Shock and Trauma Center

Zip code


Address

1715, Kamagari, Inzai, Chiba pref. 270-1694 JAPAN

TEL

0476-99-1111

Email

nobu99@nms.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Nobuyuki Saito

Organization

Chiba-Hokusoh Hospital, Nippon Medical School

Division name

Shock and Trauma Center

Zip code


Address

1715, Kamagari, Inzai, Chiba pref. 270-1694 JAPAN

TEL

0476-99-1111

Homepage URL


Email

nobu99@nms.ac.jp


Sponsor or person

Institute

Chiba-Hokusoh Hospital, Nippon Medical School

Institute

Department

Personal name



Funding Source

Organization

University of Tsukuba faculty of medicine, Department of clinical trial and clinical epidemiology

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor

Tsukuba critical path research and education integrated leading center

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

2014 Year 01 Month 10 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

Completed

Date of protocol fixation

2013 Year 09 Month 26 Day

Date of IRB


Anticipated trial start date

2013 Year 12 Month 01 Day

Last follow-up date

2014 Year 12 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

The study is to perform a proportional hazards analysis on the basis of a retrospective case registration for patients with septic shock caused by gram-negative bacillus infection.


Management information

Registered date

2014 Year 01 Month 03 Day

Last modified on

2016 Year 08 Month 02 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014896


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name