UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000012748
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Institute Chiba-Hokusoh Hospital, Nippon Medical School
Institute
Department

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
URL(English) https://upload.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


Contact us.