UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effectiveness of PolyMyXin B immobilized fiber HemoPerfusion in patients with septic shock due to Gram-Negative Bacillus Infection
Title of the study (Brief title)	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	Nobuyuki Saito
Organization	Chiba-Hokusoh Hospital, Nippon Medical School
Division name	Shock and Trauma Center
Address	1715, Kamagari, Inzai, Chiba pref. 270-1694 JAPAN
TEL	0476-99-1111
Email	nobu99@nms.ac.jp

Public contact
Name of contact person	Nobuyuki Saito
Organization	Chiba-Hokusoh Hospital, Nippon Medical School
Division name	Shock and Trauma Center
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 09 Month 26 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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