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
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
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
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
