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
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
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
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
