UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037613 |
|---|---|
| Receipt number | R000042873 |
| Scientific Title | The comparison of circulatory effect of CRRT between AN69ST and polysulphone membrane in patients with septic shock: a retrospective observational study |
| Date of disclosure of the study information | 2019/08/06 |
| Last modified on | 2020/04/04 14:42:22 |
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Basic information
Public title
The comparison of circulatory effect of CRRT between AN69ST and polysulphone membrane in patients with septic shock: a retrospective observational study
Acronym
AN69ST membrane for septic shock
Scientific Title
The comparison of circulatory effect of CRRT between AN69ST and polysulphone membrane in patients with septic shock: a retrospective observational study
Scientific Title:Acronym
AN69ST membrane for septic shock
Region
| Japan |
Condition
Condition
Septic shock
Classification by specialty
| Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The acrylonitrile-co-methallyl sulfonate surface-treated (AN69ST) membrane is expected to improve hemodynamics in patients with sepsis by cytokine adsorption. However, the clinical literature on AN69ST membranes is scarce. The aim of this study is to reveal whether AN69ST membrane improves the circulation of patients with septic shock.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
the vasopressor dependency index during the 12 hours after the start of CRRT.
Key secondary outcomes
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
18 years of age or older who required CRRT for septic shock.
Key exclusion criteria
patients who died within 24 hours after starting CRRT, were treated by direct hemoperfusion therapy with polymyxin B immobilized fiber cartridges (PMX-DHP), were treated by extracorporeal membrane oxygenation (ECMO) and were dialyzed by other membranes than PS and AN69ST for CRRT.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Mami |
| Middle name | |
| Last name | Shibata |
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
mami517@wakayama-med.ac.jp
Public contact
Name of contact person
| 1st name | Mami |
| Middle name | |
| Last name | Shibata |
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
mami517@wakayama-med.ac.jp
Sponsor or person
Institute
Wakayama Medical University
Institute
Department
Personal name
Funding Source
Organization
Wakayama Medical University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
IRB of WMU
Address
Wakayama
Tel
0734410603
eccm@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
| 2019 | Year | 08 | Month | 06 | Day |
Related information
URL releasing protocol
https://onlinelibrary.wiley.com/doi/abs/10.1111/1744-9987.13462
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
40
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
| 2019 | Year | 08 | Month | 02 | Day |
Date of IRB
| 2019 | Year | 08 | Month | 02 | Day |
Anticipated trial start date
| 2019 | Year | 08 | Month | 02 | Day |
Last follow-up date
| 2019 | Year | 08 | Month | 02 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
retorospective observational study
Management information
Registered date
| 2019 | Year | 08 | Month | 06 | Day |
Last modified on
| 2020 | Year | 04 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042873
