UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029450 |
|---|---|
| Receipt number | R000033627 |
| Scientific Title | Comparison of cytokine adsorption ability between AN69ST and PMMA hemofilter in patients with sepsis |
| Date of disclosure of the study information | 2017/11/01 |
| Last modified on | 2023/10/31 18:06:17 |
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Basic information
Public title
Comparison of cytokine adsorption ability between AN69ST and PMMA hemofilter in patients with sepsis
Acronym
Comparison of cytokine adsorption ability between AN69ST and PMMA hemofilter in patients with sepsis
Scientific Title
Comparison of cytokine adsorption ability between AN69ST and PMMA hemofilter in patients with sepsis
Scientific Title:Acronym
Comparison of cytokine adsorption ability between AN69ST and PMMA hemofilter in patients with sepsis
Region
| Japan |
Condition
Condition
sepsis
Classification by specialty
| Emergency medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the ability of sytokine adsorption between AN69ST and PMMA hemofilter in patients with sepsis
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase I
Assessment
Primary outcomes
1.cytokine clearance
2.HMGB1 absorption
at 2-6 hours and 12-24 hours after blood purification
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Blood purification usign AN69ST hemofilter
Interventions/Control_2
Blood purification usign PMMA hemofilter
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
sepsis (including COVID-19)
acute kidney injury (according to RIFLE or KDIGO criteria)
able to provide informed concent
Key exclusion criteria
patients considered ineligible for the study by the investigator
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Hiroyasu |
| Middle name | |
| Last name | Ishikura |
Organization
Faculty of Medicine, Fukuoka University
Division name
Department of Emergency and Critical Care Medicine
Zip code
8140180
Address
7-45-1 Nanakuma, Jonan-ku, Fukuoka 814-0180, Japan
TEL
092-801-1011
ishikurah@fukuoka-u.ac.jp
Public contact
Name of contact person
| 1st name | Yoshihiko |
| Middle name | |
| Last name | Nakamura |
Organization
Faculty of Medicine, Fukuoka University
Division name
Department of Emergency and Critical Care Medicine
Zip code
8140180
Address
7-45-1 Nanakuma, Jonan-ku, Fukuoka 814-0180, Japan
TEL
092-801-1011
Homepage URL
pdmxy827@yahoo.co.jp
Sponsor or person
Institute
Fukuoka University
Institute
Department
Personal name
Funding Source
Organization
none
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
Fukuoka University Hospital Clinical Resarch Assist Center
Address
7-45-1 Nanakuma, Jonan-ku, Fukuoka 814-0180, Japan
Tel
0928011011
rinshou@adm.fukuoka-u.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
福岡大学病院 救命救急センター
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 11 | Month | 01 | 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
| 2017 | Year | 10 | Month | 05 | Day |
Date of IRB
| 2017 | Year | 10 | Month | 16 | Day |
Anticipated trial start date
| 2017 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2021 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 10 | Month | 06 | Day |
Last modified on
| 2023 | Year | 10 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033627
