UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051464 |
|---|---|
| Receipt number | R000058678 |
| Scientific Title | PolyMyXin-B direct hemoperfusion OPTimal Initiation timing with Catecholamine study (PMX-OPTIC study) |
| Date of disclosure of the study information | 2023/06/27 |
| Last modified on | 2023/10/10 17:11:27 |
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Basic information
Public title
PolyMyXin-B direct hemoperfusion OPTimal Initiation timing with Catecholamine study (PMX-OPTIC study)
Acronym
PMX-OPTIC study
Scientific Title
PolyMyXin-B direct hemoperfusion OPTimal Initiation timing with Catecholamine study (PMX-OPTIC study)
Scientific Title:Acronym
PMX-OPTIC study
Region
| Japan |
Condition
Condition
Septic shock
Classification by specialty
| Emergency medicine | Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to investigate and analyze the maximum vasopressor dose administered before and after the initiation of Polymyxin B immobilized fiber column direct hemoperfusion (PMX-DHP, PMX), and examine its relationship with patient outcomes.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
28-day mortality rate
Key secondary outcomes
7-day survival rate
Length of hospital stay
Length of ICU stay
Duration of mechanical ventilation
CRP/Albumin/Lymphocyte count on the 14th day after ICU admission (closest to the 14th day based on blood samples collected between the 11th and 17th day)
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
1. Patients aged 18 years and older admitted to the ICU.
2. Patients treated with PMX for septic shock (diagnosed based on Sepsis-3 criteria).
3. Patients using vasopressor at the time of PMX initiation.
4. Patients who underwent their first PMX during the same hospitalization.
Key exclusion criteria
1. Cases of End of Life/Terminal Care where treatment was not the primary objective.
2. Patients who received interventions for circulatory support such as ECMO, VAD, IMPELLA (excluding IABP).
Target sample size
600
Research contact person
Name of lead principal investigator
| 1st name | Yuji |
| Middle name | |
| Last name | Takahashi |
Organization
Hitachi General Hospital
Division name
Department of Emergecy and Critical Care Medicine
Zip code
317-0077
Address
2-1-1, Jonancyo Hitachi, Ibaraki 317-0077, JAPAN
TEL
0294-23-1111
yuji.mail@me.com
Public contact
Name of contact person
| 1st name | Kensuke |
| Middle name | |
| Last name | Nakamura |
Organization
Teikyo University
Division name
Department of Emergency Medicine
Zip code
178-8605
Address
2-11-1 Kaga, Itabashi-Ku, Tokyo 117-003, JAPAN
TEL
03-3964-1211
Homepage URL
mamashockpapashock@yahoo.co.jp
Sponsor or person
Institute
Teikyo University
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Teikyo University Ethical Review Board for Medical and Health Research Involving Human Subjects
Address
2-11-1 Kaga, Itabashi-Ku, Tokyo 117-003, JAPAN
Tel
03-3964-1211
turb-office@teikyo-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
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 06 | Month | 27 | 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
No longer recruiting
Date of protocol fixation
| 2022 | Year | 05 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 06 | Month | 13 | Day |
Anticipated trial start date
| 2022 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Data collection in progress
Management information
Registered date
| 2023 | Year | 06 | Month | 27 | Day |
Last modified on
| 2023 | Year | 10 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058678
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
