UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038302 |
|---|---|
| Receipt number | R000043641 |
| Scientific Title | An observational study of the background, treatment status, and prognosis of patients with severe septic shock |
| Date of disclosure of the study information | 2019/11/01 |
| Last modified on | 2024/03/12 15:01:25 |
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Basic information
Public title
An observational study of the background, treatment status, and prognosis of patients with severe septic shock
Acronym
Best Available Treatment for septic shock registry
Scientific Title
An observational study of the background, treatment status, and prognosis of patients with severe septic shock
Scientific Title:Acronym
Best Available Treatment for septic shock registry
Region
| Japan |
Condition
Condition
Severe septic shock
Classification by specialty
| Emergency medicine | Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effective treatment of patients with septic shock by clarifying various treatment conditions and evaluating patient background and prognosis in Japan
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
28-day mortality
Key secondary outcomes
ICU mortality
90-day mortality
Duration of mechanical ventilation
Length of stay in the ICU
90-day reintegration
90-day degree of care(Barthel Index)
90-day short-term memory score(Short Memory Questionnaire)
PTSD associated with ICU treatment(Impact of Event Scale-reviced)
etc.
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 18 years of age or older admitted to the intensive care unit after July 2019
2) Septic shock patients: need a vasopressor to maintain blood pressure >=65 mmHg after infusion, and sustained high lactate >2 mmol/L
3) Noradrenaline (dose >=0.2 gamma) administered within 24 hours after diagnosis of sepsis
Key exclusion criteria
1) Cases of ICU discharge and death within 48 hours of enrollment
2) Patients with a limited long-term prognosis due to coexisting malignancy
3) Cases in which new organ damage had already preceded the onset of sepsis
4) Acute myocardial infarction, heart disease (New York Heart Association[NYHA]4)
5) Severe chronic liver disease (Child-Pugh C)
6) Attending physician's decision
7) Opt-out applicant by patient or proxy consenter
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | Yu |
| Middle name | |
| Last name | Kawazoe |
Organization
Tohoku University Graduate School of Medicine
Division name
Division of Emergency and Critical Care Medicine
Zip code
980-8574
Address
1-1 Seiryo-machi, Aoba-ku, Sendai, 980-8574, Japan
TEL
022-717-7489
yu.kawazoe.b7@tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Yu |
| Middle name | |
| Last name | Kawazoe |
Organization
Tohoku University Graduate School of Medicine
Division name
Division of Emergency and Critical Care Medicine
Zip code
980-8574
Address
1-1 Seiryo-machi, Aoba-ku, Sendai, 980-8574, Japan
TEL
022-717-7489
Homepage URL
yu.kawazoe.b7@tohoku.ac.jp
Sponsor or person
Institute
Tohoku University Graduate School of Medicine Division of Emergency and Critical Care Medicine
Institute
Department
Personal name
Funding Source
Organization
Tohoku University Graduate School of Medicine Division of Emergency and Critical Care Medicine
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Hokkaido University Hospital Department of Emergency Medicine, Iwate Medical University, Fukushima Medical University Hospital, Gunma University Hospital, Tokyo Women's Medical University Adachi Medical Center, Saiseikai Utsunomiya Hospital, Saiseikai Yokohamashi Tobu Hospital, Kitasato University Hospital, Nagoya Medical Center, Osaka Prefectural Nakakawachi Emergency and Critical Care Center, Nara Prefecture General Medical Center, Wakayama Medical University, Okayama University, Hiroshima University, Kagawa University, Ehime University Hospital, Fukuoka University, University of Occupational and Environmental Health, Saga University, National Hospital Organization Kumamoto Medical Center, Kagoshima University, Shimane University, Shin-yurigaoka General Hospital, Sendai City Hospital, Sendai Medical Center
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee Tohoku University Graduate School of Medicine
Address
2-1 Seiryo-machi, Aoba-ku, Sendai, 980-8575, Japan
Tel
022-717-8007
med-kenkyo@grp.tohoku.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 | 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
Open public recruiting
Date of protocol fixation
| 2019 | Year | 07 | Month | 18 | Day |
Date of IRB
| 2019 | Year | 09 | Month | 17 | Day |
Anticipated trial start date
| 2020 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 04 | Month | 28 | Day |
Date of closure to data entry
| 2023 | Year | 04 | Month | 28 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Collect clinical data of severe sepic shock
Prospective and retrospective cohort study
Management information
Registered date
| 2019 | Year | 10 | Month | 15 | Day |
Last modified on
| 2024 | Year | 03 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043641
| Research Plan | |
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| 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 |
