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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000038302
Receipt No. 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 2019/10/15

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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) Adult patients (>=18 years of age) admitted to ICU
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) Patients without data of blood gas analysis and urine volume every 6 hours up to 48 hours in ICU
2) Malignant tumor cases with limited long-term prognosis
3) Acute myocardial infarction, heart disease(New York Heart Association[NYHA]4)
4) Severe chronic liver disease(Child-Pugh C)
5) Attending physician's decision
6) 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
Email 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
Email yu.kawazoe.b7@tohoku.ac.jp

Sponsor
Institute Tohoku University Graduate School of Medicine Division of Emergency and Critical Care Medicine
Institute
Department

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
Name of secondary funder(s)

IRB Contact (For public release)
Organization Tohoku University Graduate School of Medicine Division of Emergency and Critical Care Medicine
Address 1-1 Seiryo-machi, Aoba-ku, Sendai, 980-8574, Japan
Tel 022-717-7489
Email yu.kawazoe.b7@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 Preinitiation
Date of protocol fixation
2019 Year 07 Month 18 Day
Date of IRB
Anticipated trial start date
2020 Year 01 Month 01 Day
Last follow-up date
2024 Year 03 Month 31 Day
Date of closure to data entry
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
2019 Year 10 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043641

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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