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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000036349
Receipt No. R000041412
Scientific Title A multicenter, prospective observational study of new criteria for sepsis (Sepsis-3)
Date of disclosure of the study information 2019/06/01
Last modified on 2019/03/29

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Basic information
Public title A multicenter, prospective observational study of new criteria for sepsis (Sepsis-3)
Acronym Observational study for Sepsis-3
MAESTRO study
Scientific Title A multicenter, prospective observational study of new criteria for sepsis (Sepsis-3)
Scientific Title:Acronym Observational study for Sepsis-3
MAESTRO study
Region
Japan

Condition
Condition Sepsis (sepsis-3 criteria)
Classification by specialty
Emergency medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the clinical characteristics, treatments, and prognosis of patients with sepsis based on Sepsis-3 criteria in Japan.
Basic objectives2 Others
Basic objectives -Others We aimed to evaluate the compliance of one-hour bundle, proposed in 2018, for patients with sepsis based on sepsis-3 criteria. Besides, we aimed to evaluated the impact of the compliance of one-hour bundle to the patient outcomes.
Trial characteristics_1 Confirmatory
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes In-hospital mortality
Key secondary outcomes Illness severity indicated by SOFA and APACHE II score at the time of registration.

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
16 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients are eligible for this study if they meet the following criteria.
1) They are older than 16 years.
2) They fulfill the Sepsis-3 criteria, i.e., have a proven or suspected infection and an acute increase of 2 or more points in SOFA score.
3) They are admitted to the intensive care unit (ICU).
If the infection is combined with other diseases during ICU treatment, and the Sepsis-3 criteria are met, only the first infectious complication is targeted.
Key exclusion criteria 1) Patients with cardiopulmonary arrest on hospital arrival
2) Patients who do not want sustained end-of-life care
3) Patients deemed ineligible as study participants by the research director
4) Patients transferred from other hospitals
Target sample size 600

Research contact person
Name of lead principal investigator
1st name Hiroshi
Middle name
Last name Ogura
Organization Osaka University Graduate School of Medicine
Division name Department of Traumatology and Acute Critical Medicine
Zip code 565-0871
Address 2-15 Yamadaoka, Suita, Osaka
TEL +81-6-6879-5707
Email ogura@hp-emerg.med.osaka-u.ac.jp

Public contact
Name of contact person
1st name Shuta
Middle name
Last name Fukuda
Organization Japanese Association for Acute Medicine
Division name Special committee on multi institutional joint research
Zip code 113-0033
Address 3-3-12, Hongo, Bunkyo-ku, Tokyo
TEL +81-3-5840-9870
Homepage URL http://www.jaam.jp/html/jaamforecast/index.html
Email editorial-jaam@umin.net

Sponsor
Institute Japanese Association for Acute Medicine
Institute
Department

Funding Source
Organization Japanese Association for Acute Medicine, Japan Society for the Promotion of the Science
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Osaka University Hospital Ethics Review Committee for observational studies
Address 2-2 Yamadaoka, Suita, Osaka
Tel +81-6-6210-8289
Email rinri@hp-crc.med,osaka-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
2019 Year 06 Month 01 Day

Related information
URL releasing protocol http://www.jaam.jp/html/jaammaestro/index.html
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 03 Month 01 Day
Date of IRB
Anticipated trial start date
2019 Year 06 Month 01 Day
Last follow-up date
2019 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information We aim to evaluate the clinical characteristics, treatments, and prognosis of patients with sepsis based on Sepsis-3 criteria in Japan. We also aim to evaluate both compliance with the one-hour bundle proposed in 2018 for patients with sepsis based on the Sepsis-3 criteria and the impact of compliance with the one-hour bundle on patient outcomes.

Management information
Registered date
2019 Year 03 Month 29 Day
Last modified on
2019 Year 03 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041412

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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