UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036349 |
|---|---|
| Receipt number | 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 20:41:04 |
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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
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
editorial-jaam@umin.net
Sponsor or person
Institute
Japanese Association for Acute Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041412
