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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000039993
Receipt No. R000045596
Scientific Title Evaluation of early warning scores for prediction of mortality in patients with being activated medical emergency team call
Date of disclosure of the study information 2020/04/01
Last modified on 2020/03/31

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Basic information
Public title Evaluation of early warning scores for prediction of mortality in patients with being activated medical emergency team call
Acronym Evaluation of early warning scores for prediction of mortality in patients with being activated medical emergency team call
Scientific Title Evaluation of early warning scores for prediction of mortality in patients with being activated medical emergency team call
Scientific Title:Acronym Evaluation of early warning scores for prediction of mortality in patients with being activated medical emergency team call
Region
Japan

Condition
Condition patients who are activated medical emergency team (MET) call during hospitalization.
Classification by specialty
Intensive care medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Evaluation of the efficacies of MEWS, NEWS and REMS, and APACHE II score on unplanned ICU admission and 28-day mortality in patients who are activated medical emergency team (MET) call during hospitalization.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Evaluation of early warning scores and APACHE II score for prediction of mortality in patients with being activated medical emergency team call
Key secondary outcomes

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
200 years-old >=
Gender Male and Female
Key inclusion criteria In patients who are activated MET call after track and triggering of clinical deterioration in the general ward during the period between April 2013 to March 2019 were enrolled in this study.
Key exclusion criteria Patients who were under 18 years of age and patients in whom vital signs at activation of MET call was not determined and not observed for evaluation of early warning scores that were used in this study were excluded.
Target sample size 400

Research contact person
Name of lead principal investigator
1st name Hiroomi
Middle name
Last name Tatsumi
Organization Sapporo medical University
Division name Department of Intensive Care Medicine
Zip code 064-8543
Address South-1, West-16, Chuo-ku, Sapporo, Hokkaido, 060-8543 Japan
TEL +81-11-611-2111
Email jp.haruna@hotmail.co.jp

Public contact
Name of contact person
1st name JUNPEI
Middle name
Last name HARUNA
Organization Sapporo Medical University, School of Medicine
Division name Department of Intensive Care Medicine
Zip code 064-8543
Address South-1, West-16, Chuo-ku, Sapporo, Hokkaido, 060-8543 Japan
TEL +81-11-611-2111
Homepage URL http://sapmedicu.com/
Email jp.haruna@hotmail.co.jp

Sponsor
Institute Sapporo Medical University
Institute
Department

Funding Source
Organization Self-funding
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Sapporo Medical University
Address South-1, West-16, Chuo-ku, Sapporo
Tel 011-611-2111(+81-11-611-2111)
Email jp.haruna@hotmail.co.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 札幌医科大学附属病院
Sapporo Medical University Hospital

Other administrative information
Date of disclosure of the study information
2020 Year 04 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 06 Month 01 Day
Date of IRB
2019 Year 05 Month 13 Day
Anticipated trial start date
2019 Year 06 Month 01 Day
Last follow-up date
2020 Year 07 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Non

Management information
Registered date
2020 Year 03 Month 31 Day
Last modified on
2020 Year 03 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045596

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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