UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039993 |
|---|---|
| Receipt number | 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 | 2022/06/09 09:26:36 |
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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
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/
jp.haruna@hotmail.co.jp
Sponsor or person
Institute
Sapporo Medical University
Institute
Department
Personal name
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)
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
Completed
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
| 2022 | Year | 06 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045596
