UMIN-CTR Clinical Trial

Basic information
Public title	Evaluation of early warning scores for prediction of sepsis in patients with being unplanned ICU admission
Acronym	Evaluation of early warning scores for prediction of sepsis in patients with being unplanned ICU admission
Scientific Title	Evaluation of early warning scores for prediction of sepsis in patients with being unplanned ICU admission
Scientific Title:Acronym	Evaluation of early warning scores for prediction of sepsis in patients with being unplanned ICU admission
Region	Japan

Condition
Condition	Patients who are unplanned ICU admission
Classification by specialty	Intensive care medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Evaluation of the efficacies of Early Warning score on prediction of sepsis in patients who are unplanned ICU admission.
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 sepsis in patients who are unplanned ICU admission.
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 unplanned ICU admission during the period between April 2011 to December 2019 were enrolled in this study.
Key exclusion criteria	Patients who were under 18 years of age and patients in whom vital signs at ICU admission was not determined and not observed for evaluation of early warning scores that were used in this study were excluded.
Target sample size	2000

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	064-0821
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, Hokkaido, 060-8543 Japan
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

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	2020 Year 03 Month 20 Day
Date of IRB	2020 Year 03 Month 11 Day
Anticipated trial start date	2020 Year 03 Month 20 Day
Last follow-up date	2022 Year 11 Month 30 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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000045606