UMIN-CTR Clinical Trial

Basic information
Public title	A study on the validity of an algorithm for predicting severity of illness (SOFA score) after 24 hours in the intensive care unit
Acronym	A study on the validity of an algorithm for predicting severity of illness (SOFA score) after 24 hours in the intensive care unit
Scientific Title	A study on the validity of an algorithm for predicting severity of illness (SOFA score) after 24 hours in the intensive care unit
Scientific Title:Acronym	A study on the validity of an algorithm for predicting severity of illness (SOFA score) after 24 hours in the intensive care unit
Region	Japan

Condition
Condition	Clitical care
Classification by specialty	Intensive care medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The ACE system/app developed by Peach IntelliHealth is a machine learning-based early patient condition prediction and warning system in an English language environment that uses electronic patient record data to predict the probability of developing Systemic Inflammatory Response Syndrome (SIRS), platelet count, and use of circulatory agonists, including the degree of organ damage (SOFA score) at 12-24 hours. It predicts the probability of developing Systemic Inflammatory Response Syndrome (SIRS), platelet count, and use of circulatory agonists, including the degree of organ damage (SOFA score) after 12-24 hours, from electronic patient record data. In this study, we will investigate whether the Sequential Organ Failure Assessment Score (SOFA) score at 24 hours can be predicted by the ACE system using historical electronic data of patients admitted to our ICU.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Comparison of predicted SOFA score and actual SOFA score after 24 hours
Key secondary outcomes	The ability of prediction of SIRS score, need for vasopressors, sepsis

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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients admitted to the ICU during the period from July 31, 2017 to February 1, 2021.
Key exclusion criteria	none
Target sample size	7500

Research contact person
Name of lead principal investigator	1st name Yusuke Middle name Last name Iizuka
Organization	Saitama medical center, Jichi medical university
Division name	department of critical care and anesthesiology
Zip code	3308503
Address	1-847 Amanuma town, Omiya Ku, Saitama City, Saitama
TEL	+81486472111
Email	yiizuka@jichi.ac.jp

Public contact
Name of contact person	1st name Yusuke Middle name Last name Iizuka
Organization	Saitama medical center, Jichi medical university
Division name	department of critical care and anesthesiology
Zip code	3308503
Address	1-847 Amanuma town, Omiya Ku, Saitama City, Saitama
TEL	+81486472111
Homepage URL
Email	yiizuka@jichi.ac.jp

Sponsor
Institute	Jichi medical university
Institute
Department

Funding Source
Organization	Ministry of Health and Welfare
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Jichi medical university, saitama medical center
Address	1-847 Amanuma town, Omiya Ku, Saitama City, Saitama
Tel	+81486472111
Email	yiizuka@jichi.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	2022 Year 02 Month 07 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	2022 Year 01 Month 19 Day
Date of IRB	2022 Year 01 Month 19 Day
Anticipated trial start date	2022 Year 01 Month 19 Day
Last follow-up date	2022 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	none

Management information
Registered date	2022 Year 02 Month 07 Day
Last modified on	2022 Year 08 Month 15 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053446