UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046846 |
|---|---|
| Receipt number | R000053446 |
| 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 |
| Date of disclosure of the study information | 2022/02/07 |
| Last modified on | 2022/08/15 22:58:12 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
yiizuka@jichi.ac.jp
Sponsor or person
Institute
Jichi medical university
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053446
