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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000042518
Receipt No. R000048533
Scientific Title Prediction of 72-hour mortality in patients with extremely high serum C-reactive protein levels using a novel weighted average of risk scores
Date of disclosure of the study information 2020/11/21
Last modified on 2020/11/21

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Basic information
Public title Prediction of 72-hour mortality in patients with extremely high serum C-reactive protein levels using a novel weighted average of risk scores
Acronym Prediction of 72-hour mortality in patients with extremely high serum C-reactive protein levels using a novel weighted average of risk scores
Scientific Title Prediction of 72-hour mortality in patients with extremely high serum C-reactive protein levels using a novel weighted average of risk scores
Scientific Title:Acronym Prediction of 72-hour mortality in patients with extremely high serum C-reactive protein levels using a novel weighted average of risk scores
Region
Japan

Condition
Condition Patients with C-reactive protein levels out of40 mg/dL
Classification by specialty
Medicine in general
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We aimed to elucidate the risk variables for predicting 72-hour mortality among patients with extremely high CRP levels under heterogeneous pathological conditions.
Basic objectives2 Others
Basic objectives -Others We primarily applied multivariate logistic regression analysis to explore the variables for predicting mortality. Furthermore, we devised a flexible method of predicting mortality by using a novel score, called weighted average of risk scores as an alternative approach.
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes The primary outcome was 72-hour mortality following the CRP test, regardless of whether the patient was hospitalized or in an outpatient setting.
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

Not applicable
Gender Male and Female
Key inclusion criteria Patients with very high serum C-reactive protein levels out of 40 mg/dL
Key exclusion criteria We excluded 113 records metachronous duplicates from the same patient (only one highest value of CRP from each of these patients was considered), cardiopulmonary arrest at arrival, and unknown outcomes.
Target sample size 275

Research contact person
Name of lead principal investigator
1st name Hitoshi
Middle name
Last name Sugawara
Organization Saitama Medical Center, Jichi Medical University
Division name Division of General Medicine, Department of Comprehensive Medicine 1
Zip code 3308503
Address 1-847, Amanuma, Omiya, Saitama, Saitama, Japan
TEL +81486472111
Email hsmdfacp@jichi.ac.jp

Public contact
Name of contact person
1st name Hitoshi
Middle name
Last name Sugawara
Organization Saitama Medical Center, Jichi Medical University
Division name Division of General Medicine, Department of Comprehensive Medicine 1
Zip code 3308503
Address 1-847, Amanuma, Omiya, Saitama, Saitama, Japan
TEL +81486472111
Homepage URL
Email hsmdfacp@jichi.ac.jp

Sponsor
Institute Jichi Medical University
Institute
Department

Funding Source
Organization JSPS KAKENHI (Grant Number: 26460916)
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Saitama Medical Center, Jichi Medical University
Address 1-847, Amanuma, Omiya, Saitama, Saitama, Japan
Tel 0486472111
Email m.kuroda@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
2020 Year 11 Month 21 Day

Related information
URL releasing protocol https://www.jichi.ac.jp/center/sinryoka/n_sougou/%E7%A0%94%E7%A9%B6%E6%88%90%E6%9E%9C%E5%A0%B1%E5%91
Publication of results Partially published

Result
URL related to results and publications https://www.jichi.ac.jp/center/sinryoka/n_sougou/%E7%A0%94%E7%A9%B6%E6%88%90%E6%9E%9C%E5%A0%B1%E5%91
Number of participants that the trial has enrolled 275
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
2020 Year 04 Month 01 Day
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 06 Month 11 Day
Date of IRB
2020 Year 06 Month 11 Day
Anticipated trial start date
2020 Year 06 Month 11 Day
Last follow-up date
2020 Year 11 Month 21 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information MLRA using Dataset-A (n = 275; 44 dead, 231 alive) was performed to determine a regression model for predicting 72-hour mortality. An optimal regression model was derived by stepwise selection of risk variables, which consisted of four risk variables: age, albumin, inorganic phosphate, and CVD as follows:
p = 1/[1+exp(-4.97+0.058(age)-0.853(ALB)+0.615(IP0.5)+1.498(CVD)]

Management information
Registered date
2020 Year 11 Month 21 Day
Last modified on
2020 Year 11 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048533

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name
2020/11/21 CRP_Medication_2004_2017_UMIN.xlsx


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