UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042518 |
|---|---|
| Receipt number | 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 18:24:58 |
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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
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
hsmdfacp@jichi.ac.jp
Sponsor or person
Institute
Jichi Medical University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048533
