UMIN-CTR Clinical Trial

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

Patients with C-reactive protein levels out of40 mg/dL

Classification by specialty

Medicine in general

Classification by malignancy

Others

Genomic information

NO

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

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

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Jichi Medical University

Institute

Department

Personal name

Organization

JSPS KAKENHI (Grant Number: 26460916)

Organization

Division

Category of Funding Organization

Non profit foundation

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

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

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2020

Year

11

Month

21

Day

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

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

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 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)]

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