UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000017651
Receipt number R000020455
Scientific Title Histidine-Rich Glycoprotein as a Novel Prognostic Biomarker in Septic Patients: Prospective Observational Study
Date of disclosure of the study information 2015/05/22
Last modified on 2021/05/25 12:30:35

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Basic information

Public title

Histidine-Rich Glycoprotein as a Novel Prognostic Biomarker in Septic Patients: Prospective Observational Study

Acronym

HRG-Observational

Scientific Title

Histidine-Rich Glycoprotein as a Novel Prognostic Biomarker in Septic Patients: Prospective Observational Study

Scientific Title:Acronym

HRG-Observational

Region

Japan


Condition

Condition

Sepsis

Classification by specialty

Infectious disease Laboratory medicine Emergency medicine
Intensive care medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

We measure HRG levels in septic patients and assess the HRG as a biomarker.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Relation between the HRG levels and mortality

Key secondary outcomes

Relations between the HRG levels and other parameters


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

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Patients newly diagnosed sepsis.

Key exclusion criteria

Pregnancy and Patients with transplantation

Target sample size

100


Research contact person

Name of lead principal investigator

1st name Hiroshi
Middle name
Last name Morimatsu

Organization

Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences

Division name

Department of Anesthesiology and Resuscitology

Zip code

700-8558

Address

2-5-1 Shikatacho, Kitaku, Okayama, Japan

TEL

+81-86-235-7327

Email

pb9b45wr@okayama-u.ac.jp


Public contact

Name of contact person

1st name Kosuke
Middle name
Last name Kuroda

Organization

Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences

Division name

Department of Anesthesiology and Resuscitology

Zip code

700-8558

Address

2-5-1 Shikatacho, Kitaku, Okayama, Japan

TEL

+81-86-235-7327

Homepage URL

http://www.okadaimasui.com/

Email

kosa-tym@umin.net


Sponsor or person

Institute

Department of Anesthesiology and Resuscitology, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences

Institute

Department

Personal name



Funding Source

Organization

Scientific Research from the Ministry of Health, Labor, and Welfare of Japan

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Institutional Review Board of the Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences

Address

2-5-1 Shikatacho, Kitaku, Okayama, Japan

Tel

086-235-6503

Email

mae6605@adm.okayama-u.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

岡山大学病院(岡山県)
川崎医科大学附属病院(岡山県)
川崎医科大学附属川崎病院(岡山県)
岡山医療センター(岡山県)
岡山市民病院(岡山県)
岡山済生会病院(岡山県)
津山中央病院(岡山県)
広島市民病院(広島県)
福山医療センター(広島県)
福山市民病院(広島県)
姫路赤十字病院(兵庫県)
香川県立中央病院(香川県)
香川労災病院(香川県)
高知医療センター(高知県)


Other administrative information

Date of disclosure of the study information

2015 Year 05 Month 22 Day


Related information

URL releasing protocol

http://www.okadaimasui.com/

Publication of results

Published


Result

URL related to results and publications

www.nature.com/articles/s41598-021-89555-z

Number of participants that the trial has enrolled

101

Results

HRG levels were significantly lower in non-survivors (n = 16) than in survivors (n = 83) (median, 15.1 [IQR, 12.7-16.6] vs. 30.6 [22.1- 39.6] mcg/ml; p < 0.01). Survival analysis revealed that HRG levels were associated with mortality (hazard ratio 0.79, p < 0.01).

Results date posted

2021 Year 05 Month 25 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

Sepsis

Participant flow

The inclusion criteria were patients admitted to the ICU and the occurrence of sepsis. After obtaining written informed consent for participation from the patients or their relatives, blood samples were collected.

Adverse events

Non

Outcome measures

The primary outcome was HRG levels in survivors and non-survivors.

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2014 Year 10 Month 01 Day

Date of IRB

2014 Year 09 Month 30 Day

Anticipated trial start date

2014 Year 10 Month 01 Day

Last follow-up date

2017 Year 03 Month 31 Day

Date of closure to data entry

2017 Year 03 Month 31 Day

Date trial data considered complete

2017 Year 03 Month 31 Day

Date analysis concluded

2017 Year 06 Month 30 Day


Other

Other related information

In the preliminary study, we found that the HRG levels in SIRS patients were significantly low.


Management information

Registered date

2015 Year 05 Month 22 Day

Last modified on

2021 Year 05 Month 25 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020455


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name