UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000030037
Receipt number R000034213
Scientific Title Histidine-Rich Glycoprotein as a novel severity biomarker for sepsis: application to early treatment
Date of disclosure of the study information 2018/02/01
Last modified on 2023/05/26 17:02:44

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Basic information

Public title

Histidine-Rich Glycoprotein as a novel severity biomarker for sepsis: application to early treatment

Acronym

HRG as a novel severity biomarker for sepsis

Scientific Title

Histidine-Rich Glycoprotein as a novel severity biomarker for sepsis: application to early treatment

Scientific Title:Acronym

HRG as a novel severity biomarker for sepsis

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 focus on the HRG levels in patients with sepsis, and assess the significance of the difference between HRG levels in non-survivors and survivors.

Basic objectives2

Others

Basic objectives -Others

Biological significance

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

We confirm the time change of HRG levels in patients with sepsis, and examine the association with a clinical course and a prognosis.

Key secondary outcomes

We examine the change of HRG levels by the cause of 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

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Patients newly diagnosed sepsis: Sepsis is defined as life-threatening organ dysfunction caused by a dysregulated host response to infection, and organ dysfunction can be identified as an acute change in total SOFA score 2 points or more consequent to the infection.

Key exclusion criteria

Pregnancy and Under 20 years old

Target sample size

200


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

086-235-7327

Email

pb9b45wr@okayama-u.ac.jp


Public contact

Name of contact person

1st name Naoya
Middle name
Last name Kawanoue

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

086-235-7327

Homepage URL


Email

nao.kawa@s.okayama-u.ac.jp


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

Japan Agency for Medical Research and Development

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

Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences and Okayama University Hospital, Ethics Committee

Address

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

Tel

086-235-6938

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)
島根大学医学部附属病院(島根県)
鳥取大学医学部附属病院(鳥取県)
愛媛大学医学部附属病院(愛媛県)
香川大学医学部附属病院(香川県)
岡山医療センター(岡山県)
岡山済生会総合病院(岡山県)
岡山市立市民病院(岡山県)
岡山赤十字病院(岡山県)
川崎医科大学総合医療センター(岡山県)
津山中央病院(岡山県)
福山医療センター(広島県)
福山市民病院(広島県)
尾道市立市民病院(広島県)
香川県立中央病院(香川県)
香川労災病院(香川県)
姫路赤十字病院(兵庫県)
神戸赤十字病院(兵庫県)


Other administrative information

Date of disclosure of the study information

2018 Year 02 Month 01 Day


Related information

URL releasing protocol

http://www.okadaimasui.com/jp/

Publication of results

Published


Result

URL related to results and publications

https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0283426

Number of participants that the trial has enrolled

201

Results

Although there was no time x survivors/non-survivors interaction in the time courses of HRG (P=0.34), the main effect of generalized linear mixed models was significant (P<0.001).
In a univariate Cox proportional hazards model with each variable as a time-dependent covariate, higher HRG levels were significantly associated with a lower risk of mortality (hazard ratio, 0.85 [95%CI, 0.78-0.92]; P<0.001).

Results date posted

2023 Year 05 Month 26 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results

2023 Year 03 Month 29 Day

Baseline Characteristics

Patients with sepsis

Participant flow

Patients newly diagnosed with sepsis based on the Sepsis-3 definition were prospectively enrolled in the study. The inclusion criteria included admission to the ICU with an increase in the SOFA score by 2 points or more caused by a dysregulated host response to infection.
After obtaining written consent from patients or their relatives, blood samples were collected to be analyzed later for HRG, P-SEP, and PCT levels on days 1 (within 24 h of diagnosis of sepsis), 3, 5, and 7, while the patients stayed in the ICU.

Adverse events

None

Outcome measures

The primary outcome of this study was all-cause mortality within 28 days of the initial sampling. The differences in the time courses of HRG levels between survivors and non-survivors were evaluated.

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2018 Year 02 Month 01 Day

Date of IRB

2018 Year 04 Month 24 Day

Anticipated trial start date

2018 Year 08 Month 16 Day

Last follow-up date

2019 Year 12 Month 19 Day

Date of closure to data entry

2020 Year 09 Month 30 Day

Date trial data considered complete

2020 Year 12 Month 31 Day

Date analysis concluded

2021 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

2017 Year 11 Month 20 Day

Last modified on

2023 Year 05 Month 26 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034213


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name