UMIN-CTR Clinical Trial

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

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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020455