UMIN-CTR Clinical Trial

Basic information
Public title	Immunoglobulin correlates with the severity in septic patients
Acronym	Correlation between immunoglobulin and severity of sepsis
Scientific Title	Immunoglobulin correlates with the severity in septic patients
Scientific Title:Acronym	Correlation between immunoglobulin and severity of sepsis
Region	Japan

Condition
Condition	Infection disease/ Sepsis
Classification by specialty	Emergency medicine Intensive care medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Analysis of correlation between the level of serum Ig and the severity in infection disease and sepsis
Basic objectives2	Others
Basic objectives -Others	Analysis of correlation between the level of serum Ig and rapid turnover protein in infection disease and sepsis
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	severity score(SOFA score)
Key secondary outcomes	rapid turnover protein

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	>17 years, hospitalized patients caused by infection
Key exclusion criteria	<18 years
Target sample size	300

Research contact person
Name of lead principal investigator	1st name Shinji Middle name Last name Ogura
Organization	Gifu University Graduate School of Medicine
Division name	Department of emergency and disaster medicine
Zip code	501-1194
Address	1-1 Yanagido, Gifu, Japan
TEL	058-230-6448
Email	oguras@gifu-u.ac.jp

Public contact
Name of contact person	1st name Hideshi Middle name Last name Okada
Organization	Gifu University Graduate School of Medicine
Division name	Department of emergency and disaster medicine
Zip code	5011194
Address	1-1 Yanagido, Gifu, Japan
TEL	058-230-6448
Homepage URL
Email	hideshi@gifu-u.ac.jp

Sponsor
Institute	Department of emergency and disaster medicine, Gifu University Graduate School of Medicine
Institute
Department

Funding Source
Organization	Department of emergency and disaster medicine, Gifu University Graduate School of Medicine
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	The Institutional Review Board for Clinical Research of Gifu University
Address	1-1 Yanagido, Gifu 501-1194, Japan
Tel	058-230-6059
Email	rinri@gifu-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

Other administrative information
Date of disclosure of the study information	2019 Year 06 Month 01 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2016 Year 02 Month 06 Day
Date of IRB	2016 Year 03 Month 02 Day
Anticipated trial start date	2016 Year 03 Month 10 Day
Last follow-up date	2019 Year 06 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	We analize the correlation between the level of serum Ig and severity in infection disease or/and septic patients enrolled between January 2008 and December 2015 retrospectively.

Management information
Registered date	2019 Year 04 Month 01 Day
Last modified on	2020 Year 04 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000041438