UMIN-CTR Clinical Trial

Basic information
Public title	Investigation of the relationship between orexinergic activity and severity of sepsis in human septic patients
Acronym	Measurement of blood Orexin in the patients of sepsis
Scientific Title	Investigation of the relationship between orexinergic activity and severity of sepsis in human septic patients
Scientific Title:Acronym	Measurement of blood Orexin in the patients of sepsis
Region	Japan

Condition
Condition	Sepsis
Classification by specialty	Anesthesiology Intensive care medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	It was suggested that the orexinergic activity was decreased in septic state in animal models. Therefore, the aim of this is to evaluate the relationship between the orexinergic activity and sepsis in human.
Basic objectives2	Others
Basic objectives -Others	We investigate the relationships between blood orexin levels and the septic markers and between blood orexin levels and septic severity.
Trial characteristics_1
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	Comparison of blood orexin A levels between septic patients and non-septic patients
Key secondary outcomes	Investigation of the relationships between blood orexin levels and the septic markers and between blood orexin levels and septic severity.

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	Septic patients
Key exclusion criteria	Patients consent could not be obtained.
Target sample size	60

Research contact person
Name of lead principal investigator	1st name Eiji Middle name Last name Hashiba
Organization	Division of intensive care, Hirosaki university hospital
Division name	Department of anesthesiology
Zip code	036
Address	5 Zaifu-cho, Hirosaki city, Aomori prefecture
TEL	+81-172-39-5113
Email	ehashiba@hirosaki-u.ac.jp

Public contact
Name of contact person	1st name Masahiro Middle name Last name Akaishi
Organization	Hirosaki university Postgraduate School of Medicine
Division name	Department of anesthesiology
Zip code	036
Address	5 Zaifu-cho, Hirosaki city, Aomori prefecture
TEL	+81-172-39-5113
Homepage URL
Email	masuika@hirosaki-u.ac.jp

Sponsor
Institute	Hirosaki university
Institute
Department

Funding Source
Organization	The Ministry of Education,Culuture,Sports,Science and Technology.
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	Hirosaki university
Address	5 Zaifu-cho, Hirosaki city, Aomori prefecture
Tel	+81-172-39-5113
Email	cksenta@hirosaki-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	弘前大学医学部附属病院(青森県)(Hirosaki University Hospital)

Other administrative information
Date of disclosure of the study information	2015 Year 07 Month 27 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	57
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	No longer recruiting
Date of protocol fixation	2014 Year 11 Month 16 Day
Date of IRB	2015 Year 08 Month 01 Day
Anticipated trial start date	2015 Year 08 Month 01 Day
Last follow-up date	2022 Year 01 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	On progress

Management information
Registered date	2015 Year 07 Month 27 Day
Last modified on	2022 Year 01 Month 31 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000021335