UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018427 |
|---|---|
| Receipt number | R000021335 |
| Scientific Title | Investigation of the relationship between orexinergic activity and severity of sepsis in human septic patients |
| Date of disclosure of the study information | 2015/07/27 |
| Last modified on | 2022/01/31 14:44:42 |
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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
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
masuika@hirosaki-u.ac.jp
Sponsor or person
Institute
Hirosaki university
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021335
