UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039996 |
|---|---|
| Receipt number | R000045605 |
| Scientific Title | Evaluation of sleep stage analysis using a simplified electroencephalograph and the relationship between sleep-related hormones and sleep stages in critically ill patients with sepsis |
| Date of disclosure of the study information | 2020/04/01 |
| Last modified on | 2020/03/31 10:59:56 |
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Basic information
Public title
Evaluation of sleep stage analysis using a simplified electroencephalograph and the relationship between sleep-related hormones and sleep stages in critically ill patients with sepsis
Acronym
Evaluation of sleep stage analysis using a simplified electroencephalograph and the relationship between sleep-related hormones and sleep stages in critically ill patients with sepsis
Scientific Title
Evaluation of sleep stage analysis using a simplified electroencephalograph and the relationship between sleep-related hormones and sleep stages in critically ill patients with sepsis
Scientific Title:Acronym
Evaluation of sleep stage analysis using a simplified electroencephalograph and the relationship between sleep-related hormones and sleep stages in critically ill patients with sepsis
Region
| Japan |
Condition
Condition
Patients who agreement with Sepsis-3 criteria
Classification by specialty
| Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to evaluate the usefulness of a simplified electroencephalograph for monitoring sleep electroencephalogram in patients with sepsis.
The purpose of this study is to clarify the changes of humoral mechanism in patients with sepsis.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Agreement rate between PSG and EEG sensor ZA-X score in patients with sepsis
Rhythmic changes in blood melatonin and orexin concentrations in patients with sepsis and their relationship with sleep EEG
Key secondary outcomes
Relationship between blood melatonin concentration, blood orexin concentration and delirium
Relationship between sleep efficiency and mortality
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
| 200 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients 18 years and older who agreement the Sepsis-3 criteria requiring invasive ventilation management in the ICU
Key exclusion criteria
We excluded the following patients:
1)History of apparent central nervous system disease (stroke, head injury, central nervous system infection, brain tumor, after brain surgery, after cardiopulmonary arrest resuscitation, etc.)
2)History of psychiatric disorders / dementia
3)Alcohol and other poisoning patients
4)tracheotomy patient
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Hiroomi |
| Middle name | |
| Last name | Tatsumi |
Organization
Sapporo Medical University
Division name
Department of Intensive Care Medicine
Zip code
064-8543
Address
South-1, West-16, Chuo-ku, Sapporo, Hokkaido, 060-8543 Japan
TEL
+81-11-611-2111
jp.haruna@hotmail.co.jp
Public contact
Name of contact person
| 1st name | JUNPEI |
| Middle name | |
| Last name | HARUNA |
Organization
Sapporo Medical University, School of Medicine.
Division name
Department of Intensive Care Medicine
Zip code
064-8543
Address
South-1, West-16, Chuo-ku, Sapporo, Hokkaido, 060-8543 Japan
TEL
+81-11-611-2111
Homepage URL
http://sapmedicu.com/
jp.haruna@hotmail.co.jp
Sponsor or person
Institute
Sapporo Medical University
Institute
Department
Personal name
Funding Source
Organization
Self funding
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
Sapporo Medical University
Address
South-1, West-16, Chuo-ku, Sapporo, Hokkaido, 060-8543 Japan
Tel
+81-11-611-2111
jp.haruna@hotmail.co.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
| 2020 | Year | 04 | 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
Open public recruiting
Date of protocol fixation
| 2020 | Year | 02 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 10 | Month | 01 | Day |
Anticipated trial start date
| 2020 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Non
Management information
Registered date
| 2020 | Year | 03 | Month | 31 | Day |
Last modified on
| 2020 | Year | 03 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045605
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
