UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024796 |
|---|---|
| Receipt number | R000028529 |
| Scientific Title | Evaluation of po suvorexant for delirium in ICU ventilated patients |
| Date of disclosure of the study information | 2016/11/11 |
| Last modified on | 2017/11/22 14:27:46 |
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Basic information
Public title
Evaluation of po suvorexant for delirium in ICU ventilated patients
Acronym
Evaluation of po suvorexant in ICU patients
Scientific Title
Evaluation of po suvorexant for delirium in ICU ventilated patients
Scientific Title:Acronym
Evaluation of po suvorexant in ICU patients
Region
| Japan |
Condition
Condition
insomnia
Classification by specialty
| Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the efficacy and safety of administration of suvorexant via gastric tube in ICU.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I
Assessment
Primary outcomes
frequency of insomnia, dose of sedative agents
Key secondary outcomes
frequency of delirium, dose of vasopressor
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Administration of suborexant via gastric tube(half dose)
Interventions/Control_2
Administration of suborexant via gastric tube
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
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patient who need mechanical ventilation and expected to stay ICU for 24 hours
Key exclusion criteria
･Severe liver disfunction
･Patient who need continuous sedation throughout day
･Gastrointestinal dysfunction
Target sample size
12
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kansuke Koyama |
Organization
Jichi Medical University hospital
Division name
Department of Anesthesiology and Intensive care Medicine
Zip code
Address
3311-1 Yakushiji Shimotsuke-shi, Tochigi
TEL
0285-58-7392
k_koyama@jichi.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kansuke Koyama |
Organization
Jichi Medical University hospital
Division name
Department of Anesthesiology and Intensive care Medicine
Zip code
Address
3311-1 Yakushiji Shimotsuke-shi, Tochigi
TEL
0285-58-7392
Homepage URL
k_koyama@jichi.ac.jp
Sponsor or person
Institute
Jichi Medical university hospital
Institute
Department
Personal name
Funding Source
Organization
Jichi Medical university hospital
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
Address
Tel
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
| 2016 | Year | 11 | Month | 11 | 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
Preinitiation
Date of protocol fixation
| 2016 | Year | 11 | Month | 11 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 11 | Month | 14 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 11 | Month | 11 | Day |
Last modified on
| 2017 | Year | 11 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028529
| 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 |
