UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010465 |
|---|---|
| Receipt number | R000012019 |
| Scientific Title | Observational prospective study of treatment for delirium |
| Date of disclosure of the study information | 2013/04/11 |
| Last modified on | 2016/10/12 13:53:18 |
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Basic information
Public title
Observational prospective study of treatment for delirium
Acronym
Observational prospective study of treatment for delirium
Scientific Title
Observational prospective study of treatment for delirium
Scientific Title:Acronym
Observational prospective study of treatment for delirium
Region
| Japan |
Condition
Condition
Patients with delirium
Classification by specialty
| Psychiatry |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To assess the symptoms of delirium by Memorial delirium assessment scale(MDAS)befofe and after intervention for delirium.
Basic objectives2
Others
Basic objectives -Others
To study the association between the improvement factors of MDAS total/sub-score and drugs used for treatment of delirium, retrospectively.
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
The association between the improvement factors of MDAS total/sub-score and drugs used for treatment of delirium
Key secondary outcomes
The association between the improvement factors of MDAS sub-score and pharmacological profiles of drugs used for treatment of delirium
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
1.inpatients
2.delirious patients who treated with single drug
Key exclusion criteria
1.demented patients
2.alcohol withdrawal delirium
3.terminal delirium
4.aphasiac
5.in case of formulation change
6.in case of judging as exclusion by attending doctor
Target sample size
280
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hitoshi Tanimukai |
Organization
Osaka University Hospital
Division name
Oncology Center
Zip code
Address
2-2,Yamadaoka, Suita, Osaka
TEL
06-6879-3051
tanimuki@psy.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hitoshi Tanimukai |
Organization
Osaka University Graduate School of Medicine
Division name
Department of Psychiatry
Zip code
Address
2-2,Yamadaoka, Suita, Osaka
TEL
06-6879-3051
Homepage URL
tanimuki@psy.med.osaka-u.ac.jp
Sponsor or person
Institute
Osaka University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
NOne
Organization
Division
Category of Funding Organization
Other
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
大阪大学医学部附属病院 Osaka University Hospital
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 04 | 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
Trial will be strated from April 1 in 2013.
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
Completed
Date of protocol fixation
| 2013 | Year | 03 | Month | 09 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 04 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
| 2015 | Year | 11 | Month | 30 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Evaluate the clinical symptoms of delirious patients by MDAS.
Management information
Registered date
| 2013 | Year | 04 | Month | 10 | Day |
Last modified on
| 2016 | Year | 10 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012019
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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