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Name
UMIN ID

Recruitment status Completed
Unique ID issued by UMIN UMIN000024565
Receipt No. R000028264
Scientific Title Plasma orexin level in patients with delirium
Date of disclosure of the study information 2016/10/26
Last modified on 2019/04/30

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Basic information
Public title Plasma orexin level in patients with delirium
Acronym Plasma orexin level in patients with delirium
Scientific Title Plasma orexin level in patients with delirium
Scientific Title:Acronym Plasma orexin level in patients with delirium
Region
Japan

Condition
Condition delirium
Classification by specialty
Geriatrics Psychiatry
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To assess the difference in plasma orexin concentration between patients with and without delirium.
Basic objectives2 Others
Basic objectives -Others This study do not perform any pharmacological nor non-pharmacological interventions.
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes Difference in plasma orexin concentration between patients with and without delirium on the two to four hospital day.
Key secondary outcomes 1. Difference in plasma orexin concentration between on early hospital day (day 2 to 4) and on later hospital day (day 10 to 12) in patients with delirium on the early hospital day.
2. Difference in plasma orexin concentration between on early hospital day (day 2 to 4) and on later hospital day (day 10 to 12) in patients without delirium on the early hospital day.

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Diagnosis
Type of intervention
Maneuver
Interventions/Control_1 Obtain 10 mL of blood by venous puncture.
Two time per patient. The first time is on 2nd-4th hospital day, and the second time is 10th-12th hospital day.
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
65 years-old <
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria All inpatients in the geriatric ward in the Nagoya University Hospital.
Key exclusion criteria 1. Patients taking suvorexant (antagonist of orexin receptors).
2. Patients planned to discharge before the 10th hospital day.
Target sample size 70

Research contact person
Name of lead principal investigator
1st name Hirotaka
Middle name
Last name Nakashima
Organization Nagoya University Hospital
Division name Centre for Community Liaison and Patient Consultation
Zip code 466-8560
Address 65 Tsurumai-cho, Showa-ku, Nagoya, Japan
TEL 052-744-1920
Email naka621@med.nagoya-u.ac.jp

Public contact
Name of contact person
1st name Hirotaka
Middle name
Last name Nakashima
Organization Nagoya University Hospital
Division name Centre for Community Liaison and Patient Consultation
Zip code 466-8560
Address 65 Tsurumai-cho, Showa-ku, Nagoya, Japan
TEL 052-744-1920
Homepage URL
Email naka621@med.nagoya-u.ac.jp

Sponsor
Institute Department of Community Healthcare and Geriatrics, Nagoya University Graduate School of Medicine
Institute
Department

Funding Source
Organization Ministry of education
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization the Ethics Committee of Nagoya University Graduate School of Medicine
Address 65 Tsurumai-cho, Showa-ku, Nagoya, Japan
Tel 052-741-2111
Email ethics@med.nagoya-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 名古屋大学医学部附属病院(愛知県)

Other administrative information
Date of disclosure of the study information
2016 Year 10 Month 26 Day

Related information
URL releasing protocol https://onlinelibrary.wiley.com/doi/full/10.1111/psyg.12444
Publication of results Published

Result
URL related to results and publications https://onlinelibrary.wiley.com/doi/full/10.1111/psyg.12444
Number of participants that the trial has enrolled 70
Results Among the 70 patients, 15 (21.4%) was diagnosed as delirium.
There was no significant difference in the levels of orexin-A between patients with and without delirium. Orexin-A levels had no association with delirium severity or delirium subtype. Also, there was no difference in orexin-A levels in patients with delirium before and after amelioration.
Additional analyses revealed that plasma orexin-A levels were negatively correlated with renal function (eGFR and creatinine clearance).
Results date posted
2019 Year 04 Month 30 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
2019 Year 03 Month 19 Day
Baseline Characteristics 84.8 years old on average. Male 35 (50%).
Participant flow On hospital days 2-4, fasting blood was collected in the morning. Delirium was also evaluated at the same time.
Adverse events none
Outcome measures Plasma orexin-A level. Delirium on hospital days 2-4. Severity and subtype of delirium. Renal function (eGFR, reatinine clearance)
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2017 Year 09 Month 15 Day
Date of IRB
2017 Year 09 Month 15 Day
Anticipated trial start date
2017 Year 10 Month 01 Day
Last follow-up date
2018 Year 02 Month 07 Day
Date of closure to data entry
2018 Year 06 Month 30 Day
Date trial data considered complete
2018 Year 06 Month 30 Day
Date analysis concluded
2018 Year 08 Month 31 Day

Other
Other related information Patient recruitment: Hospitalized patients in the geriatric ward in the Nagoya University Hospital who fulfill the inclusion criteria
Recruitment period: From the day the Ethics Committee approves the study to March 31, 2018

Management information
Registered date
2016 Year 10 Month 26 Day
Last modified on
2019 Year 04 Month 30 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028264

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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