UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000024565
Receipt number 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 17:20:00

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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 or person

Institute

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

Institute

Department

Personal name



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

Value
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