UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026350 |
|---|---|
| Receipt number | R000028505 |
| Scientific Title | Evaluation of the intervention for sleep disturbance and delirium prevention in critically ill patients |
| Date of disclosure of the study information | 2017/03/01 |
| Last modified on | 2019/09/02 16:53:19 |
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Basic information
Public title
Evaluation of the intervention for sleep disturbance and delirium prevention in critically ill patients
Acronym
Evaluation of the intervention for sleep disturbance and delirium prevention in critically ill patients
Scientific Title
Evaluation of the intervention for sleep disturbance and delirium prevention in critically ill patients
Scientific Title:Acronym
Evaluation of the intervention for sleep disturbance and delirium prevention in critically ill patients
Region
| Japan |
Condition
Condition
Adult critically ill patients spending 72 hours or more in ICU
Classification by specialty
| Intensive care medicine | Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate sleep structures and association with delirium, usefulness of preventative pharmacological and non-pharmacological interventions for delirium, and feasible sleep assessments in critically ill adult patients.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The incidence of delirium
Key secondary outcomes
Sleep structures, duration days of delirium, ventilator-free days at 28 days, length of stay in ICU, 28-day mortality
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Medicine | Behavior,custom |
Interventions/Control_1
Non-pharmacological sleep promotion bundle
Interventions/Control_2
Medication with 15 or 20mg of suvorexant for the patients who 1)complaints sleepless or 2)takes preoperative hypnotic 3)objectively appears sleepless.
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
Adult critically ill patients spending 72 hours or more in ICU with informed consent
Key exclusion criteria
History of impairments on central nerve system
Postresuscitation from cardiopulmonary arrest
Psychiatric or dementia patients
Alcoholic or drug abuse
Pediatrics younger than 20 years
Positive CAM-ICU on post-operative day 1
Target sample size
160
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kanae NAGATOMO |
Organization
Jichi Medical University Saitama Medical Center
Division name
Anesthesia, Critical and General Surgery
Zip code
Address
1-847 Amanumacho Omiya-ku Saitama-shi, Saitama prefecture
TEL
048-647-2111
nagatomo-cib@umin.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kanae NAGATOMO |
Organization
Jichi Medical University Saitama Medical Center
Division name
Anesthesia, Critical and General Surgery
Zip code
Address
1-847 Amanumacho Omiya-ku Saitama-shi, Saitama prefecture
TEL
048-647-2111
Homepage URL
nagatomo-cib@umin.ac.jp
Sponsor or person
Institute
Jichi Medical University
Institute
Department
Personal name
Funding Source
Organization
Japan Society For The Promotion Of Science
(Grants-in-Aid for Scientific Research)
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
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
| 2017 | Year | 03 | 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
218
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
Completed
Date of protocol fixation
| 2017 | Year | 01 | Month | 26 | Day |
Date of IRB
| 2018 | Year | 03 | Month | 23 | Day |
Anticipated trial start date
| 2017 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 03 | Month | 01 | Day |
Last modified on
| 2019 | Year | 09 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028505
| Research Plan | |
|---|---|
| Registered date | File name |
| 2019/09/02 | 研究計画書2.13.doc |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
