UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020387 |
|---|---|
| Receipt number | R000020814 |
| Scientific Title | Establishment of appropriate termination method of dexmedetomidine in pediatric patients |
| Date of disclosure of the study information | 2016/01/01 |
| Last modified on | 2019/06/30 17:27:56 |
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Basic information
Public title
Establishment of appropriate termination method of dexmedetomidine in pediatric patients
Acronym
Establishment of appropriate termination method of dexmedetomidine in pediatric patients
Scientific Title
Establishment of appropriate termination method of dexmedetomidine in pediatric patients
Scientific Title:Acronym
Establishment of appropriate termination method of dexmedetomidine in pediatric patients
Region
| Japan |
Condition
Condition
All pediatric patients aged 15 years and under given dexmedetomidine in their treatment corse
Classification by specialty
| Cardiology | Neurology | Pediatrics |
| Anesthesiology | Emergency medicine | Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To confirm efficacy of gradual weaning of dexmedetomidine as a means to prevent dexmedetomidine withdrawal syndrome
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Prevalence of dexmedetomidine withdrawal syndrome within 6 hours after discontinuation of dexmedetomidine based on abnormal vital signs and sedation scores
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Change termination process of dexmedetomidine administration from sudden termination to gradual weaning.
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
| Not applicable |
Age-upper limit
| 15 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
All pediatric patients who are scheduled to receive intravenous administration of dexmedetomidine either in Intensive Care Unite (ICU), Operation Room (OR), or Ward with written consent by their guardians.
Key exclusion criteria
In case participation to the research was declined or withdrawn by guardians.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Shun |
| Middle name | |
| Last name | Yanai |
Organization
Toho University Omori Medical Center
Division name
Department of Pediatrics
Zip code
143-8541
Address
6-11-1, Omori-Nishi, Ota-ku, Tokyo
TEL
03-3762-4151
shun.yanai.md@gmail.com
Public contact
Name of contact person
| 1st name | Shun |
| Middle name | |
| Last name | Yanai |
Organization
Toho University Omori Medical Center
Division name
Department of Pediatrics
Zip code
143-8541
Address
6-11-1, Omori-nishi, Ota-ku, Tokyo
TEL
03-3762-4151
Homepage URL
shun.yanai.md@gmail.com
Sponsor or person
Institute
Toho University
Institute
Department
Personal name
Funding Source
Organization
Toho University
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
Toho University Omori Medical Center
Address
6-11-1, Omori-nishi, Ota-ku, Tokyo
Tel
03-3762-4151
shun.yanai.md@gmail.com
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
東邦大学医療センター大森病院
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 01 | 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
Results
As of December 31, 2017, 56 patients have participated in the program, whereas 46 patients have completed the research intervention. Among those participants, two cases have died of exacerbation of underlying condition before planned intervention was initiated.
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
| 2016 | Year | 01 | Month | 01 | Day |
Date of IRB
| 2016 | Year | 03 | Month | 15 | Day |
Anticipated trial start date
| 2016 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2018 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2018 | Year | 03 | Month | 31 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 12 | Month | 28 | Day |
Last modified on
| 2019 | Year | 06 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020814
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
