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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000020387
Receipt No. 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

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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
Email 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
Email shun.yanai.md@gmail.com

Sponsor
Institute Toho University
Institute
Department

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
Email 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
URL(English) https://upload.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


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