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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000009115
Receipt No. R000010690
Scientific Title The measurement of dexmedetomidine for sedation in intensive care patients
Date of disclosure of the study information 2012/10/15
Last modified on 2018/06/08

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Basic information
Public title The measurement of dexmedetomidine for sedation in intensive care patients
Acronym The measurement of dexmedetomidine in intensive care patients
Scientific Title The measurement of dexmedetomidine for sedation in intensive care patients
Scientific Title:Acronym The measurement of dexmedetomidine in intensive care patients
Region
Japan

Condition
Condition Intensive care patients
Classification by specialty
Intensive care medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To assess the plasma concentration of dexmedetomidine and its sedative effect of the patients
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes To investigate the relation between the plasma level of dexmedetomidine and the method of administering dexmedetomidine
Key secondary outcomes To assess the sedative effect with the plasma level of dexmedetomidine

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 Treatment
Type of intervention
Medicine
Interventions/Control_1 Dexmedetomidine is administered for sedation in intensive care patients
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

Not applicable
Gender Male and Female
Key inclusion criteria Intensive care patients
Key exclusion criteria BMI>35 or BMI <17
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshihito Fujita
Organization Nagoya City University Graduate School of Medical Sciences
Division name Department of Anesthesiology and Medical Crisis Management
Zip code
Address 1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya
TEL 052-851-5511
Email masui@med.nagoya-cu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yoshihito Fujita
Organization Nagoya City University Graduate School of Medical Sciences
Division name Department of Anesthesiology and Medical Crisis Management
Zip code
Address 1 kawasumi mizuho-cho mizuho-ku, Nagoya City
TEL 052-851-5511
Homepage URL
Email masui@med.nagoya-cu.ac.jp

Sponsor
Institute Nagoya City University Graduate School of Medical Sciences
Institute
Department

Funding Source
Organization Nagoya City University Graduate School of Medical Sciences
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor Laboratory of Analytical and Bio-Analytical Chemistry, School of Pharmaceutical Science, University of Shizuoka
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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 名古屋市立大学病院(愛知県)

Other administrative information
Date of disclosure of the study information
2012 Year 10 Month 15 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications https://www.ekja.org/DOIx.php?id=10.4097/kjae.2017.70.4.426
Number of participants that the trial has enrolled
Results In adults, Background. There is little information about the relationship between dose and plasma concentration of dexmedetomidine DEX in critically ill patients. Methods. Plasma DEX concentrations of 67 samples from 34 patients in an intensive care unit were measured and the correlation coefficient between dose and plasma concentration was estimated. Results. Among the patients, 20, 58.8 percent, of the 34 received DEX at 0.20 0.83 micro g kg h, and in 40 of the 67 samples for which DEX had been administered, this occurred for a median duration of 18.5 h, range, 3 87 h. The range of the DEX plasma concentration was 0.22 2.50 ng ml. The plasma DEX concentration was moderately correlated with the administered dose, r 0.653, P less than 0.01. The approximate linear equation was Y 0.171X 0.254. The range of Richmond Agitation-Sedation Scale was 0 to minus 5. Conclusions. We concluded that, with a dosage of 0.2 0.83 micro g kg h, the patients in this setting could obtain an effective DEX concentration of 0.22 2.50 ng ml. In addition, the plasma DEX concentration was moderately correlated with the administered dose, r 0.653, P less than 0.01.
In infant, Methods. All patients admitted to our PICU for 5 months were eligible for inclusion in the study. Results. We measured the plasma DEX concentration in 203 samples from 45 patients. Of these, 96 samples collected from 27 patients less than 2 years old were included in this study. All patients received DEX at 0.12 1.40 micro g kg h. The median administration duration was 87.6 hours, range 6 540 hours. Plasma DEX concentration ranged from 0.07 to 3.17 ng m and was not correlated with the administered dose, r 0.273, P 0.007. Conclusions. In infants, plasma DEX concentration did not exhibit any correlation with administered dose, which is not a reliable means of obtaining optimal plasma concentration.
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
2012 Year 10 Month 01 Day
Date of IRB
Anticipated trial start date
2012 Year 10 Month 16 Day
Last follow-up date
2016 Year 01 Month 20 Day
Date of closure to data entry
2016 Year 01 Month 20 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information In adults, Journal of Intensive Care, 2013, 1, 15.
In infants, Korean Journal of Anesthesiology, 2017 ; 70: 426-433.

https://jintensivecare.biomedcentral.com/articles/10.1186/2052-0492-1-15

Management information
Registered date
2012 Year 10 Month 15 Day
Last modified on
2018 Year 06 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010690

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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