UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009115 |
|---|---|
| Receipt number | 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 17:46:20 |
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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
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
masui@med.nagoya-cu.ac.jp
Sponsor or person
Institute
Nagoya City University Graduate School of Medical Sciences
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010690
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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