UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The measurement of dexmedetomidine for sedation in intensive care patients
Title of the study (Brief title)	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	Yoshihito Fujita
Organization	Nagoya City University Graduate School of Medical Sciences
Division name	Department of Anesthesiology and Medical Crisis Management
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	Yoshihito Fujita
Organization	Nagoya City University Graduate School of Medical Sciences
Division name	Department of Anesthesiology and Medical Crisis Management
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2012 Year 10 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results	https://www.ekja.org/DOIx.php?id=10.4097/kjae.2017.70.4.426
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.
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/icdr_e/ctr_view.cgi?recptno=R000010690