UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Prospective observational study about factors which influence the blood concentration of propofol during continuous infusion
Title of the study (Brief title)	Study about the factors which influence the blood concentration of propofol during continuous infusion in ICU
Region	Japan

Condition
Condition	The patients under sedation in ICU by continuous infusion of propofol
Classification by specialty	Anesthesiology
Classification by malignancy	Others
Genomic information	YES

Objectives
Narrative objectives1	To reveal the relationship between the blood concentration of propofol and genetic UGT1A9 and CYP2B6 polymorphism , age, sex, blood pressure, liver function, kidney function, in patients under sedation in ICU.
Basic objectives2	Pharmacokinetics
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The relationship between the blood concentration of propofol and genetic polymorphism (UGT1A9,CYP2B6), age, sex, blood pressure, liver function, kidney function etc.
Key secondary outcomes

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1. Patients under sedation by continuous propofol infusion more than 24 hours at Kyushu University Hospital 2. Direct measurement of arterial pressure monitoring
Key exclusion criteria	1. Hemoglobin<7 g/dL 2. Patients who is not appropriate to this study
Target sample size	100

Research contact person
Name of lead principal investigator	Tatsuya Yoshihara
Organization	Faculty of Medical Science, Kyushu University
Division name	Department of Clinical Pharmacology
Address	3-1-1 Maidashi, Higashi-ku, Fukuoka
TEL	092-642-6082
Email	tatsuya@clipharm.med.kyushu-u.ac.jp

Public contact
Name of contact person	Tatsuya Yoshihara
Organization	Faculty of Medical Science, Kyushu University
Division name	Department of Clinical Pharmacology
Address	3-1-1 Maidashi, Higashi-ku, Fukuoka
TEL	092-642-6082
Homepage URL
Email	tatsuya@clipharm.med.kyushu-u.ac.jp

Sponsor
Institute	Department of Clinical Pharmacology, Faculty of Medical Science, Kyushu University
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	Self funding
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
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

Other administrative information
Date of disclosure of the study information	2014 Year 10 Month 07 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 10 Month 06 Day
Anticipated trial start date	2014 Year 10 Month 07 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	The blood sample is collected after propofol administration continues more than 24 hours, and the plasma concentrations of propofol are measured. Blood pressure, pulse rate, body temperature and blood test values before blood sampling are recorded. Genetic polymorphisms of CYP2B6 and UGT1A9 are analyzed.

Management information
Registered date	2014 Year 10 Month 07 Day
Last modified on	2016 Year 04 Month 07 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-bin/icdr_e/ctr_view.cgi?recptno=R000017866