UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Changes in blood concentration of antibiotics and development of pharmacokinetic model in cardiovascular surgery
Title of the study (Brief title)	Changes in blood concentration of antibiotics and development of pharmacokinetic model in cardiovascular surgery
Region	Japan

Condition
Condition	Heart disease, Thoracic large vessel disease
Classification by specialty	Anesthesiology Cardiovascular surgery Intensive care medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	In cardiovascular surgery, we examine whether blood concentration can be maintained by the current preventive antibiotic administration method. We will also examine whether pharmacokinetic models can be created in cardiovascular surgery.
Basic objectives2	PK,PD
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Changes in the blood concentration and the proportions exceeding the blood concentrations that are effective in mild / severe infections respectively in cefazolin (CEZ) and vancomycin (VCM)
Key secondary outcomes	1) Evaluation based on PK-PD theory on CEZ and VCM 2) Factors on blood levels of CEZ and VCM 3) development of optimal antibiotic administration model for cardiovascular surgery (CEZ, VCM) 4) Incidence of postoperative infection 5) In-hospital mortality rate, 28th day postoperative mortality rate, 90th postoperative mortality rate 6) Period of stay at ICU, artificial respiration management period 7) Postoperative complications (such as kidney injury)

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

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1) patients scheduled for cardiovascular surgery 2) patients who are able to obtain consent
Key exclusion criteria	1) patients who undergo cardiovascular surgery without both median sternotomy and intrathoracic operation 2) patients of emergency operation 3) patients with dementia or psychiatric disorders 4) female patients during pregnancy or possibly pregnancy 5) patients whom research investigator has determined to be inappropriate
Target sample size	50

Research contact person
Name of lead principal investigator	Masato Nakasone
Organization	Tottori University
Division name	Division of Anesthesiology and Critical Care Medicine
Address	36-1, Nishi-cho, Yonago, Tottori, Japan
TEL	0859-38-6657
Email	masui@med.tottori-u.ac.jp

Public contact
Name of contact person	Masato Nakasone
Organization	Tottori University
Division name	Division of Anesthesiology and Critical Care Medicine
Address	36-1, Nishi-cho, Yonago, Tottori, Japan
TEL	0859-38-6657
Homepage URL
Email	masui@med.tottori-u.ac.jp

Sponsor
Institute	Division of Anesthesiology and Critical Care Medicine, Tottori University
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
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	2017 Year 01 Month 31 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2016 Year 12 Month 26 Day
Anticipated trial start date	2017 Year 01 Month 31 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	In cardiovascular surgery, we examine whether blood concentration can be maintained by the current preventive antibiotic administration method. We will also examine whether pharmacokinetic models can be created in cardiovascular surgery.

Management information
Registered date	2017 Year 01 Month 31 Day
Last modified on	2017 Year 08 Month 03 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000029816