UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025933 |
|---|---|
| Receipt number | R000029816 |
| Scientific Title | Changes in blood concentration of antibiotics and development of pharmacokinetic model in cardiovascular surgery |
| Date of disclosure of the study information | 2017/01/31 |
| Last modified on | 2017/08/03 14:45:40 |
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Basic information
Public title
Changes in blood concentration of antibiotics and development of pharmacokinetic model in cardiovascular surgery
Acronym
Changes in blood concentration of antibiotics and development of pharmacokinetic model in cardiovascular surgery
Scientific Title
Changes in blood concentration of antibiotics and development of pharmacokinetic model in cardiovascular surgery
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Masato Nakasone |
Organization
Tottori University
Division name
Division of Anesthesiology and Critical Care Medicine
Zip code
Address
36-1, Nishi-cho, Yonago, Tottori, Japan
TEL
0859-38-6657
masui@med.tottori-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masato Nakasone |
Organization
Tottori University
Division name
Division of Anesthesiology and Critical Care Medicine
Zip code
Address
36-1, Nishi-cho, Yonago, Tottori, Japan
TEL
0859-38-6657
Homepage URL
masui@med.tottori-u.ac.jp
Sponsor or person
Institute
Division of Anesthesiology and Critical Care Medicine, Tottori University
Institute
Department
Personal name
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)
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
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 01 | Month | 31 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
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
Open public recruiting
Date of protocol fixation
| 2016 | Year | 12 | Month | 26 | Day |
Date of IRB
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
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029816
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
