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Development of pharmacokinetic model for the target-concentration controlled infusion of cefazolin used as a prophylactic antibiotic in surgical patients

Status Approved

First Submitted Date

2021/02/26
Registered Date

2021/03/05
Last Updated Date

2021/02/26

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CRIS Required

WHO ICTRP (International Clinical Trial Registry Platform) Required

1. Background

Background - CRIS Registration Number, Unique Protocol ID, Public/Brief Title, Scientific Title, Acronym, MFDS Regulated Study, IND/IDE Protocol, Registered at Other Registry, Name of Registry/Registration Number
CRIS Registration Number	KCT0005963
Unique Protocol ID	2021-0304
Public/Brief Title	Development of pharmacokinetic model for the target-concentration controlled infusion of cefazolin used as a prophylactic antibiotic in surgical patients
Scientific Title	Development of pharmacokinetic model for the target-concentration controlled infusion of cefazolin used as a prophylactic antibiotic in surgical patients
Acronym	Cefazolin_PK
MFDS Regulated Study	No
IND/IDE Protocol	No
Registered at Other Registry	No
Healthcare Benefit Approval Status	Not applicable

2. Institutional Review Board / Ethics Committee

Institutional Review Board Information
Board Approval Status	Submitted approval
Board Approval Number	2021-0304
Approval Date	2021-02-26
Institutional Review Board Name	Asan Medical Center Institutional Review Board
Institutional Review Board Address	88, Olympic-ro 43-gil, Songpa-gu, Seoul
Institutional Review Board Telephone	02-3010-7166
Data Monitoring Committee	No

3. Contact Details

Contact Details Information - Contact Person for Principal Investigator / Scientific Queries, Contact Person for Public Queries, Contact Person for Updating Information의 Name, Title, Email, Telephone, Cellular Phone, Affiliation, Address
Contact Person for Principal Investigator / Scientific Queries
Name	Byungmoon Choi
Title	Associate Professor
Telephone	+82-2-3010-1704
Affiliation	Asan Medical Center
Address	88, Olympic-ro 43-gil, Songpa-gu, Seoul
Contact Person for Public Queries
Name	Kyung Mi Kim
Title	Dr.
Telephone	+82-2-3010-5631
Affiliation	Asan Medical Center
Address	88, Olympic-ro 43-gil, Songpa-gu, Seoul
Contact Person for Updating Information
Name	Kyung Mi Kim
Title	Dr.
Telephone	+82-2-3010-5631
Affiliation	Asan Medical Center
Address	88, Olympic-ro 43-gil, Songpa-gu, Seoul

4. Status

Status Information - Study Site, Overall Recruitment Status, Date of First Enrollment, Status of First Enrollment, Target Number of Participant, Primary Completion Date, Recruitment Status by Participating Study Site, Name of Study Site, Recruitment Status, Date of First Enrollment, Status of First Enrollemnt
Recruitment Status by Participating Study Site 1
Study Site	Single
Overall Recruitment Status	Not yet recruiting
Date of First Enrollment	2021-03-02 Anticipated
Target Number of Participant	40
Primary Completion Date	2021-12-31 , Anticipated
Study Completion Date	2021-12-31 , Anticipated
Name of Study	Asan Medical Center
Recruitment Status	Not yet recruiting
Date of First Enrollment	2021-03-02 ,

5. Source of Monetary / Material Support

Source of Monetary / Material Support Information - Organization Name, Organization Type, Project ID
1. Source of Monetary/Material Support
Organization Name	Korea Medical Device Development Fund
Organization Type	Government
Project ID	202011B25

6. Sponsor Organization

Sponsor Organization Information - Organization Name, Organization Type
1. Sponsor Organization
Organization Name	Asan Medical Center
Organization Type	Medical Institute

7. Study Summary

Study Summary Information
Lay Summary	<Purpose> The purpose of this study is to determine the population pharmacokinetic parameters required to apply target-controlled infusion of cefazolin, a prophylactic antibiotic that is administered by the bolus mode before surgical incision to surgical patients for preventing postoperative surgical site infection, using a nonlinear mixed effects model. <Problems with the current administration method> There are two problems of the conventional administration method of prophylactic antibiotics. First is the same dose in all adults. Secondly, the minimum inhibitory concentration (MIC) for inhibiting bacteria is known, but the administration method does not reflect this. <How to improve existing dosing method> Target concentration controlled infusion can be applied to the cefazolin to maintain the desired target concentration reflecting the individual's physical characteristics (ex: weight, renal function, etc.) <Need for study> Population pharmacokinetic parameters are required to apply the target concentration controlled infusion, but the appropriate pharmacokinetic parameters of cefazolin have not yet been determined.

Study Summary Information

Lay Summary

&lt;Purpose&gt; 
The purpose of this study is to determine the population pharmacokinetic parameters required to apply target-controlled infusion of cefazolin, a prophylactic antibiotic that is administered by the bolus mode before surgical incision to surgical patients for preventing postoperative surgical site infection, using a nonlinear mixed effects model. 

&lt;Problems with the current administration method&gt; 
There are two problems of the conventional administration method of prophylactic antibiotics. First is the same dose in all adults. Secondly, the minimum inhibitory concentration (MIC) for inhibiting bacteria is known, but the administration method does not reflect this. 

&lt;How to improve existing dosing method&gt; 
Target concentration controlled infusion can be applied to the cefazolin to maintain the desired target concentration reflecting the individual&#39;s physical characteristics (ex: weight, renal function, etc.) 

&lt;Need for study&gt; 
Population pharmacokinetic parameters are required to apply the target concentration controlled infusion, but the appropriate pharmacokinetic parameters of cefazolin have not yet been determined.

8. Study Design

Study Design Information - Study Type, Study Purpose, Phase, Intervention Model, Blinding/Masking, Blinded Subject, Allocation, Intervention Type, Intervention Description, Number of Arms, Arm Label, Target Number of Participant, Arm Type, Arm Description
Study Type	Interventional Study
Study Purpose	Prevention
Phase	Phase1
Intervention Model	Single Group
Blinding/Masking	Open
Allocation	Not Applicable
Intervention Type	Drug
Intervention Description	Cefazolin (2 g) as a prophylactic antibiotic is given before skin incision
Number of Arms	1
Arm 1	Arm Label Prophylactic antibiotics group
	Target Number of Participant 40
	Arm Type Experimental
	Arm Description Cefazolin (2g) as a prophylactic antibiotic is given before skin incision

9. Subject Eligibility

Subject Eligibility Information
Condition(s)/Problem(s)	* (S00-T98)Injury, poisoning and certain other consequences of external causes (T81.4)Infection following a procedure, NEC Patients scheduled for elective surgery undergoing general anesthesia
Rare Disease	No
Inclusion Criteria	Gender Both
	Age 20Year~80Year
	Description ● Patients over 20 to 80 years old ● Patients scheduled to undergo stomach or breast surgery at Asan Medical Center E rosette ● Patients with the physical status of the American Society of Anesthesiologists, Class 1-3 ● Patients who weigh 40 kg or more ● Patients scheduled to receive cefazolin as a prophylactic antibiotic ● Patients who have agreed in writing to voluntarily participate in this clinical study
Exclusion Criteria	● Pregnant or breastfeeding women ● Patients with a history of hypersensitivity to cefazolin ● Patients with a history of cefazolin given within 3 days of the scheduled operation time ● Patients with hemoglobin <8 g/dl ● Estimated glomerular filtration rate measured before surgery <60 ml/min ● Patients who received other clinical trial drugs within 7 days of the surgery ● Patients deemed inappropriate by investigators
Healthy Volunteers	No

10. Outcome Measure(s)

Outcome Measure(s) Information - Type of Primary Outcome, Primary Outcome, Outcome, Timepoint, Secondary Outcome, Outcome, Timepoint
Primary Outcome(s) 1
Type of Primary Outcome	Pharmacokinetics
Outcome	pharmacokinetic parameter (volume of distribution, clerance)
Timepoint	analysis using plasam concentrations of cefazolin obtained at 0, 2.5, 5, 10, 15, 45 minutes, 2, 6, and 8 hours after cefazolin administration
Secondary Outcome(s) 1
Outcome	adverse events
Timepoint	From administration of cefazolin until the last blood sample collection

11. Study Results and Publication

Study Results and Publication Information - Result Registered, Final Enrollment Number, Number of Publication, Publications, Results Upload, Date of Posting Results, Protocol URL or File Upload, Brief Summary
Result Registered	No

12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)

Sharing of Study Data Information - Sharing Statement, Time of Sharing, Way of Sharing
Sharing Statement	No

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