UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007356 |
|---|---|
| Receipt number | R000008521 |
| Scientific Title | Development of patient individualization medication method of ampicillin/sulbactam and vancomycin when cardiovascular surgery |
| Date of disclosure of the study information | 2012/02/22 |
| Last modified on | 2015/08/24 20:00:28 |
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Basic information
Public title
Development of patient individualization medication method of ampicillin/sulbactam and vancomycin when cardiovascular surgery
Acronym
Medication method of ampicillin/sulbactam and vancomycin
Scientific Title
Development of patient individualization medication method of ampicillin/sulbactam and vancomycin when cardiovascular surgery
Scientific Title:Acronym
Medication method of ampicillin/sulbactam and vancomycin
Region
| Japan |
Condition
Condition
cardiovascular surgery condition
Classification by specialty
| Surgery in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aimed to use renal function to determine the most appropriate timing for intraoperative and postoperative repeated dosing of ampicillin-sulbactam, a commonly used prophylactic antibiotic, to maintain adequate concentrations throughout the course of surgery.
Basic objectives2
PK,PD
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Ampicillin (1 g)-sulbactam (0.5 g) was administered intravenously within 15 min of the cardiovascular surgery. Venous blood samples were drawn every 30 min after the administration. Then, on days 3- after initial administration venous dlood samples were drawn just before the next administration and after one hour i.v. infusion. Total concentrations of ampicillin and sulbactam in plasma were measured by high-performance liquid chromatography. Pharmacokinetic analyses of ampicillin and sulbactam were performed using the MULTI program. For each drug, total concentration-time data were fitted to a standard one-compartment model with zero-order input and first-order elimination. The pharmacokinetic parameters were volume of distribution (Vd, L) and total clearance (CL, L/h). Based on the means of the estimated Vd and CL values, the free concentration of ampicillin in plasma was predicted using the MULTI program, where the fraction of the plasma protein binding was assumed to be 20%. In the assessment of drug concentrations, values of 4 microg/mL were employed as a threshold (pharmacokinetic-pharmacodynamic target) for the free plasma concentrations of ampicillin, because the minimum inhibitory concentrations of ampicillin-sulbactam for 90% of the clinical isolates (MIC90) of methicillin-sensitive Staphylococcus aureus (MSSA) were estimated at 4 microg/mL in 2008 in Japan. This study aimed to determine the most appropriate timing for intraoperative dosing in order to maintain adequate concentrations throughout the operation. Also, we evaluate the pharmacokinetics of intravenously administered sulbactam to patients against acinetobacter baumannii infection.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Unasyn-s 1.5g or sulbacillin 1.5g was administered intravenously within 15 min of the cardiovascular surgery. Venous blood samples were drawn every 30 min after the administration. Then, on days 3- after administration, venous blood samples were drawn just before the next administration and after one i.v. infusion.
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
| 12 | years-old | < |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Adult patients who received ampicillin-sulbactam as antimicrobial prophylaxis during cardiovascular surgery
Key exclusion criteria
Neonate,infant,child,dialysis patient
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | MATSUMOTO KAZUAKI |
Organization
Graduate School of Medical and Dental Sciences Kagoshima University
Division name
Clinical Pharmacy and Pharmacology
Zip code
Address
8-35-1 Sakuragaoka, Kagoshima. Japan
TEL
099-275-5543
km1221@m.kufm.kagoshima-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | MATSUMOTO KAZUAKI |
Organization
Graduate School of Medical and Dental Sciences Kagoshima University
Division name
Clinical Pharmacy and Pharmacology
Zip code
Address
8-35-1 Sakuragaoka, Kagoshima. Japan
TEL
099-275-5543
Homepage URL
km1221@m.kufm.kagoshima-u.ac.jp
Sponsor or person
Institute
Kagoshima University hospital
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
鹿児島大学病院（鹿児島県）
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 02 | Month | 22 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
http://www.jiac-j.com/article/S1341-321X(12)70214-3/abstract
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
Completed
Date of protocol fixation
| 2009 | Year | 10 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 11 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2015 | Year | 08 | Month | 24 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 02 | Month | 22 | Day |
Last modified on
| 2015 | Year | 08 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008521
