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Development of patient individualization medication method of ampicillin/sulbactam and vancomycin when cardiovascular surgery

Development of patient individualization medication method of ampicillin/sulbactam and vancomycin when cardiovascular surgery - Medication method of ampicillin/sulbactam and vancomycin

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000007356
Enrollment
50
Registered
2012-02-22
Start date
2009-11-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

cardiovascular surgery condition

Interventions

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- af

Sponsors

Kagoshima University hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Adult patients who received ampicillin-sulbactam as antimicrobial prophylaxis during cardiovascular surgery

Exclusion criteria

Exclusion criteria: Neonate,infant,child,dialysis patient

Design outcomes

Primary

MeasureTime frame
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.

Countries

Japan

Contacts

Public ContactMATSUMOTO KAZUAKI

Graduate School of Medical and Dental Sciences Kagoshima University Clinical Pharmacy and Pharmacology

km1221@m.kufm.kagoshima-u.ac.jp099-275-5543

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026