Sepsis
Conditions
Keywords
Pharmacokinetics; pharmacodynamic; imipenem; sepsis
Brief summary
Explore Imipenem/Cilastatin two-step dosing compared to 2 hours infusion in patients with severe whether can obtain better results of the pharmacokinetic/pharmacodynamic, for clinical rational use of antimicrobial agents, and provide theoretical support for optimizing dosage regimen.
Detailed description
Compared with Imipenem/Cilastatin 2 hours continuous dosing method and two-step dosing method (0.5 hours before enter half dose, after 1.5 hours, the other half of the input dose) of blood drug concentration in the body than the minimal inhibitory concentrations (MIC) pathogens percent of dosing interval duration (100% fT \> MIC), blood drug concentration in the body more than 4 times the minimal inhibitory concentrations (MIC) pathogens percent of dosing interval duration (100% fT \> 4 MIC), blood drug concentration peak and the ratio of the minimal inhibitory concentrations (MIC) pathogens (Cmax/MIC), blood drug concentration (Tmax) used in the peak time, used to guide clinical patients with severe infection of Imipenem/Cilastatin usage.
Interventions
DRUGImipenem
Patients in group I received a dose of imipenem/cilastatin 1g each every 8 hours or 0.5g every 6 hours optimized two-step infusion therapy (rapid first-step infusion in 30 min and slow second-step infusion above 1.5 hours)
Sponsors
Merck Sharp & Dohme LLC
Southeast University, China
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* sepsis or severe sepsis or severe infections in the previous 48 hours * treatment with imipenem/cilastatin (recommended by hospital microbiologists) * expected duration of hospital stays in the ICU ≥ 72 h from recruitment * recruited patients agreed to participate in this trial, and had set up a signed informed consent
Exclusion criteria
* with an allergy to carbapenems or with an adverse drug reaction to imipenem * acute or chronic renal failure assessed by serum creatinine concentrations \> 280 μmol/L (or creatinine clearance \<20mL/min) or those requiring continuous renal replacement therapy * drug or alcohol abuse * Pregnant and lactant women * patients near to death
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Area under the plasma concentration versus time curve (AUC) | up to 9 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Plasma Concentration | up to 9 months | immediately prior to imipenem/cilastatin administration (time 0 min) and at 30 min, 1h, 2h, 4h, 6h and 8h after administration of the infusion |
Other
| Measure | Time frame | Description |
|---|---|---|
| PK/PD indices | up to 9 moths | Time\>MIC (∫T\>MIC) and 4×MIC (∫T\>4×MIC) |
Countries
China
Contacts
Primary ContactKang Xu, master
Outcome results
None listed