Burn Patients
Conditions
Keywords
Burns, Ertapenem, Pharmacokinetics
Brief summary
This study will examine the pharmacokinetics of ertapenem in ventilated badly (\> 30% SCT) burn patients.
Interventions
DRUGErtapenem
The patient received two injections of ertapenem, at a dose of 1g.j-1 by intravenous injection of 30 minutes, separated by 24 h.
Sponsors
Nantes University Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Patients aged 18 to 70 years * Burned on 30 to 60% of their body surface * Mechanical ventilation * Hospitalized in the intensive care unit of Nantes University Hospital for less than 8 days. * Which the family gave consent * insured
Exclusion criteria
* Patients whose family refused to sign the consent for participation. * Patients allergic to beta lactam * Patients with renal failure with creatinine clearance \<80 ml.mn-1 * Pregnant women * Persons protected by the law
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Measurement of serum concentrations of total ertapenem from the second injection in order to calculate Cmax, Vz, ClP , ClR , ClNR , fe, T1/2b et AUC0 - alpha. | Blood samples 5 min after the end of the second injection and 1 h, 2 h, 4 h, 6 h, 8 h, 12 h, 24 h after the start of the second injection | Current study the pharmacokinetics (Cmax, Vz, ClP , ClR , ClNR , fe, T1/2beta, AUC 0 - alpha) in a population of burn patients. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time between injection and observation of a serum concentration less than the critical concentration below | Blood samples 5 min after the end of the second injection and 1 h, 2 h, 4 h, 6 h, 8 h, 12 h, 24 h after the start of the second injection | Check that the injection of 1 g ertapenem achieves a serum concentration above the critical concentration of bacteria usually isolated in cases of early infection for more than 40% of the time between two injections (t / MIC\> 40 %), this ratio being one of the criteria predictive of efficacy of beta-lactam antibiotics. |
| Time needed between injections in order to obtain a concentration greater than the critical concentration below for the duration of time between two injections | Blood samples 5 min after the end of the second injection and 1 h, 2 h, 4 h, 6 h, 8 h, 12 h, 24 h after the start of the second injection | Study when two injections of ertapenem serum concentrations fall below the critical concentrations of bacteria usually isolated in cases of early infection, if they become. |
Countries
France
Contacts
STUDY_CHAIRRonan LE FLOCH, PH
Nantes University Hospital
Outcome results
None listed