Antimicrobial Treatment
Conditions
Keywords
Target Controlled Infusion, Pharmacokinetics, Cefepime, critically ill patients
Brief summary
For this study, a previously developed population pharmacokinetic (popPK) model for cefepime (Jonckheere et al., submitted to JAC) was programmed in Rugloop vII, which is a software program to drive an infusion pump. By entering patient data (such as gender, serum creatinine, age and weight) in Rugloop II, a patient-specific dose will be calculated and given to the patient. This concept is known as Target Controlled Infusion (TCI). The aim of this study is to prospectively validate the popPK model using TCI.
Interventions
OTHERTCI group
Drug: cefepime, Device: Target Controlled Infusion pump connected to Rugloop vII software
Sponsors
University Ghent
University Medical Center Groningen
Onze Lieve Vrouw Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male or female patients of 18 years of age or older, admitted to the hospital ICU and requiring administration of cefepime as part of their treatment * Patients within the weight range of 50 -120kg * Patients with calculated creatinine clearance within the range 15 to \> 90 ml/min, allocated to one of three groups as described above. * Written informed consent, or if not possible surrogate consent, or if not possible declaration for inclusion in an emergency, patient informed consent being signed as soon as possible. * Patient with an arterial catheter in place for other reason than the current study purpose
Exclusion criteria
* Patients displaying acute or chronic renal failure requiring renal replacement therapy * Pregnancy * Moribund patients * Known sensitivity or allergy to cefepime * Inclusion in another study involving antimicrobial treatment. * Patient participating in a research for which a period of exclusion is currently required by other study protocol, ethical committee or health authority. * Patient already previously included in the trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Median Absolute Preditive Error (MdAPE, %) of predicted versus measured cefepime plasma concentrations (mg/L) | During the first 5 days of cefepime therapy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of patients with Neurotoxicity related to cefepime based on Naranjo criteria | Evaluation during the first 5 days of cefepime therapy | — |
| Negativation of microbiological cultures | Evaluation during the first 5 days of cefepime therapy | When applicable, evaluation of semi-quantitative culture of clinical samples (e.g. respiratory samples). This is not mandatory for study inclusion. |
| Percentage of patients with clinical cure | At the end of the study (maximum 5 days after inclusion) | Clinical cure when all criteria are met: * Patient not deceased * WBC count between 4000/µL and 11000/µL OR decreased by 25% relative to peak value * CRP decrease of 50% relative to peak value * If respiratory infection: i) absence or decrease in sputa/tracheal secretions; ii) extubated and not re-intubated within 24h after cessation of cefepime (if relevant) * Body temperature between 35°C and 38°C |
Outcome results
None listed