External validation of the beta-lactam target non-attainment (BATMAN) risk score in adult ICU patients: a diagnostic multivariate predictive risk model
- Conditions
- critically ill patientsInfection10019815
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 148
All patients admitted to the adult general ICU wards and given standard of care
intravenous therapy of the target antibiotic are screened for eligibility. In
order to be eligible to participate in this study, a subject must meet all of
the following criteria:
• Written informed consent has been obtained from the patient or their legally
authorised representative
• Age >=18 years
• Treated with one of the following beta-lactam antibiotics at the ICU with
intermitted dosage.
o Amoxicillin
o Amoxicillin with clavulanic acid
o Cefotaxime
o Ceftazidime
o Cefuroxime
o Flucloxacillin
o Meropenem
o Piperacillin with tazobactam
• Eligible blood material within 36 hours after start of beta-lactam antibiotic
to determine target attainment (100%*T > MICECOFF).
• Suitable intravenous/intra-arterial access to facilitate sample collection
A potential subject who meets any of the following criteria will be excluded
from participation in this study:
• Written consent has not been obtained
• <18 years
• Pregnancy
• Beta-lactam antibiotic cessation before blood sample collection
• Receiving beta-lactam antibiotic only as prophylaxis
• No intravenous/intra-arterial access
• Patients with renal replacement therapy
• Patients with burn injury
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The individual BATMAN risk score values are calculated for each patient. The<br /><br>calibration of the risk score will be assessed with a calibration plot, where<br /><br>the predicted outcome (x-axis) will be plotted against the observed outcome<br /><br>(y-axis). The discrimination of the diagnostic risk score will be displayed in<br /><br>the concordance index, which is identical to the area under the receiver<br /><br>operating curve.</p><br>
- Secondary Outcome Measures
Name Time Method <p>The secondary parameters are the classification measures such as the positive<br /><br>predictive value, negative predictive value, misclassification, sensitivity and<br /><br>specificity.<br /><br><br /><br>The positive predictive value describes the ability of the risk score to<br /><br>identify subjects that will not achieve target attainment. The negative<br /><br>predictive value describes the ability of the risk score to identify subjects<br /><br>that will achieve target attainment. The sensitivity describes the correctly<br /><br>identified subjects that will not achieve target attainment, the specificity<br /><br>describes the correctly identified subjects that will achieve target attainment<br /><br>and the misclassification describes the total number of incorrectly identified<br /><br>patients that will or will not achieve target attainment.</p><br>