The primary objective is an external validation of the beta-lactam target non-attainment (BATMAN) risk score, a four-routinely available prediction model in adult critically ill patients with a convenient scoring system in Dutch hospitals.
ID
Source
Brief title
Condition
- Hepatobiliary neoplasms malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The individual BATMAN risk score values are calculated for each patient. The
calibration of the risk score will be assessed with a calibration plot, where
the predicted outcome (x-axis) will be plotted against the observed outcome
(y-axis). The discrimination of the diagnostic risk score will be displayed in
the concordance index, which is identical to the area under the receiver
operating curve.
Secondary outcome
The secondary parameters are the classification measures such as the positive
predictive value, negative predictive value, misclassification, sensitivity and
specificity.
The positive predictive value describes the ability of the risk score to
identify subjects that will not achieve target attainment. The negative
predictive value describes the ability of the risk score to identify subjects
that will achieve target attainment. The sensitivity describes the correctly
identified subjects that will not achieve target attainment, the specificity
describes the correctly identified subjects that will achieve target attainment
and the misclassification describes the total number of incorrectly identified
patients that will or will not achieve target attainment.
Background summary
Intensive care unit (ICU) patients are a highly heterogenic group of patients
that undergo extensive physiological alterations that will have impact on
antibiotic pharmacokinetics, such as beta-lactam antibiotics. For the
beta-lactams, achievement of an adequate drug level is associated with a higher
likelihood of clinical success and a decrease in the potential for
antimicrobial resistance. In order to predict which ICU patients would benefit
from therapeutic drug monitoring of beta-lactam antibiotics, a diagnostic
multi-variable prediction model was developed using the data from the EXPAT and
DOLPHIN studies. Variables in the diagnostic multi-variable prediction model
were then used to develop a risk score. This risk score intents targeted use of
beta-lactam antibiotic therapeutic drug monitoring in patients who are expected
to not achieve target exposure.
Study objective
The primary objective is an external validation of the beta-lactam target
non-attainment (BATMAN) risk score, a four-routinely available prediction model
in adult critically ill patients with a convenient scoring system in Dutch
hospitals.
Study design
A prospective multicenter cohort study.
Study burden and risks
With the exception of blood sampling, there is no intervention in this study
that may affect patient treatment. Antibiotic dosing will occur as deemed by
the treating clinician and their local dosing practices.
's Gravendijkwal 230
Rotterdam 3000 CA
NL
's Gravendijkwal 230
Rotterdam 3000 CA
NL
Listed location countries
Age
Inclusion criteria
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
Exclusion criteria
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
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT05542771 |
| CCMO | NL81245.078.22 |