ESETT Pharmacokinetic-Pharmacodynamic (PK)

The specific aim of the PK/PD element of the study is to relate drug exposure (pAUC from time 0]60 min after start of drug infusion) with seizure cessation, the ESETT primary outcome, and key secondary outcomes. As part of this aim, we will use a sparse sampling approach for pharmacokinetic assessment to minimize the blood draws during this emergent condition. Established pharmacokinetic models combined with individual concentration]time data will then be used to derive each subjectfs pAUC. The pAUC values and clinical outcomes will be used to evaluate exposure]response relationships. The effect of variables such as age (children, adults, and elderly), sex, weight/BMI, and seizure etiology on these exposure]response relationships will be investigated. The results of our study will inform clinical dosing of these drugs in ESE as well as future clinical studies of this condition.