Study: Pediatric ECMO and Cefepime (PEACE)
Study Type: Prospective Pharmacokinetic Study
Study Period: November 2013 – February 2016
Extracorporeal membrane oxygenation (ECMO) provides partial or complete support for patients with severe cardiopulmonary failure, and can be used as a bridge to recovery from mechanical support/organ replacement. The impact of ECMO on the pharmacokinetics (PK) of commonly used intensive care drugs should be fully understood to ensure optimal drug therapy, minimal toxicity and improve patient outcomes.
In critically ill patients not receiving ECMO, numerous PK studies have demonstrated highly significant changes to drug exposure through interactions between the patient, pathology and the drug. The ECMO system introduces additional variables, which are inherent to the circuit itself, as well as the systemic inflammation that results from use of an extracorporeal circuit. Sequestration of drugs in the circuit, increased volume of distribution and decreased clearance are the major PK changes associated with ECMO, although the extent of such changes remains poorly characterized. The amount of variability in drug disposition and pharmacokinetics that is introduced by different circuit components is largely unknown. Therefore, the objective of Pediatric ECMO and Cefepime Study, or PEACE, is to gain preliminary data on the impact of ECMO on the pharmacokinetics of cefepime administered as standard of care to infants.
We hypothesize that the volume of distribution of cefepime will be increased, and the clearance reduced in patients receiving ECMO. Also, there will be variability in cefepime PK across different circuit types.
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