Pharmacokinetics in Patients Receiving Continuous Renal Replacement Therapy

Patients in the intensive care unit often develop acute kidney injury (AKI) and require continuous renal replacement therapy (CRRT), a procedure that differs significantly from outpatient dialysis. While the rate of acute kidney injury in the United States has doubled during the last 10 years, less than 20% of the drugs used have been studied with regard to appropriate dosing for patients in intensive care units (ICUs) receiving CRRT. As a result, clinicians and pharmacists often end up making best guesses in terms of dosages of life saving drugs in critically ill patients.

The growing number of cases of AKI, increasing use of CRRT, and reliance on a large number of potentially life-saving medications in these critically ill patients necessitate a better understanding of basic pharmacokinetics in this setting. Standardized pharmacokinetics guided drug dosing studies during the pre-approval development process are urgently needed for drugs likely to be used in critically ill patients, and similar studies should be conducted on currently approved drugs commonly used in these patients.

A workgroup that included FDA staff, evaluated medication dosing during CRRT and prioritized drugs or classes of drugs to help generate key data to improve treatment for these critically ill patients.