Administration of amphotericin B in lipid emulsion decreases nephrotoxicity : Results of a prospective, randomized, controlled study in critically ill patients

Objectives : To evaluate the differences in efficacy and in clinical and biochemical tolerance to amphotericin B administered in a lipid emulsion compared with amphotericin B administered in 5% dextrose in water in the treatment of Candida albicans infection in intensive care unit (ICU) patients. Design : Prospective, controlled, randomized study, conducted during a 2.5-yr period, comparing the two treatment protocols. Setting : General ICU of a university-affiliated municipal hospital. Patients : Sixty consecutive critically ill patients with confirmed or suspected Candida infection. Interventions : Patients received amphotericin B (1 mg/kg/24 hrs), administered randomly in 5% dextrose in water (group A), or in lipid emulsion (20% Intralipid®) (group B). Measurements and Main Results : Clinical tolerance (fever, chills, hemodynamics), hepatorenal tolerance, and biological tolerance (serum electrolytes and coagulation profile) were evaluated. Patients receiving amphotericin B in lipid emulsion experienced a lower frequency rate of drug-associated fever (61.4% vs. 5.8%, p < .003) rigors (54% vs. 8.5%, p <.004), hypotension (17% vs. 0%), and nephrotoxicity (increase of serum creatinine concentration, 66.7% vs. 20%, p <.0002). Significant (264,500 ± 71,460 to 163,570 ± 34,450 mm 3 , p <.01) thrombocytopenia, not associated with active bleeding, occurred in patients receiving amphotericin B lipid in emulsion but not in patients receiving the drug in dextrose. Conclusions : Treatment with amphotericin B in a lipid emulsion when given to critically ill patients with Candida sepsis seems to be safer and as effective as the conventional mode of administration.