Evaluation of Intralipid efficacy for decreasing Amphotericin B-related nephrotoxicity in patients with fungal infections admitted in Amir-Alam and Imam Khomeini hospitals in Tehran during 1390-1391

Objectives: Evaluation of Intralipid efficacy for decreasing Amphotericin B-related nephrotoxicity is the main goal. Design: This is a single-blinded randomized clinical trial study. Setting and conduct: Participants in this study are randomized to intervention and control groups. Patients stay in hospital during study and necessary clinical evaluations and laboratory investigations are performed for them. Baseline renal function and its variations during treatment with Amphotericin B are continuously monitored. Finally, Amphotericin B-related nephrotoxicity that has been defined as 50% increase in baseline serum creatinine to a minimum of 2mg/dL in this study along with daily changes in serum creatinine level are compared between groups and differences are statistically analyzed. Participants: Patients with fungal infections admitted in Amir-Alam and Imam Khomeini hospitals in Tehran during 1390-1391 who need Amphotericin B for treatment are included. baseline serum creatinine over 2mg/dL and severe liver failure or cirrhosis are major exclusion criteria. A sample size of 30 was considered for this study. Interventions: In both groups, 1 mg/kg daily of Amphotericin B is mixed with dextrose 5% in a concentration of 0.1 mg/mL and infused over a 4-hour period. In intervention arm, the patients additionally receive 500 mL of Intralipid 10% daily that is started within 1 hour after infusion of Amphotericin B as soon as possible. Main outcome variable: serum creatinine level in mg/dL

Vice chancellor for research, Tehran University of Medical Sciences