Comparison of Amphotericin B Induced Nephrotoxicity between 6 Hours vwesus 24 Hours Continuous Infusion: A Randomized Controlled Trial

ABSTRACT

Abstract Comparison of Amphotericin B Induced Nephrotoxicity between 6 Hours vwesus 24 Hours Continuous Infusion  A Randomized Controlled Trial On-umar            Banpamai                                   MD* Kumthorn          Malathum                                   MD*** Somnuek           Domrongkitchaiporn               MD*** Weerawat         Manosuthi                                   MD**** Sasivimol           Rattanasiri                                 MSc (Biostatistics)*****         *Division of Infectious Diseases, Department of Medicine, BMA Medical College and Vajira Hospital     **Division of Infectious Diseases, Department of Medicine, Ramathibodi  Hospital, Mahidol Unrversity    ***Division of Nephrology, Department of Medicine, Ramathibodi  Hospital, Mahidol Unrversity  **** Department of Medicine, Bamrasnaradura Institute *****Clinical Epidemiology Unit,  Ramathibodi  Hospital, Mahidol Unrversity   Objective:  To compare nephrotoxicity and infusion-related reactions between 6 hours versus 24 hours infusion of amphotericin B. Study design:  Prospective, randomized controlled study. Subjects:  Seventy-two patients who required amphotericin B therapy for various indications, between August 2004 and March 2005 at Department of Medicine, Ramathibodi Hospital and Bamrasnaradura Institute were randomly allocated to receive either 6 hours or 24 hours infusion of amphotericin B. Methods:  Thirty-five patients received continuous infusion of amphotericin B for a period of 6 hours as a control group and 37 patients for a period of 24 hours as a study group. Creatinine clearance, serum potassium (k+), serum magnesium ( Mg+ ), fractional excretion of potassium and magnesium were determined in all patients once a week. Infusion-related side effects of both regimens were also recorded throughout the study. Main outcome measures:  Creatinine clearance at 7 and 14 days after receiving amphotericin B, infusion-related side effects, fractional excretion of potassium and magnesium.  Results:  Creatinine clearance at day 7 and day 14 in study group were 83.922.9 and 81.822.5 ml/min. In control group, creatinine clearance at day 7 and day 14 were 62.7 25.3 and 51.718.9 ml/min. These levels in study group were higher than control group significantly (p-value  0.05). The incidence of renal impairment, defined as doubling of baseline serum creatinine, in study and control group were 2.7% and 45.7% that was different significantly (p-value   0.001). The incidences of infusion-related reactions other than thrombophlebitis were significantly lower in study group. Fractional excretion of statistically different between the two groups.  Conclusion:  The creatinine clearance, the incidence of renal impairment and infusion-related reactions in continuous 24-hour infusion of amphotericin B were lower than 6-hour infusion. Key word amphotericin B, creatinine clearance, fractional excretion  Vajira Med J 2006 ; 50 153 - 164