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

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