Evaluating N-acetylcysteine efficacy in the prevention of amphotericin B-induced nephrotoxicity

Authors
Category Primary study
Registry of TrialsIranian Registry of Clinical Trials
Year 2011
INTERVENTION: Control group: placebo 600 mg orally twice daily Intervention 1: Intervention group: N‐acetylcysteine 600 mg orally twice daily. Intervention 2: Control group: placebo 600 mg orally twice daily. Intervention group: N‐acetylcysteine 600 mg orally twice daily Treatment ‐ Drugs CONDITION: B37? B38 ? Certain infectious and parasitic diseases Fungal infections. ; Certain infectious and parasitic diseases PRIMARY OUTCOME: Nephrotoxicity. Timepoint: At baseline then weekly. Method of measurement: renal function tests (BUN, Cr), serum electrolytes and biomarkers (cystatine C and KIM‐1). INCLUSION CRITERIA: INCLUSION CRITERIA: 1‐ Age between 18 to 65 years 2‐ Hemodynamica stability (Mean arterial pressure > 70 mmHg and Systolic blood pressure > 90 mmHg) 3‐ Receiving AmB for treatment of fungal infections Exclusion criteria 1‐ Documented history of acute kidney injury or chronic kidney disease 2‐ The status of kidney function at baseline is unknown 3‐ Receiving N‐acetylcysteine (oral or parenteral) recently (during the last 1 month) 4‐ Documented history of hypersensitivity/anaphylactic reactions to N‐acetylcysteine 5‐ Co‐administration of antioxidants (e.g. vitamin E, vitamin C)
Epistemonikos ID: 8ba7988f8261552a24802bb8d47bcdc1070445da
First added on: Aug 22, 2024