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Intravenous N-acetylcysteine in pediatric patients with nonacetaminophen acute liver failure: a placebo-controlled clinical trial Squires RH; Dhawan A; Alonso E; Narkewicz MR; Shneider BL; Rodriguez-Baez N; Olio DD; Karpen S; Bucuvalas J; Lobritto S; Rand E; Rosenthal P; Horslen S; Ng V; Subbarao G; Kerkar N; Rudnick D; Lopez MJ; Schwarz K; Romero R; Elisofon S; Doo E; Robuck PR; Lawlor S; Belle SHHepatology 2013[Apr]; 57 (4): 1542-9N-acetylcysteine (NAC) was found to improve transplantation-free survival in only those adults with nonacetaminophen (non-APAP) acute liver failure (ALF) and grade 1-2 hepatic encephalopathy (HE). Because non-APAP ALF differs significantly between children and adults, the Pediatric Acute Liver Failure (PALF) Study Group evaluated NAC in non-APAP PALF. Children from birth through age 17 years with non-APAP ALF enrolled in the PALF registry were eligible to enter an adaptively allocated, doubly masked, placebo-controlled trial using a continuous intravenous infusion of NAC (150 mg/kg/day in 5% dextrose in water [D5W]) or placebo (D5W) for up to 7 days. The primary outcome was 1-year survival. Secondary outcomes included liver transplantation-free survival, liver transplantation (LTx), length of intensive care unit (ICU) and hospital stays, organ system failure, and maximum HE score. A total of 184 participants were enrolled in the trial with 92 in each arm. The 1-year survival did not differ significantly (P = 0.19) between the NAC (73%) and placebo (82%) treatment groups. The 1-year LTx-free survival was significantly lower (P = 0.03) in those who received NAC (35%) than those who received placebo (53%), particularly, but not significantly so, among those less than 2 years old with HE grade 0-1 (NAC 25%; placebo 60%; P = 0.0493). There were no significant differences between treatment arms for hospital or ICU length of stay, organ systems failing, or highest recorded grade of HE. CONCLUSION: NAC did not improve 1-year survival in non-APAP PALF. One-year LTx-free survival was significantly lower with NAC, particularly among those <2 years old. These results do not support broad use of NAC in non-APAP PALF and emphasizes the importance of conducting controlled pediatric drug trials, regardless of results in adults.|Acetylcysteine/*administration & dosage/*therapeutic use[MESH]|Adolescent[MESH]|Child[MESH]|Child, Preschool[MESH]|Double-Blind Method[MESH]|Female[MESH]|Free Radical Scavengers/administration & dosage/therapeutic use[MESH]|Hepatic Encephalopathy/drug therapy/mortality[MESH]|Humans[MESH]|Infant[MESH]|Infant, Newborn[MESH]|Infusions, Intravenous[MESH]|Liver Failure, Acute/*drug therapy/*mortality[MESH]|Liver Transplantation[MESH]|Male[MESH]|Severity of Illness Index[MESH]|Survival Rate[MESH]|Treatment Outcome[MESH] |
