Gastroenterology in critical care · Acute liver failure
Intravenous N-acetylcysteine in early stage non-acetaminophen acute liver failure
| Design | Multicentre randomised, placebo-controlled trial |
|---|---|
| Treatment | Intravenous N-acetylcysteine |
| Control | Placebo |
| Population | 173 patients with non-paracetamol acute liver failure across all coma grades — 114 grade I to II and 59 grade III to IV: 81 N-acetylcysteine and 92 placebo |
| Follow-up | 3 weeks and 1 year |
| Primary endpoint | Overall survival at 3 weeks |
| Result | Overall survival at 3 weeks was 70% with N-acetylcysteine and 66% with placebo (one-sided p=0.283). Transplant-free survival was 40% versus 27% (one-sided p=0.043); in coma grades I to II it was 52% versus 30% (p=0.010), but in grades III to IV it was 9% versus 22% (p=0.912). |
| Secondary endpoints | Transplant-free survival, transplantation rate, outcome by coma grade |
Intravenous NAC improves transplant-free survival in patients with early stage non-acetaminophen-related acute liver failure. Patients with advanced coma grades do not benefit from NAC and typically require emergency liver transplantation.
The trial authors, in the published abstract
Overall survival was flat and the transplant-free survival benefit carried the trial — a distinction that matters when transplantation is available. The coma-grade restriction is the practical selection rule.
Lee WM, Hynan LS, Rossaro L, et al. Intravenous N-acetylcysteine improves transplant-free survival in early stage non-acetaminophen acute liver failure. Gastroenterology 2009 Sep;137(3):856-64, 864.e1.