Conditions: Acetaminophen Overdose
Keywords: Acetaminophen overdose; induced hepatotoxicity, liver injury
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 17
Healthy volunteers: no

Brief summary:
The primary purpose of this study is determine if a new formulation of Acetadote is at least as effective as the current formulation in the prevention and treatment of acetaminophen overdose related liver injury.

Detailed description:
The primary objective of this study is to demonstrate non-inferiority of efficacy determined by the proportion of subjects who develop hepatotoxicity when treated with a new formulation of Acetadote and the proposed new dosing regimen compared to the rate of hepatotoxicity with the current formulation of Acetadote and the current dosing regimen.

Arms:
arm 1: Acetadote EF \[Ethylenediaminetetraacetic Acid (EDTA) - Free\] arm 2: Acetadote \[Old formulation containing EDTA\]

Interventions: intervention 1: Acetadote EF (Ethylenediaminetetraacetic Acid (EDTA) - Free) intervention 2: Acetadote
Intervention descriptions: intervention 1: Acetadote EF (Ethylenediaminetetraacetic Acid (EDTA) - Free) {new formulation} 200 mg/kg in 1000 ml diluent over 4 hours; then 100 mg/kg in 1000 ml diluent over 16 hours intervention 2: Acetadote \[old formulation\] 150 mg/kg in 200 mL diluent over 60 minutes; then Acetadote 50 mg/kg in 500 mL diluent over 4 hours; then Acetadote 100 mg/kg in 1000 mL diluent over 16 hours.

Protocol document: