The NACSTOP 2 trial: Investigation of the early cessation of N-acetylcysteine in patients following paracetamol overdose.
Monash Health
200 participants
Dec 1, 2019
Interventional
Conditions
Summary
Paracetamol is one of the most common medications taken in overdose around the world. It is readily available and does not require a prescription to purchase. N-acetylcysteine (NAC) is the antidote used to treat patients at risk of developing liver toxicity secondary to the metabolites of paracetamol that accumulate following paracetamol overdose. The standard NAC treatment regimen lasts 20 to 21 hours and requires admission to hospital. Patients who present to hospital and receive NAC for paracetamol overdose and have normal liver function and subsequently have a less than therapeutic paracetamol concentration and normal liver function with at least 12 hours of treatment with NAC are unlikely to go on to develop liver toxicity. All study participants will be required to stay in hospital for the usual 20 hours (the time for a standard NAC infusion as per the current treatment guidelines) and will have liver function tests measured at this time. This trial aims to determine that a shorter treatment regimen (12 hrs) for paracetamol overdose is safe.
Eligibility
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Interventions
N-acetylcysteine (NAC) given intravenously as 200mg/kg over 4 hours (infusion 1), then 100 mg/kg over 16 hour infusion rate (infusion 2) ie. at least half will be given e.g. 50mg/kg over 8 hours. Depending on 12 hour post initiation blood tests, infusion 2 may be ceased after at least 8 hours of infusion. ie . 12 hour protocol
Locations(6)
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ACTRN12619001549112