RecruitingPhase 3ACTRN12619001549112

The NACSTOP 2 trial: Investigation of the early cessation of N-acetylcysteine in patients following paracetamol overdose.


Sponsor

Monash Health

Enrollment

200 participants

Start Date

Dec 1, 2019

Study Type

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

Sex: Both males and females

Plain Language Summary

Simplified for easier understanding

Paracetamol overdose is one of the most common presentations to emergency departments and is treated with a medication called N-acetylcysteine (NAC), which protects the liver from damage. The current standard treatment involves a continuous intravenous infusion over 20–21 hours, which typically means an overnight hospital stay. This is burdensome for patients and costly for the health system. Research suggests that many patients who took a paracetamol overdose — particularly those who arrive at hospital quickly and who have normal liver function after 12 hours of NAC — are very unlikely to develop any liver problems at all. The NACSTOP 2 trial is testing whether it is safe to stop NAC treatment after just 12 hours in these lower-risk patients, rather than continuing for the full 20–21 hours. All participants will remain in hospital for the standard 20-hour period so their liver function can be monitored. You may be eligible if you have taken a paracetamol overdose and have normal liver function tests and low paracetamol levels after 12 hours of NAC treatment. Patients with pre-existing liver disease, those who took modified-release paracetamol, those who took more than 10 grams over 24 hours, or those who used alcohol or sedating drugs alongside the paracetamol would not qualify.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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. Depe

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)

Austin Health - Austin Hospital - Heidelberg

NSW,VIC, Australia

Dandenong Hospital - Dandenong

NSW,VIC, Australia

Casey Hospital - Berwick

NSW,VIC, Australia

Monash Medical Centre - Clayton campus - Clayton

NSW,VIC, Australia

Westmead Hospital - Westmead

NSW,VIC, Australia

Blacktown Hospital - Blacktown

NSW,VIC, Australia

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ACTRN12619001549112


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