RecruitingPhase 3ACTRN12619001548123

Double NAC trial: Investigation of increased N-acetylcysteine dosing in patients treated for paracetamol overdose.


Sponsor

Monash Health

Enrollment

230 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. Conversely, patients who present late (greater than 8 hours post ingestion) to hospital, or with abnormal liver function, high paracetamol concentration and require NAC treatment, are likely to require a prolonged course of treatment and might develop liver failure. We aim to increase the dose of NAC in this high risk group and examine whether this decreases degree of liver injury and hospital length of stay.


Eligibility

Sex: Both males and females

Plain Language Summary

Simplified for easier understanding

Paracetamol (acetaminophen) is one of the most common medications taken in overdose worldwide. When taken in large amounts, paracetamol breaks down into substances that can damage the liver — sometimes severely. The standard treatment is an intravenous infusion of a medication called N-acetylcysteine (NAC), which protects the liver and helps the body clear the harmful by-products. The current standard course of NAC lasts about 20–21 hours. However, some patients present to hospital very late after their overdose, or already have signs of liver damage. These 'high-risk' patients may not benefit enough from the standard NAC dose. This study is testing whether giving a higher dose of NAC to these higher-risk patients reduces liver injury and shortens the time they need to stay in hospital. You may be eligible for this study if you have been admitted to hospital following a paracetamol overdose and have either abnormal liver function tests on arrival, or a very high paracetamol level in your blood. Pregnant patients and those with pre-existing liver disease are excluded, as are lower-risk patients who have normal liver tests after overdose.

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 200mg/kg over 4 hours, followed by 200mg/kg over 16 hours

N-acetylcysteine (NAC) given intravenously 200mg/kg over 4 hours, followed by 200mg/kg over 16 hours


Locations(6)

Dandenong Hospital - Dandenong

NSW,VIC, Australia

Austin Health - Austin Hospital - Heidelberg

NSW,VIC, Australia

Casey Hospital - Berwick

NSW,VIC, Australia

Monash Medical Centre - Clayton campus - Clayton

NSW,VIC, Australia

Blacktown Hospital - Blacktown

NSW,VIC, Australia

Westmead Hospital - Westmead

NSW,VIC, Australia

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ACTRN12619001548123


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