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

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12619001548123

Enrollment

Registered

2019-11-11

Start date

2019-12-01

Completion date

Unknown

Last updated

2022-03-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief 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.

Interventions

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

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Healthy volunteers

Inclusion criteria

Patients requiring NAC following single acute or staggered overdose with abnormal liver function tests on presentation (ALT>40 U/L), or paracetamol concentration more than double the nomogram treatment line, modified-release paracetamol paracetamol ingestions.

Exclusion criteria

Exclusion criteria will be patients who are pregnant, intoxicated or sedated patients with co-ingested alcohol or sedating drugs. Single acute overdose patients who are at low risk - normal ALT (<40 IU/L) and paracetamol concentrations less than double the nomogram treatment line will be excluded. Patients with an ALT >40 IU/L on admission and documented preexisting liver disease will be excluded.

Outcome results