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Efficacy of a two bag N-acetylcysteine(NAC) regimen to treat paracetamol overdose (2NAC study).

Efficacy of a two bag N-acetylcysteine(NAC) regimen to treat paracetamol overdose (2NAC study)

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12617000973314
Acronym
2 NAC study
Enrollment
2600
Registered
2017-07-06
Start date
2014-02-01
Completion date
2022-06-01
Last updated
2021-07-21

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 overdose is the most common pharmaceutical poisoning in developed countries and its incidence is increasing in the developing world. Overdose can lead to liver failure, and in the worst circumstances, death. In overdose, the increased production of N-acetyl para-benzoquinoneimine (NAPQI) depletes hepatic glutathione stores and eventually causes hepatocyte injury. Acetylcysteine is administered as the antidote to prevent hepatotoxicity in overdose. The typical three-bag infusion-dosing regimen in Australia is 150 mg/kg over 1 hour, 50 mg/kg over 4 hours and 100 mg/kg over 16 hours. Despite the safety of this regimen, there remains a significant amount of adverse reactions to acetylcysteine and delays between infusions. To this effect, a recent study of over 200 patients who received a two-bag acetylcysteine regimen was recently undertaken. A 200mg/kg loading dose of NAC was infused over four hours with a further 100 mg/kg infused over 16-hours. The incidence and severity of adverse reactions was significantly reduced, compared to the three-bag regimen, from 10% to 4.3%. A similar two-bag regimen has been adopted by various hospitals around Australia. The efficacy of this new two-bag regimen has not been determined. We aim to compare the rate of acute liver injury using a two-bag acetylcysteine regimen and compare this to the three-bag regimen in the setting of paracetamol overdose.

Interventions

Acetylcysteine intravenously (200mg/kg over 4 hours followed immediately by 100mg/kg over 16 h0urs) For patients requiring treatment with antidote post paracetamol overdose.

Sponsors

Monash Health
Lead SponsorHospital

Eligibility

Sex/Gender
All
Healthy volunteers
No

Inclusion criteria

All paracetamol overdose treated with acetylcysteine

Exclusion criteria

No treatment with acetylcysteine or overdose of paracetamol.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026