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The NACSTOP trial: Investigation of the early cessation of N-acetylcysteine after paracetamol overdose.

Investigation of the early cessation of N-acetylcysteine versus standard care on liver injury after paracetamol overdose.

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12615000938505
Acronym
NACSTOP
Enrollment
100
Registered
2015-09-08
Start date
2016-02-01
Completion date
2018-02-28
Last updated
2020-01-13

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

Conditions

None listed

Brief summary

The primary purpose of the study is to investigate whether ceasing the use of antidote (NAC) in patients presenting early with paracetamol overdose in a low risk population is feasible and safe.

Interventions

All patients with normal ALT and AST (within lab reference range) and paracetamol<132 micro mol/L, will be allocated to either intervention or control treatment. 200mg/kg of NAC intravenously over 4 hours, then 50mg/kg NAC over 8 hours intravenously then change to 1 litre of intravenous Compound serum Lactate over 8 hours if study criteria met at 12 hours (alanine transaminase and AST less than the upper limit of the lab reference range, paracetamol <132 micro mol/L) in intervention group. Bloo

All patients with normal ALT and AST (within lab reference range) and paracetamol<132 micro mol/L, will be allocated to either intervention or control treatment. 200mg/kg of NAC intravenously over 4 hours, then 50mg/kg NAC over 8 hours intravenously then change to 1 litre of intravenous Compound serum Lactate over 8 hours if study criteria met at 12 hours (alanine transaminase and AST less than the upper limit of the lab reference range, paracetamol <132 micro mol/L) in intervention group. Bloods will then be repeated again at 20 hrs post initiation of NAC. A normal alanine transaminase indicates no sign of liver toxicity and low paracetamol concentration at less than therapeutic dose of paracetamol in the blood. Lab reference range for ALT, AST will vary from institution but the higher end of the range is 50 IU/L. Strategies to monitor medication adherence include observation in hospital of administration by medical and nursing staff, and computer logging of drug administration by nursing staff.

Sponsors

Monash Health
Lead SponsorGovernment body

Study design

Allocation
Non-randomised trial
Primary purpose
Treatment

Eligibility

Sex/Gender
All
Age
16 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Single or staggered paracetamol overdose

Exclusion criteria

Not mentally competant ALT or AST > lab reference range and/or paracetamol > 132 micromol/L at 12 hours post NAC initiation. Participants will be enrolled prior to the blood tests at 12hrs post NAC treatment.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026