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

Not Applicable

Recruiting

• Conditions: paracetamol overdose; Mental Health - Suicide; Oral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

• Registration Number: ACTRN12617000973314
• Lead Sponsor: Monash Health

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-07-06
• Last Update Posted: 21 July 2021

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 3000

Inclusion Criteria

All paracetamol overdose treated with acetylcysteine

Exclusion Criteria

No treatment with acetylcysteine or overdose of paracetamol.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary outcome will be the rate of acute liver injury (defined as peak Alanine transaminase (ALT)>150 IU/L and double baseline) stratified by time to first presentation bloods (<8 hrs or >8hrs). This will be assessed using serum samples.[During hospital admission.]

Secondary Outcome Measures

Name	Time	Method
Development of hepatotoxicity (alanine transaminase:ALT > 1000 IU/L). This will be assessed using serum samples.[During hospital admission]