Double NAC trial: Investigation of increased N-acetylcysteine dosing in patients treated for paracetamol overdose.
Phase 3
Recruiting
- Conditions
- paracetamol overdoseInjuries and Accidents - Poisoning
- Registration Number
- ACTRN12619001548123
- Lead Sponsor
- Monash Health
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 230
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary outcomes will be the rate of hepatic injury” (defined to be alanine transaminase (ALT) doubling and peak ALT >100IU/L measured at 20 hrs after the commencement of NAC infusion) and need for further antidote. ALT is assessed by serum assay. This is a composite primary outcome[0 and 20 hours post initiation of NAC]
- Secondary Outcome Measures
Name Time Method These will include development of hepatotoxicity (defined as ALT >1000 IU/L). ALT measured by serum assay.[0,20 hours post initiation and every 12 hrs till ALT peaked and downtrending];Peak INR>2. Measured by blood test.[During hospital admission (up to 2 weeks)];Development of fulminant hepatic failure. Determined by bedside/clinical assessment.[During hospital admission (up to 2 weeks)];Mortality. Determined by Bedside assessment.[During hospital admission (anytime up to 4 weeks post admission)];Adverse reactions to N-acetylcysteine. These may include angioedema, rash, hypotension, vomiting, nausea, wheeze. Determined by clinical examination[Up to 20 hours post initiation of N-acetylcysteine.]