ACTRN12616001617459
Recruiting
Phase 4
A non-inferiority randomised controlled trial of a Shorter Acetylcysteine Regimen for Paracetamol Overdose – the SARPO trial.
Colin Page0 sites220 target enrollmentNovember 23, 2016
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Colin Page
- Enrollment
- 220
- Status
- Recruiting
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\.Single immediate release paracetamol overdoses of 30g or less with an initial paracetamol concentration above but less than twice the nomogram line (paracetamol ratio \<2\)
- •2\.Acetylcysteine can be safely commenced within 8 hours of ingestion.
- •3\.Informed consent can be obtained.
- •The paracetamol ratio is the first paracetamol concentration taken between four and 16 hours post ingestion divided by the paracetamol concentration on the 150mg/L at four\-hour standard nomogram line at the same time point.
Exclusion Criteria
- •1\. Staggered or repeated immediate release paracetamol overdoses.
- •2\. Single, staggered or repeated overdoses of sustained release paracetamol.
- •3\. Repeated supratherapeutic ingestion of paracetamol.
- •4\. Late presentation i.e. \>8 hours since ingestion timea.
- •5\. \>30g paracetamolb or paracetamol ratio \>2\.
Outcomes
Primary Outcomes
Not specified
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