Paracetamol RCT - Oral Vs Intravenous antidotes

Phase 3

Withdrawn

Conditions: iver cell injury in acetaminophen overdose.

Registration Number: SLCTR/2015/031

Lead Sponsor: South Asian Clinical Toxicology Research Collaboration (SACTRC)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Withdrawn

Sex: Not specified

Target Recruitment: Not specified

Inclusion Criteria

1. Age 16 years and above
2. All patients who have taken a paracetamol overdose (>200mg/kg) where the physician determines an antidote is to be administered

Exclusion Criteria

1. Patients presenting 24 hours or more after poisoning.
2. Patients who have already received an antidote (possible in other hospitals prior to transfer).
3. Patients who have received charcoal (which would interfere with oral antidotes).
4. Patients under the age of 16.
5. Patients who are institutionalized for any mental health condition.
6. Patients with known cognitive impairment (e.g. dementia).
7. Patients with unrelated life threatening illness (e.g. terminal cancer).
8. Patients who are pregnant.
9. Patients who have had a paracetamol overdose in the previous 4 weeks or have taken a significant dose of any other toxic substance in addition to paracetamol.
10. Patients who are on warfarin.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Proportion of patients with miRNA (micro (Micro Ribonucleic acid) evidence of progressive hepatotoxicity following treatment for paracetamol overdose. This will be defined as a ten-fold or greater rise in miR122 over 24 hours from initial tests. [miR122 (micro RNA miR122): On admission (t=0) otherwise t=-5(just before starting the treatment) if there is delay >2hrs to initiate the antidote, and at the 24 hours (end of the treatment).]<br>

Secondary Outcome Measures