A trial of normal versus higher dose acetylcysteine in patients with paracetamol overdose

Phase 2

Active, not recruiting

• Conditions: Paracetamol overdose; Injury, Occupational Diseases, Poisoning

• Registration Number: ISRCTN17516192
• Lead Sponsor: Accord (United Kingdom)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-11-21
• Last Update Posted: 2024-03-04
• Study Completion: 2026-06-30

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

1. Single acute paracetamol overdose presenting to hospital within 24h of overdose. All tablets ingested over a period of 2 h or less. Accidental or deliberate overdoses are eligible. Overdose of paracetamol alone or mixtures of tablets are eligible.
2. Overdose at risk of toxicity: blood paracetamol concentration over ‘200 line’ on nomogram.
3. Provision of informed consent.
4. Adult (16 years old or above).

Exclusion Criteria

1. Patients that do not have the capacity to consent.
2. Patients who are pregnant or breastfeeding.
3. Patients who have previously participated in the study.
4. Patients who, in the opinion of the responsible clinician/nurse, are unlikely to complete the full course of NAC e.g. expressing wish to self-discharge.
5. Patients detained under the Mental Health Act.
6. Patients already started on NAC treatment.
7. Known overdose of a modified/extended release preparation of paracetamol.
8.Patients with known viral hepatitis or HIV.

Study & Design

• Study Type: Interventional
• Study Design: Not specified