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Comparing the Efficacy and Safety of the Standard 21-hour N-Acetylcysteine Regimen versus the Scottish and Newcastle Acetylcysteine Protocol (SNAP) 12-hour Regimen in Patients with Acute Paracetamol Toxicity. A randomizd controlled trial.

Comparing the Efficacy and Safety of the Standard 21-hour N-Acetylcysteine Regimen versus the Scottish and Newcastle Acetylcysteine Protocol (SNAP) 12-hour Regimen in Patients with Acute Paracetamol Toxicity. A randomizd controlled trial.

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
PACTR
Registry ID
PACTR202607643375797
Enrollment
142
Registered
2026-07-07
Start date
2025-11-01
Completion date
Unknown
Last updated
2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Injury, Occupational Diseases, Poisoning

Interventions

Nacetyl cysteine intravenous solution standard 21 hour NAC regimen
N acetyl cysteine intravenous solution 12 hour regimen

Sponsors

Self sponsor
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients aged 12 years or older (male and female) presenting with acute paracetamol toxicity requiring N-acetylcysteine treatment as per national guidelines (e.g., TOXBASE criteria). This includes patients admitted within 8 hours of a single acute paracetamol overdose, or presenting with a staggered overdose or uncertain time of ingestion requiring NAC.

Exclusion criteria

Exclusion criteria: patients aged less than 12 years old 2- known hypersensitivity or contraindication to N-acetylcysteine 3-individuals with pre-existing severe liver disease (e.g., cirrhosis, chronic liver failure) or other chronic comorbidities that may confound liver function assessment (e.g., chronic kidney disease, severe cardiovascular disease, diabetes, chronic pulmonary disease).

Design outcomes

Primary

MeasureTime frame
the study will be the incidence of hepatotoxicity, defined as an Alanine Aminotransferase (ALT) level greater than 1000 U/L within 48-72 hours of admission.

Secondary

MeasureTime frame
-The secondary outcomes will include the incidence and severity of adverse drug reactions (ADRs) to NAC (e.g., anaphylactoid reactions, nausea, vomiting), the duration of hospital stay, the need for intensive care unit (ICU) admission or intubation, the mortality rate, changes in liver function tests (ALT, AST, Bilirubin) and INR over time, the total dose of vasopressors required (if applicable), and arterial blood pressure and arterial blood gas parameters.

Countries

Egypt

Contacts

Public ContactHafsa salah

lecturer

hafsasalah66@gmail.com01123558563

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Sep 19, 2026