Evaluation of Differences Between the Standered NAC Regimen Protocol and the SNAP Regimen Protocol in the Treatment of Paracetamol Toxicity for Cases Presented Early and Late to Assiut University Hospitals in Terms of Safety and Efficiecy.

Comparative Study of Twelve Hours Versus Twenty One Hours Protocols of Intravenous N-Acetyl Cystiene Treatment in Paracetamol Toxicity at Assiut University Childern's Hospital

Evaluation of differences between the 21 h NAC regimen protocol and the 12 h NAC regimen protocol in the treatment of paracetamol toxicity (over dose) for cases presented early and late to Assiut University Hospitals in terms of safety and efficiecy.

Study Overview

• Status: Not yet recruiting
• Conditions: Paracetamol Toxicity
• Intervention / Treatment: Other: Evidence-based medical care for paracetamol toxicity; Other: Evidence-based medical care for paracetamol toxicity; Other: Evidence-based medical care for paracetamol toxicity; Other: Evidence-based medical care for paracetamol toxicity

Detailed Description

Acetamenphen is an analgesic and antipyretic drug . It is used as an active ingredient in many over-the-counter and prescription medications. It is generally considered safe at therapeutic doses. However, toxicity can be caused by multiple supratherapeutic doses or an acute, high overdose .

Acetaminophen is metabolized by the cytochrome P450 2E1 to N-acetyl para- benzoquinone-imine (NAPQI), a metabolit extremely toxic to the liver. This process depletes glutathione; thus, NAPQI binds to cellular and mitochondrial proteins to form adducts, impairing mitochondrial respiration and generating oxidative stress .

N-Acetylcysteine (NAC) is a 20-21-hour regimen which involves 3 weight related infusions. The first 150mg/kg is given over 1 hour, second 50mg/kg given over 4 hours and the last 100mg/kg given over 16 hours. This has been the optimal available therapy since 1980 .

Several evidence shows various adverse effect of this regimen which include anaphylactoid reaction, nausea, vomiting and medication error .

Recently the intravenous regimen has been simplified from a three-bag regimen to a two-bag regimen in many parts of the world, which has reduced the early very high concentrations and therefore adverse reaction rate .

Different clinical studies have been carried out to propose the adoption of a shorter regimen, the Scottish and Newcastle Antiemetic Pre-treatment (SNAP) 12-hours NAC regimen into clinical practice .

The SNAP is a two-bag regimen which involves giving 100mg/kg infusion over 2hours, then last 200mg/kg infusion giving over 10hours .

The SNAP regimen confirms that it produces fewer adverse drug reactions (ADRs) and has similar efficacy with regard to preventing liver injury when compared to the 21 h NAC regimen. Further clinical development and adoption of the SNAP regimen could improve treatment safety for this patient group, potentially shorten the length of treatment without compromising antidote effectiveness.

• Study Type: Interventional
• Enrollment (Estimated): 102
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: sabreen rabee hasan; Phone Number: 00201141586524; Email: Sabreenrabee1998@gmail.com
• Study Contact Backup: Name: marwa khalifa mohmad

Study Locations

• Egypt
  • Asyut, Egypt
    • Faculty of Medicine Assiut University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• All cases admitted to Assiut University Hospitals with history of acute paracetamol overdose ingestion .

Exclusion Criteria:

• * Co-ingestion of other hepatotoxic drugs .

  • Pre-existing liver diseases: Chronic hepatitis B or C, Autoimmune hepatitis, Wilson's disease, Known cirrhosis , Sepsis, shock, or hypoxic injury affecting the liver.
  • Hemolytic disorders causing abnormal LFTs.
  • Genetic or metabolic diseases that affect liver functions.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: patients early adminstared 21 h NAC protocol in treatment of paracetamol toxicity	Other: Evidence-based medical care for paracetamol toxicity; adminstration of Standered 21 h NAC regimen for patient comes early within 8 h from ingestion of toxic dose of paracetamol; Other: Evidence-based medical care for paracetamol toxicity; adminstration of Standered 21 h NAC regimen for patient comes late after 8 h from ingestion of toxic dose of paracetamol; Other: Evidence-based medical care for paracetamol toxicity; adminstration of 12 h NAC regimen for patient comes early within 8 h from ingestion of toxic dose of paracetamol; Other: Evidence-based medical care for paracetamol toxicity; adminstration of 12 h NAC regimen for patient comes late after 8 h from ingestion of toxic dose of paracetamol
Active Comparator: patients early adminstared 12 h NAC protocol in treatment of paracetamol toxicity	Other: Evidence-based medical care for paracetamol toxicity; adminstration of Standered 21 h NAC regimen for patient comes early within 8 h from ingestion of toxic dose of paracetamol; Other: Evidence-based medical care for paracetamol toxicity; adminstration of Standered 21 h NAC regimen for patient comes late after 8 h from ingestion of toxic dose of paracetamol; Other: Evidence-based medical care for paracetamol toxicity; adminstration of 12 h NAC regimen for patient comes early within 8 h from ingestion of toxic dose of paracetamol; Other: Evidence-based medical care for paracetamol toxicity; adminstration of 12 h NAC regimen for patient comes late after 8 h from ingestion of toxic dose of paracetamol
Active Comparator: patients late adminstared 21 h NAC protocol in treatment of paracetamol toxicity	Other: Evidence-based medical care for paracetamol toxicity; adminstration of Standered 21 h NAC regimen for patient comes early within 8 h from ingestion of toxic dose of paracetamol; Other: Evidence-based medical care for paracetamol toxicity; adminstration of Standered 21 h NAC regimen for patient comes late after 8 h from ingestion of toxic dose of paracetamol; Other: Evidence-based medical care for paracetamol toxicity; adminstration of 12 h NAC regimen for patient comes early within 8 h from ingestion of toxic dose of paracetamol; Other: Evidence-based medical care for paracetamol toxicity; adminstration of 12 h NAC regimen for patient comes late after 8 h from ingestion of toxic dose of paracetamol
Active Comparator: patients late adminstared 12 h NAC protocol in treatment of paracetamol toxicity	Other: Evidence-based medical care for paracetamol toxicity; adminstration of Standered 21 h NAC regimen for patient comes early within 8 h from ingestion of toxic dose of paracetamol; Other: Evidence-based medical care for paracetamol toxicity; adminstration of Standered 21 h NAC regimen for patient comes late after 8 h from ingestion of toxic dose of paracetamol; Other: Evidence-based medical care for paracetamol toxicity; adminstration of 12 h NAC regimen for patient comes early within 8 h from ingestion of toxic dose of paracetamol; Other: Evidence-based medical care for paracetamol toxicity; adminstration of 12 h NAC regimen for patient comes late after 8 h from ingestion of toxic dose of paracetamol

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
1-Change in serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST)	1-Mean change in ALT and AST levels (IU/L) from baseline to end of treatment	1- Day 2
change in serum creatinine level	Mean change in serum creatinine (mg/dL) from baseline to end of treatment.	Day 2
Incidence of adverse drug reactions	Number of participants who develop adverse drug reactions including nausea, vomiting, or anaphylactoid reactions during treatment	Day 2

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
rate of clinical recovery	Number of participants who achieve complete clinical recovery without complications	immediately after the intervention
incidence of serious complications	Number of participants who develop fulminant hepatic failure, hepatic encephalopathy, coma, or hemorrhage.	immediately after the intervention

Collaborators and Investigators

• Sponsor: Assiut University

Publications and helpful links

General Publications

• Morrison EE, Oatey K, Gallagher B, Grahamslaw J, O'Brien R, Black P, Oosthuyzen W, Lee RJ, Weir CJ, Henriksen D, Dear JW; POP Trial Investigators. Principal results of a randomised open label exploratory, safety and tolerability study with calmangafodipir in patients treated with a 12 h regimen of N-acetylcysteine for paracetamol overdose (POP trial). EBioMedicine. 2019 Aug;46:423-430. doi: 10.1016/j.ebiom.2019.07.013. Epub 2019 Jul 13.

Helpful Links

• Safety and Efficacy of the SNAP 12-hour Acetylcysteine Regimen for the Treatment of Paracetamol Overdose

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): June 1, 2027

Study Registration Dates

• First Submitted: February 20, 2026
• First Submitted That Met QC Criteria: March 2, 2026
• First Posted (Actual): March 6, 2026

Study Record Updates

• Last Update Posted (Actual): March 6, 2026
• Last Update Submitted That Met QC Criteria: March 2, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: N-acetylcysteine; paracetamol toxicity; acetaminophen poisoning; 12 h NAC protocol; 21 h NAC protocol
• Other Study ID Numbers: TTT of paracetamol toxicity

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No