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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

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07454590
Enrollment
102
Registered
2026-03-06
Start date
2026-04-01
Completion date
2027-06-01
Last updated
2026-03-06

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

Conditions

Paracetamol Toxicity

Keywords

paracetamol toxicity, acetaminophen poisoning, N-acetylcysteine, 12 h NAC protocol, 21 h NAC protocol

Brief summary

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.

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.

Interventions

OTHEREvidence-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

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender
ALL
Age
No minimum to 18 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
1-Change in serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST)1- Day 21-Mean change in ALT and AST levels (IU/L) from baseline to end of treatment
change in serum creatinine levelDay 2Mean change in serum creatinine (mg/dL) from baseline to end of treatment.
Incidence of adverse drug reactionsDay 2Number of participants who develop adverse drug reactions including nausea, vomiting, or anaphylactoid reactions during treatment

Secondary

MeasureTime frameDescription
rate of clinical recoveryimmediately after the interventionNumber of participants who achieve complete clinical recovery without complications
incidence of serious complicationsimmediately after the interventionNumber of participants who develop fulminant hepatic failure, hepatic encephalopathy, coma, or hemorrhage.

Countries

Egypt

Contacts

CONTACTsabreen rabee hasan
Sabreenrabee1998@gmail.com00201141586524
CONTACTmarwa khalifa mohmad

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 7, 2026