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
1 other identifier
interventional
102
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Apr 2026
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 20, 2026
CompletedFirst Posted
Study publicly available on registry
March 6, 2026
CompletedStudy Start
First participant enrolled
April 1, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 1, 2027
March 6, 2026
February 1, 2026
1 year
February 20, 2026
March 2, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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 Outcomes (2)
rate of clinical recovery
immediately after the intervention
incidence of serious complications
immediately after the intervention
Study Arms (4)
patients early adminstared 21 h NAC protocol in treatment of paracetamol toxicity
ACTIVE COMPARATORpatients early adminstared 12 h NAC protocol in treatment of paracetamol toxicity
ACTIVE COMPARATORpatients late adminstared 21 h NAC protocol in treatment of paracetamol toxicity
ACTIVE COMPARATORpatients late adminstared 12 h NAC protocol in treatment of paracetamol toxicity
ACTIVE COMPARATORInterventions
adminstration of Standered 21 h NAC regimen for patient comes early within 8 h from ingestion of toxic dose of paracetamol
Eligibility Criteria
You may qualify if:
- All cases admitted to Assiut University Hospitals with history of acute paracetamol overdose ingestion .
You may not qualify if:
- \* 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Faculty of Medicine Assiut University
Asyut, Egypt
Related Publications (1)
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.
PMID: 31311721BACKGROUND
Related Links
Central Study Contacts
marwa khalifa mohmad
CONTACT
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- demonstrator of clinical toxicology
Study Record Dates
First Submitted
February 20, 2026
First Posted
March 6, 2026
Study Start
April 1, 2026
Primary Completion (Estimated)
April 1, 2027
Study Completion (Estimated)
June 1, 2027
Last Updated
March 6, 2026
Record last verified: 2026-02