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Correlation between Self-reported Paracetamol dose and Hepatotoxicity: A Retrospective Study at Phrapokklao Hospital

Correlation between Self-reported Paracetamol Dose and Hepatotoxicity: A Retrospective Study at Phrapokklao Hospital

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
TCTR
Registry ID
TCTR20251221001
Enrollment
350
Registered
2025-12-21
Start date
2019-12-01
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

Paracetamol overdose Paracetamol, APAP, Thailand

Interventions

AST or ALT greater than 1000 U/L, or total bilirubin greater than 2 mg/dL, or INR greater than 1.5,AST or ALT less than 1000 U/L, or total bilirubin less than 2 mg/dL, or INR less than 1.5
Diagnostic,Diagnostic
Hepatotoxicity,No hepatotoxicity

Sponsors

Phrapokklao Research Center
Lead Sponsor

Eligibility

Sex/Gender
All
Age
15 Years to 80 Years

Inclusion criteria

Inclusion criteria: Patients diagnosed with ICD-10 code T39.1 who received treatment at Phrapokklao Hospital, Chanthaburi, between January 2020 and July 2025, with paracetamol ingestion at hepatotoxic doses (greater than or equal to 7.5 grams or 150 mg/kg body weight) within 24 hours.

Exclusion criteria

Exclusion criteria: 1. Paracetamol dose below 7.5 grams or 150 mg/kg. 2. Unknown dose or unavailable laboratory data. 3. Repeated supratherapeutic ingestion over 24 hours. 4. Pre-existing severe liver disease or liver failure. 5. Body weight exceeding 100 kg.

Design outcomes

Primary

MeasureTime frame
Incidence of hepatotoxicity During hospitalization AST or ALT greater than 1000 U/L, or total bilirubin greater than 2 mg/dL, or INR greater than 1.5

Secondary

MeasureTime frame
risk factors associated with the development of hepatotoxicity During hospitalization 1. Patient age 2. Pre-existing liver disease 3. Time from ingestion to N-acetylcysteine (NAC) administration 4. Body weight

Countries

Thailand

Contacts

Public ContactTanunya Sakdadech

Phrapokklao Hospital

tsakdadech@gmail.com0846791427

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 10, 2026