Acetylcysteïne Dosing in acute PARacetamol intoxication

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON22271

Enrollment

2000

Registered

2020-08-30

Start date

2020-10-01

Completion date

Unknown

Last updated

2024-02-28

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

Conditions

Acute paracetamol intoxication

Interventions

none, it is a retrospective observational study

Eligibility

Inclusion criteria

Inclusion criteria: Patients with a serum level of paracetamol that is above the LOQ (5 or 10 mg/L).

Exclusion criteria

Exclusion criteria: Patients that have opted out from data collection

Design outcomes

Primary

Measure	Time frame
Proportion of moderate (PCM4 = 100 - 150 mg/L), severe (PCM4 = 150-300 mg/L) or massive acute paracetamol intoxications (PCM4 > 300 mg/L).	—

Secondary

Measure	Time frame
- Which dosing regimens for acetylcysteine are used in the Netherlands (this will be done using a survey to Dutch hospital pharmacists and is not a part of this research protocol). - In moderate, severe or massive acute paracetamol intoxications: o Proportion of cases where treatment was prolonged after 24hrs o Proportion of cases with hepatotoxicity (peak ALT > 1000 U/L) o Proprotion of cases that have been liver transplanted o Proportion of fatal cases due to acute paracetamol intoxication o Proportion of cases with altered INR o Proportion of cases with adverse events to acetylcysteine that necessitate other treatment o Proportion of cases with manageable adverse event to acetylcysteine - Possible association between PCM4 and secondary outcome parameters (treatment duration, hepatoxicity, liver transplantation, fatalities, altered INR) - Possible association between acetylcysteine treatment regimen and adverse events (manageable and events that necessitate other treatment)	—

Measure

Time frame

- Which dosing regimens for acetylcysteine are used in the Netherlands (this will be done using a survey to Dutch hospital pharmacists and is not a part of this research protocol). - In moderate, severe or massive acute paracetamol intoxications: o Proportion of cases where treatment was prolonged after 24hrs o Proportion of cases with hepatotoxicity (peak ALT > 1000 U/L) o Proprotion of cases that have been liver transplanted o Proportion of fatal cases due to acute paracetamol intoxication o Proportion of cases with altered INR o Proportion of cases with adverse events to acetylcysteine that necessitate other treatment o Proportion of cases with manageable adverse event to acetylcysteine - Possible association between PCM4 and secondary outcome parameters (treatment duration, hepatoxicity, liver transplantation, fatalities, altered INR) - Possible association between acetylcysteine treatment regimen and adverse events (manageable and events that necessitate other treatment)

—

Contacts

Public ContactMarieke Sturkenboom

University Medical Center Groningen

m.g.g.sturkenboom@umcg.nl050-3614071

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)