No registrations found.
ID
Source
Brief title
Health condition
Acute paracetamol intoxication
Sponsors and support
Intervention
Outcome measures
Primary outcome
Proportion of moderate (PCM4 = 100 - 150 mg/L), severe (PCM4 = 150-300 mg/L) or massive acute paracetamol intoxications (PCM4 > 300 mg/L).
Secondary outcome
- 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)
Background summary
• Background
The antidote in paracetamol overdose is acetylcysteine. Different regimens for dosing of acetylcysteine exist. The most effective dose is unknown.
• Main research question
We want to investigate which acetylcysteine dosing regimens are applied in the Netherlands. We want to investigate what proportion of Dutch acute paracetamol intoxications is moderate (paracetamol level at 4 hrs after ingestion (PCM4) = 100-150 mg/L), severe (PCM4 = 150-300 mg/L) or massive (PCM4 > 300 mg/L). Of these moderate, severe and massive paracetamol intoxications, in what proportion of intoxications is treatment prolonged after 24 hrs, adverse events of acetylcysteine have occurred, hepatotoxicity (peak ALT > 1000 U/L) has occured, liver transplantation has taken place or death has occurred.
• Design (including population, confounders/outcomes)
Observational retrospective study
• Expected results
We expect to gain insight into effective (non toxic) acetylcysteine dosing in acute paracetamol intoxication.
Study objective
We think that not every patient with a paracetamol intoxication might need the high dose of acetylcysteïne antidote we are used to dose in the Netherlands
Study design
Data collection is expected to take 2 years if all Dutch hospitals might participate.
Intervention
none, it is a retrospective observational study
Inclusion criteria
Patients with a serum level of paracetamol that is above the LOQ (5 or 10 mg/L).
Exclusion criteria
Patients that have opted out from data collection
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL8862 |
| Other | METC UMCG : METC 2020-374 (non-WMO declaration) |