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
ID
Bron
Verkorte titel
Aandoening
Acute paracetamol intoxication
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Proportion of moderate (PCM4 = 100 - 150 mg/L), severe (PCM4 = 150-300 mg/L) or massive acute paracetamol intoxications (PCM4 > 300 mg/L).
Achtergrond van het onderzoek
• 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.
Doel van het onderzoek
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
Onderzoeksopzet
Data collection is expected to take 2 years if all Dutch hospitals might participate.
Onderzoeksproduct en/of interventie
none, it is a retrospective observational study
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
Patients with a serum level of paracetamol that is above the LOQ (5 or 10 mg/L).
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
Patients that have opted out from data collection
Opzet
Deelname
Voornemen beschikbaar stellen Individuele Patiënten Data (IPD)
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In overige registers
| Register | ID |
|---|---|
| NTR-new | NL8862 |
| Ander register | METC UMCG : METC 2020-374 (non-WMO declaration) |