Acute and chronic paracetamol overdose in paediatric population: Protocol of a prospective study of cohort to evaluate clinic factor and biomarkers to predict development of hepatotoxicity

[摘要] Background:InSpain, 30% of cases of acute liver failure remaining undetermined. Paracetamol is the main drug causing acute liver failure in children of some countries like theUnited States,UK and other European countries. The key factors to assess in paracetamol toxicity, the ingested dose and the time from the poisoning, are difficult to assess in children where accidental PAP or medication errors are not rare. Metabolomics technology may be able to identify specific biomarkers of toxicity and adverse events in early stages. The development of paracetamol toxicity biomarkers could have important clinical implications for patients who can not apply the Rumack-Matthew nomogram. The identification of new biomarkers that are specific to paracetamol intoxication could be useful in the evaluation of children with acute liver failure of unknown etiology, and to predict liver damage before elevation of transaminases.  Methods and design:This is an observational prospective study of case control. The protocol was approved by the Clinical Research Ethics Committee of theLa PazUniversityHospital. It will recruit patients who will be attending in the emergency paediatric atLa PazUniversityHospital, atNiñoJesusUniversityHospital, and atGregorioMarañónUniversity hospital with suspected acute or chronic intake of paracetamol.  Likewise, two cohorts of control will be recruited. It is expected to recruit at least 36 cases and 144 controls. Peripheral blood, plasma, serum and urine samples will be collected, paracetamol serum concentrations, hepatic and renal function, coagulation and metabolomic analysis.  Discussion:It is important to determine the clinical factors and biomarkers that predict the development of hepatotoxicity in paediatric population following acute and chronic intake of paracetamol and develop a predictive model to assess the risk of hepatotoxicity in both type of intoxication by paracetamol suited to paediatric patients for use in clinical practice.

[学科分类] 辅助和替代医学