Physiologically-based Pharmacokinetic Modelling Applied to Acetaminophen- Poisoned Obese Children
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Poisoning
- Sponsor
- Hospices Civils de Lyon
- Enrollment
- 300
- Locations
- 1
- Primary Endpoint
- Acetaminophen concentration
- Last Updated
- 5 years ago
Overview
Brief Summary
Childhood obesity is increasing globally. Changes in body composition and physiology in obesity setting modify pharmacokinetic parameters and might increase the risk in case of poisoning. Acetaminophen is a drug often implied in poisoning in children population, especially in adolescent attempting suicide. In practice, clinicians use weight to assess intoxication severity, but depending on the weight chosen (actual weight, lean body weight, ideal weight,..) the severity assessment can change as well as medical care needed. In this context we hypothesize that a PBPK modelling would be helpful to predict toxic dosing in obese population and especially in obese adolescent or children. The primary objective of this study is to collect data related to acetaminophen-poisoned patient with at least one acetaminophen concentration sampling and whose clinical outcome is known in order to refine and validate such a PBPK model.
Investigators
Eligibility Criteria
Inclusion Criteria
- •All subjects \>/= 10 year old
- •Availability of at least one positive acetaminophen concentration with its associated sampling time
- •Known clinical outcome
Exclusion Criteria
- •\< 10 year old
- •lack of data-
Outcomes
Primary Outcomes
Acetaminophen concentration
Time Frame: 31 october 2021
With hour post-ingestion provided