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Clinical Trials/NCT04850014
NCT04850014
Unknown
Not Applicable

Physiologically-based Pharmacokinetic Modelling Applied to Acetaminophen- Poisoned Obese Children

Hospices Civils de Lyon1 site in 1 country300 target enrollmentJanuary 1, 2021

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.

Registry
clinicaltrials.gov
Start Date
January 1, 2021
End Date
October 2021
Last Updated
5 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

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

Study Sites (1)

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