PBPK Modelling Applied to Acetaminophen Poisoned Obese Children

Obesity Clinical Trial

— IntoxPara  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04850014
• Other study ID #: 69HCL20_1244
• Status: Recruiting
• Start date: January 1, 2021
• Est. completion date: October 2021

Study information

• Verified date: April 2021
• Source: Hospices Civils de Lyon
• Contact: Kim An NGUYEN, MD
• Phone: 4 72 31 94 11
• Email: kim-an.nguyen[@]chu-lyon.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: October 2021
• Est. primary completion date: May 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years and older

Eligibility

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-

Related Conditions & MeSH terms

• Obesity
• Poisoning

Intervention

Other:
• Anthropomorphism
Height, weight, body surface area, body mass index, exact age (date of birth or age in days, months and years), falling which year of birth gender
• Relevant clinical datas
Medical history Concomitant medication Paracetamol intake : dosage, delay, context, route of intake Alcohol intake Smoking status (including active and passive exposition or no exposition) Curative treatment / Antidote / purifying treatment received and time of introduction Clinical signs, Acetaminophen concentration in plasma with associated accurate time of sampling (date, hour and time following acetaminophen intake Liver and kindney function assessment by measure measuring plasma concentration of: AST, ALT, Factor V, Prothrombin, APTT, INR, albuminemia, bilirubin, phosphorus, pH, creatitine. And GFR estimation. Imaging.

Locations

Country	Name	City	State
France	Hospices Civils de Lyon	Lyon

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acetaminophen concentration	With hour post-ingestion provided	31 october 2021