PBPK Modelling Applied to Acetaminophen Poisoned Obese Children
IntoxPara
Physiologically-based Pharmacokinetic Modelling Applied to Acetaminophen- Poisoned Obese Children
1 other identifier
observational
300
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2021
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2021
CompletedFirst Submitted
Initial submission to the registry
April 14, 2021
CompletedFirst Posted
Study publicly available on registry
April 20, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2021
CompletedApril 20, 2021
April 1, 2021
4 months
April 14, 2021
April 14, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Acetaminophen concentration
With hour post-ingestion provided
31 october 2021
Study Arms (2)
Poisoned patients
All subjects with paracetamolemia in the context of paracetamol poisoning
Control group
Acetaminophen-poisoned patient being non-obese
Interventions
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
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.
Eligibility Criteria
* Poisoned acetaminophen subjects * At least one acetaminophen blood sample result available in data base
You may qualify if:
- All subjects \>/= 10 year old
- Availability of at least one positive acetaminophen concentration with its associated sampling time
- Known clinical outcome
You may not qualify if:
- \< 10 year old
- lack of data-
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hospices Civils de Lyon
Lyon, 69000, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 14, 2021
First Posted
April 20, 2021
Study Start
January 1, 2021
Primary Completion
May 1, 2021
Study Completion
October 1, 2021
Last Updated
April 20, 2021
Record last verified: 2021-04