Clinical trial NCT06926439: Prediction of Detoxification Effect of Fat Emulsion Based on Drug Diffusion Law
Official title: Prediction of Detoxification Effect of Fat Emulsion Based on Drug Diffusion Law: Clinical Observational Study
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Poisoning
Toxicokinetics
Lipid Emulsion
Lead sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Sponsor class: OTHER
First posted: 2025-04-13
Enrollment: 85
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Emergency Department of Nanjing Drum Tower Hospital admits patients

Brief summary: The goal of this observational study is to establish a predictive model for the clinical use value of fat emulsion as an antidote based on the physical information of fat emulsion on drug diffusion process.

The main question it aims to answer is:

Observing the effect of fat emulsion on the pharmacokinetic changes of overdose drugs; Observe and evaluate the therapeutic effect of long-chain fat emulsion as an antidote; Participants will have their whole blood samples collected for toxicology testing.


Eligibility criteria: Inclusion Criteria:

* Patients with a clear history of acute drug exposure;
* The exposed drug is a lipid soluble drug (with a lipid water distribution coefficient logP\>0);
* Age: 18-85 years old;
* The patient or guardian agrees to participate in this project and signs an informed consent form;

Exclusion Criteria:

* Patients with shock and severe lipid metabolism disorders (such as hyperlipidemia);
* Patients with unclear exposure history;
* Drug exposure time \> 24 hours;
* Exposure to two or more drugs;
* Select patients with specific detoxifying agents;
* Merge patients with severe cardiovascular and cerebrovascular diseases;
* Patients with negative blood toxicity test results or overdose of non-fat-soluble drugs;
* Those who fail to provide complete general information and clinical data;

Primary outcomes:
measure: Maximum Plasma Concentration (Cmax) of the Overdosed Drug
timeFrame: From baseline (pre-emulsion infusion) up to 24 hours post-infusion
measure: Time to Maximum Plasma Concentration (Tmax) of the Overdosed Drug
timeFrame: From baseline (pre-emulsion infusion) up to 24 hours post-infusion
measure: Area Under the Plasma Concentration-Time Curve From 0 to Last Measurable Concentration (AUC0-last)
timeFrame: From baseline (pre-emulsion infusion) up to 24 hours post-infusion
measure: Terminal Elimination Half-Life (t½) of the Overdosed Drug
timeFrame: From baseline (pre-emulsion infusion) up to 24 hours post-infusion
measure: Plasma Clearance (CL) of the Overdosed Drug
timeFrame: From baseline (pre-emulsion infusion) up to 24 hours post-infusion
measure: Elimination Rate Constant (Ke) of the Overdosed Drug
timeFrame: From baseline (pre-emulsion infusion) up to 24 hours post-infusion
Secondary outcomes:
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Nanjing Drum Tower Hospital
state: Jiangsu
Study officials:
References: