Lipid Emulsion, Poisoning, Toxicokinetics
Conditions
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.
Interventions
DRUGLong chain lipid emulsion
For patients presenting with fat soluble drug overdose, administer a weight-based infusion of long-chain lipid emulsion at 0.05 ml/kg/min for 1 hour, not to exceed a total of 250 mL.
Sponsors
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maximum Plasma Concentration (Cmax) of the Overdosed Drug | From baseline (pre-emulsion infusion) up to 24 hours post-infusion | The highest observed plasma concentration of the overdosed drug following administration of long-chain lipid emulsion. Blood samples will be collected at predefined intervals to quantify drug concentration and assess the impact of fat emulsion on peak levels. |
| Time to Maximum Plasma Concentration (Tmax) of the Overdosed Drug | From baseline (pre-emulsion infusion) up to 24 hours post-infusion | The time point at which the plasma concentration of the overdosed drug reaches its maximum level. This will help determine whether long-chain lipid emulsion alters the rate of drug absorption or distribution. |
| Area Under the Plasma Concentration-Time Curve From 0 to Last Measurable Concentration (AUC0-last) | From baseline (pre-emulsion infusion) up to 24 hours post-infusion | The area under the plasma concentration-time curve from time 0 to the last measurable concentration. This is used to evaluate the overall drug exposure and how it may be modified by the fat emulsion. |
| Terminal Elimination Half-Life (t½) of the Overdosed Drug | From baseline (pre-emulsion infusion) up to 24 hours post-infusion | The time required for the plasma concentration of the overdosed drug to decrease by half. This measure will be used to assess whether long-chain lipid emulsion accelerates drug clearance. |
| Plasma Clearance (CL) of the Overdosed Drug | From baseline (pre-emulsion infusion) up to 24 hours post-infusion | The volume of plasma completely cleared of the overdosed drug per unit time, assessing how fat emulsion influences the drug's elimination. |
| Elimination Rate Constant (Ke) of the Overdosed Drug | From baseline (pre-emulsion infusion) up to 24 hours post-infusion | The first-order elimination rate constant indicating the speed at which the drug is removed from the body, measured using plasma concentration data over time. |
Countries
China
Outcome results
None listed