Prediction of Detoxification Effect of Fat Emulsion Based on Drug Diffusion Law

Prediction of Detoxification Effect of Fat Emulsion Based on Drug Diffusion Law: Clinical Observational Study

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Poisoning; Toxicokinetics; Lipid Emulsion
• Intervention / Treatment: Drug: Long chain lipid emulsion

• Study Type: Observational
• Enrollment (Estimated): 85

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210008
      • Nanjing Drum Tower Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Emergency Department of Nanjing Drum Tower Hospital admits patients

Description

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;

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximum Plasma Concentration (Cmax) of the Overdosed Drug	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.	From baseline (pre-emulsion infusion) up to 24 hours post-infusion
Time to Maximum Plasma Concentration (Tmax) of the Overdosed Drug	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.	From baseline (pre-emulsion infusion) up to 24 hours post-infusion
Area Under the Plasma Concentration-Time Curve From 0 to Last Measurable Concentration (AUC0-last)	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.	From baseline (pre-emulsion infusion) up to 24 hours post-infusion
Terminal Elimination Half-Life (t½) of the Overdosed Drug	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.	From baseline (pre-emulsion infusion) up to 24 hours post-infusion
Plasma Clearance (CL) of the Overdosed Drug	The volume of plasma completely cleared of the overdosed drug per unit time, assessing how fat emulsion influences the drug's elimination.	From baseline (pre-emulsion infusion) up to 24 hours post-infusion
Elimination Rate Constant (Ke) of the Overdosed Drug	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.	From baseline (pre-emulsion infusion) up to 24 hours post-infusion

Collaborators and Investigators

• Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2024
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): May 31, 2027

Study Registration Dates

• First Submitted: January 23, 2025
• First Submitted That Met QC Criteria: April 7, 2025
• First Posted (Actual): April 13, 2025

Study Record Updates

• Last Update Posted (Actual): April 13, 2025
• Last Update Submitted That Met QC Criteria: April 7, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Chemically-Induced Disorders; Poisoning
• Other Study ID Numbers: 2024-LCYJ-MS-06 (Other Grant/Funding Number: Nanjing Drum Tower Hospital)