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

NCT06926439 | Active Not Recruiting

• 1 other identifier: 2024-LCYJ-MS-06
• Study Type: observational
• Target: 85
• Locations: 1 country
• Sites: 1

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.

Conditions

Poisoning; Toxicokinetics; Lipid Emulsion

Outcome Measures

Primary Outcomes (6)

• 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

Interventions

Long chain lipid emulsion DRUG

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.

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Emergency Department of Nanjing Drum Tower Hospital admits patients

You may qualify if:

• 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;

You may not qualify if:

• 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;

Sponsors & Collaborators

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

Study Sites (1)

Nanjing Drum Tower Hospital

Nanjing, Jiangsu, 210008, China

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

plasma

MeSH Terms

Conditions

Poisoning

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 7 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: January 23, 2025
• First Posted: April 13, 2025
• Study Start: June 1, 2024
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): May 31, 2027
• Last Updated: April 13, 2025

Record last verified: 2025-04

Locations

CN (1)