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NCT Number: NCT06926439

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Poisoning Chemically-Induced Disorders Lipid Emulsion Toxicokinetics

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Nanjing Drum Tower Hospital

Nanjing, Jiangsu, 210008, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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;

Treatment and study plan

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.

Primary outcomes

  1. Maximum Plasma Concentration (Cmax) of the Overdosed Drug

    Time frame: 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.

  2. Time to Maximum Plasma Concentration (Tmax) of the Overdosed Drug

    Time frame: 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.

  3. Area Under the Plasma Concentration-Time Curve From 0 to Last Measurable Concentration (AUC0-last)

    Time frame: 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.

  4. Terminal Elimination Half-Life (t½) of the Overdosed Drug

    Time frame: 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.

  5. Plasma Clearance (CL) of the Overdosed Drug

    Time frame: 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.

  6. Elimination Rate Constant (Ke) of the Overdosed Drug

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Apr 13, 2025
Registry last updated
Apr 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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