Prediction of Detoxification Effect of Fat Emulsion Based on Drug Diffusion Law (NCT06926439) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Prediction of Detoxification Effect of Fat Emulsion Based on Drug Diffusion Law
China85 participantsStarted 2024-06-01
Plain-language 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.
Who can participate
Age range
18 Years – 85 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Maximum Plasma Concentration (Cmax) of the Overdosed Drug
Timeframe: From baseline (pre-emulsion infusion) up to 24 hours post-infusion
2
Time to Maximum Plasma Concentration (Tmax) of the Overdosed Drug
Timeframe: From baseline (pre-emulsion infusion) up to 24 hours post-infusion
3
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
4
Terminal Elimination Half-Life (t½) of the Overdosed Drug
Timeframe: From baseline (pre-emulsion infusion) up to 24 hours post-infusion
5
Plasma Clearance (CL) of the Overdosed Drug
Timeframe: From baseline (pre-emulsion infusion) up to 24 hours post-infusion
6
Elimination Rate Constant (Ke) of the Overdosed Drug
Timeframe: From baseline (pre-emulsion infusion) up to 24 hours post-infusion
Trial details
NCT IDNCT06926439
SponsorThe Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School