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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-LCYJ-MS-06 | Other Grant/Funding Number | Nanjing Drum Tower Hospital |
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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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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Emergency Department of Nanjing Drum Tower Hospital admits patients
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nanjing Drum Tower Hospital | Nanjing | Jiangsu | 210008 | China |
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| ID | Term |
|---|---|
| D011041 | Poisoning |
| ID | Term |
|---|---|
| D064419 | Chemically-Induced Disorders |
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plasma
| 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 |