PoisoningNCT06926439
Prediction of Detoxification Effect of Fat Emulsion Based on Drug Diffusion Law
An observational study of Poisoning and Toxicokinetics, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Poisoning, Toxicokinetics, Lipid Emulsion
- What is being tested?
- Long chain lipid emulsion
- Type of treatment
- Injection or infusion
- How many people
- 85 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2024to 31 May 2027
- How long will I take part?
- 7 Days
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Emergency Department of Nanjing Drum Tower Hospital admits patients
Who may be able to join
- 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;
Who cannot join
- 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;
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Poisoning, Toxicokinetics, Lipid Emulsion
- Being tested
- Long chain lipid emulsion
- Medical subject headings
- Poisoning
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Long chain lipid emulsionDrug
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From baseline (pre-emulsion infusion) up to 24 hours post-infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2025
- Study start1 Jun 2024
- Primary completion31 May 2027 (estimated)
- Study completion31 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PoisoningStudies of the same condition, open and under way.
- More trials run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 85 participants (estimated)
- Target duration
- 7 Days
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hao Sun, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06926439
- Sponsor's protocol ID
- 2024-LCYJ-MS-06
- Other IDs
- 2024-LCYJ-MS-06
- Status last verified
- Apr 2025
- First submitted
- 23 Jan 2025
- Last updated
- 13 Apr 2025
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediction of Detoxification Effect of Fat Emulsion Based on Drug Diffusion Law: Clinical Observational Study
- ClinicalTrials.gov ID
- NCT06926439
- Acronym / sponsor ID
- 2024-LCYJ-MS-06
- Conditions
- Poisoning, Toxicokinetics, Lipid Emulsion
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 85 participants (estimated)
- Lead sponsor
- The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolUniversity, hospital or other
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- 31 May 2027 (estimated)
- First posted
- 13 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 7 Days
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Emergency Department of Nanjing Drum Tower Hospital admits patients
Key inclusion criteria (4 listed)
- 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;
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Long chain lipid emulsionFor 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. | Drug | – |
Primary outcome
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.
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.
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.
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.
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Poisoning and Toxicokinetics, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 13 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum Plasma Concentration (Cmax) of the Overdosed Drug (time frame: From baseline (pre-emulsion infusion) up to 24 hours post-infusion). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2025.