CompletedPhase 2

Efficacy of SMOF Lipid in the Management of Acute Poisoning With Clozapine

Egypt40 participantsStarted 2022-01-01

Plain-language summary

The goal of the current study was to evaluate whether SMOF lipid administration could be used as an adjuvant therapy to treat acute, moderate-to-severe clozapine poisoning.

Who can participate

Age range

18 Years – 66 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: The patients were enrolled in the study in accordance with the following: Gender and age: adult symptomatic males and females. Patients were admitted within 12 hours of exposure to the poison. Patients received no prior treatment before admission. Patients with moderate-to-severe carbamazepine poisoning according to the Poisoning Severity Score (PSS) Patients classified as high-risk (HR) with anti-depressant overdose risk assessment (ADORA) criteria. Exclusion Criteria: Patients were excluded if they had any of the following conditions: pregnant and lactating women. Patients with major medical conditions (e.g. diabetes mellitus), cardiovascular disease, renal, or hepatic failure). Patients suffering from hyperlipidemia. Malignancy. Co-ingestion.

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

Improvement in Conscious Levels Measured by Glasgow Coma Scale (GCS)

Timeframe: participants were monitored within 24 hours from admission to the hospital

Assessment of Intubation Requirement Using APACHE

Timeframe: participants were assessed within 24 hours from admission to the hospital

Length of Intensive Care Unit (ICU) Stay

Timeframe: up to one month

length of hospital stay

Timeframe: up to one month

Trial details

NCT IDNCT06413589

SponsorAlexandria University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-02-01

View on ClinicalTrials.gov More Acute Poisoning trials

Who can participate

Age range

18 Years – 66 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.

What they're measuring

Improvement in Conscious Levels Measured by Glasgow Coma Scale (GCS)

Timeframe: participants were monitored within 24 hours from admission to the hospital

Assessment of Intubation Requirement Using APACHE

Timeframe: participants were assessed within 24 hours from admission to the hospital

Length of Intensive Care Unit (ICU) Stay

Timeframe: up to one month

length of hospital stay

Timeframe: up to one month