Role of Intravenous Lipid Emulsion in Improving Coma of Acute Antipsychotics Poisoning

March 17, 2021 updated by: Ain Shams University

Role of Intravenous Lipid Emulsion in Improving Coma of Acute Antipsychotics Poisoning: A Randomized Controlled Trial in PoisonControl Center of Ain Shams University Hospitals

Intravenous Lipid Emulsion in Improving Coma Of Antipsychotic drugs Acute Poisoning: A Randomized Controlled Trial in Poison Control Center of Ain Shams University Hospitals

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Intravenous lipid emulsions (ILEs) have been recently used in treatment of acute toxicity caused by lipophilic drugs including local anesthetics, antidepressants, anti-arrhythmics, beta blockers and calcium channel antagonists with few case reports concerning their use in treatment of acute antipsychotics overdose (Muller et al., 2015).

To the best of our knowledge, no randomized controlled trials (RCTs) have been performed to evaluate the antidotal effect of ILEs on the level of consciousness of acutely poisoned patients by antipsychotics and their routine metabolic profile tests.

Acute poisoning by antipsychotics could result in various life-threatening toxic effects mainly on cardiovascular and central nervous systems (CNS). Tachycardia, hypotension, and QT prolongation in electrocardiogram are the most common cardiovascular findings while sedation, extrapyramidal symptoms, agitation, and coma are the most common CNS findings following acute antipsychotic exposures (Divac et al., 2014).

As acute antipsychotic drugs overdose lack specific antidote, the primary goal in treatment is aggressive supportive therapy. In order to prevent CNS depression and respiratory failure, patients may need to be supported by mechanical ventilation. Hypotension is treated by intravenous fluids with use of direct-acting vasopressors (Orazel et al., 2019).

Several mechanisms for the antidotal properties of ILEs have been proposed including their ability to capture lipophilic drugs and extract them from vital organs such as the heart and brain thus reducing their toxicity, preferential distribution of lipophilic drugs into a circulating lipid phase, thereby reducing tissue drug concentrations. In addition, ILEs have direct inotropic effect due to improved fatty acid oxidative metabolism resulting in restoration of myocardial contractility (Zyoud et al., 2016 & Kehayova et al., 2019).

Sample size:

• Based on the calculated sample size by statistics committee (Community Medicine, Environmental, and Occupational Medicine Department - Faculty of Medicine, Ain shams University), a total of at least 30 patients with history of acute intoxication by antipsychotic drugs will be enrolled and randomly assigned into case (n=15) and control (n=15) groups.

Method of rondamization:

• Randomization will be achieved via a computer-generated random -sequence table.

On admission, the patient will receive the conventional management including history taking, clinical examination, investigations and treatment .

Examination will be repeated every six hours through the period of hospital stay of the patient.

All clinical data of the patient will be recorded in a special sheet that include the following data :

  1. Sociodemographic data:

    • Age.
    • Gender.
    • Residence

  2. Intoxication data:

    • Type of antipsychotic drug responsible for intoxication.
    • Amount of antipsychotic drug (if available).
    • Mode of poisoning, whether suicidal, accidental, criminal or therapeutic error.
    • Route of intake of the poison.
    • Time elapsed between the exposure and arrival to the PCC-ASU (delay time).
    • Preconsultation management.
    • Presence of comorbidities (as underlying medical or psychiatric diseases).
    • The current medications used by the patient including all drugs used in treatment of diseases.

  3. Clinical data (on admission and during hospital stay):

    • In both groups, detailed examination of the patients will be carried out on admission and routinely according to the severity of poisoning.
    • Assessment of the level of consciousness of all patients under the study will be carried out on admission and every six hours by using Glasgow coma scale (GCS) and Alert, Voice, Pain, Unresponsive (AVPU) scale till the patient discharge or mortality.

  4. Investigations:

    • Laboratory: all required laboratory investigations will be performed including arterial blood gas (ABG) analysis, and routine metabolic profile tests (e.g. glucose, sodium, potassium, urea and creatinine).
    • Other required investigations: Electrocardigraphy (ECG) will be done on admission and 12 h later, then every 24 h till the patient discharge or mortality.

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • All adult comatose patients admitted to the ICU of Poison Control Center of Ain Shams University Hospitals with positive history of antisychotic drugs overdose during the period starting from the beginning of March 2020 to the end of Septemper 2021

Exclusion Criteria:

  • Based on the possibility of heterogeneity in hemodynamic parameters, laboratory variables, GCS and/or AVPU Scale, the following patients will be excluded:

    • Patients less than 18 years and more than 65 years.
    • Pregnant and lactating females.
    • Co-ingestion of other agents.
    • Presence of medical diseases (e.g. renal, hepatic, cardiovascular diseases) and chronic pancreatitis.
    • History of head trauma.
    • Presence of conditions where ILE is contraindicated.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Group A (control)
Group A (control): that will receive the traditional supportive treatment for acute antipsychotic drugs overdose
Drug: Intravenous Lipid Emulsion (Intralipid 20%)
Lipid emulsion or fat emulsion refers to an emulsion of lipid for human intravenous use. It is often referred to by the brand name of the most commonly used version, Intralipid, which is an emulsion of soy bean oil, egg phospholipids and glycerin, and is available in 10%, 20% and 30% concentrations. The 30% concentration is not approved for direct intravenous infusion, but should be mixed with amino acids and dextrose as part of a total nutrient admixture.
Other Names:
  • Intralipid 20%
Other: Group B (case)
that will receive the traditional supportive treatment for acute antipsychotic drugs overdose plus administration of 1.5 ml/kg ILE (20%) as a bolus over 1-2 minutes, followed by a continuous rate infusion of 0.25 ml/kg/min for the next 30 to 60 minutes
Drug: Intravenous Lipid Emulsion (Intralipid 20%)
Lipid emulsion or fat emulsion refers to an emulsion of lipid for human intravenous use. It is often referred to by the brand name of the most commonly used version, Intralipid, which is an emulsion of soy bean oil, egg phospholipids and glycerin, and is available in 10%, 20% and 30% concentrations. The 30% concentration is not approved for direct intravenous infusion, but should be mixed with amino acids and dextrose as part of a total nutrient admixture.
Other Names:
  • Intralipid 20%

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complete recovery
Time Frame: 6 months
Regaining consciousness with galasco coma scale 15/15 without presence of other clinical manifestations denoting antipsychotics toxicity.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams University

Investigators

  • Study Chair: Manal A Abdel Salam, Professor, Ain Shams University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 10, 2021

Primary Completion (Anticipated)

September 1, 2021

Study Completion (Anticipated)

September 1, 2021

Study Registration Dates

First Submitted

February 10, 2021

First Submitted That Met QC Criteria

March 17, 2021

First Posted (Actual)

March 19, 2021

Study Record Updates

Last Update Posted (Actual)

March 19, 2021

Last Update Submitted That Met QC Criteria

March 17, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AinShamsU RCT

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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