Ignite Creation Date:
2025-12-25 @ 2:24 AM
Ignite Modification Date:
2025-12-27 @ 7:55 AM
Study NCT ID:
NCT04807634
Status:
UNKNOWN
Last Update Posted:
2021-03-19
First Post:
2021-02-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Role of Intravenous Lipid Emulsion in Improving Coma of Acute Antipsychotics Poisoning
Sponsor:
Ain Shams University
Organization:
Study Overview
Official Title:
Role of Intravenous Lipid Emulsion in Improving Coma of Acute Antipsychotics Poisoning: A Randomized Controlled Trial in PoisonControl Center of Ain Shams University Hospitals
Status:
UNKNOWN
Status Verified Date:
2021-03
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Intravenous Lipid Emulsion in Improving Coma Of Antipsychotic drugs Acute Poisoning: A Randomized Controlled Trial in Poison Control Center of Ain Shams University Hospitals
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.
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: