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

NCT04807634 | Unknown

• 1 other identifier: AinShamsU RCT
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Conditions

Coma

Keywords

Coma /antipsychotics/ lipid emulsion/acute toxicity

Outcome Measures

Primary Outcomes (1)

• Complete recovery

  Regaining consciousness with galasco coma scale 15/15 without presence of other clinical manifestations denoting antipsychotics toxicity.

  6 months

Study Arms (2)

Group A (control)

OTHER

Group A (control): that will receive the traditional supportive treatment for acute antipsychotic drugs overdose

Drug: Intravenous Lipid Emulsion (Intralipid 20%)

Group B (case)

OTHER

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%)

Interventions

Intravenous Lipid Emulsion (Intralipid 20%) DRUG

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.

Also known as: Intralipid 20%

Group A (control); Group B (case)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Hend salama shalby El Far

Cairo, Egypt

RECRUITING

Related Publications (5)

• Berling I, Buckley NA, Isbister GK. The antipsychotic story: changes in prescriptions and overdose without better safety. Br J Clin Pharmacol. 2016 Jul;82(1):249-54. doi: 10.1111/bcp.12927. Epub 2016 Apr 15.

  PMID: 26945707 BACKGROUND

• Divac N, Prostran M, Jakovcevski I, Cerovac N. Second-generation antipsychotics and extrapyramidal adverse effects. Biomed Res Int. 2014;2014:656370. doi: 10.1155/2014/656370. Epub 2014 Jun 3.

  PMID: 24995318 BACKGROUND

• Levine M, Ruha AM. Overdose of atypical antipsychotics: clinical presentation, mechanisms of toxicity and management. CNS Drugs. 2012 Jul 1;26(7):601-11. doi: 10.2165/11631640-000000000-00000.

  PMID: 22668123 BACKGROUND

• Muller SH, Diaz JH, Kaye AD. Clinical applications of intravenous lipid emulsion therapy. J Anesth. 2015 Dec;29(6):920-6. doi: 10.1007/s00540-015-2036-6. Epub 2015 Jun 7.

  PMID: 26049929 BACKGROUND

• Zyoud SH, Waring WS, Al-Jabi SW, Sweileh WM, Rahhal B, Awang R. Intravenous Lipid Emulsion as an Antidote for the Treatment of Acute Poisoning: A Bibliometric Analysis of Human and Animal Studies. Basic Clin Pharmacol Toxicol. 2016 Nov;119(5):512-519. doi: 10.1111/bcpt.12609. Epub 2016 May 20.

  PMID: 27098056 BACKGROUND

MeSH Terms

Conditions

Coma

Interventions

Fat Emulsions, Intravenous

Condition Hierarchy (Ancestors)

Unconsciousness; Consciousness Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Emulsions; Colloids; Dosage Forms; Pharmaceutical Preparations; Parenteral Nutrition Solutions; Pharmaceutical Solutions; Solutions; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Specialty Uses of Chemicals

Study Officials

• Manal A Abdel Salam, Professor

  Ain Shams University

  STUDY CHAIR

Central Study Contacts

Enas A El Taftazani, Professor

CONTACT

01223946023; enas.taft@gmail.com

Walaa G Abdel Hamid, Lecturer

CONTACT

01062261010; Walaagomaa@outlook.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized controlled trial (RCT).

Study Record Dates

• First Submitted: February 10, 2021
• First Posted: March 19, 2021
• Study Start: March 10, 2021
• Primary Completion: September 1, 2021
• Study Completion: September 1, 2021
• Last Updated: March 19, 2021

Record last verified: 2021-03

Locations

EG (1)