Effectiveness of N-acetyl Cysteine, Acetyl L- Carnitine and Medicated Paraffin Oil in Aluminium Phosphide Poisoning

Comparative Effectiveness of N-acetyl Cysteine, Acetyl L- Carnitine and Medicated Paraffin Oil in Acute Aluminium Phosphide Poisoning: A Clinical Trial

Aluminium Phosphide is a pesticide used in developing countries to prevent rodents and pests from spoiling the harvested grains. it is presented as tablets which can be administered accidently to humans or for committing suicide. this pesticide is fatal even in small concentration as mortality rate can reach 75- 100% of cases. in this study researchers tried to add some supplements to the routine treatment to improve and decrease the fatality rate.

Study Overview

• Status: Unknown
• Conditions: the Study Focus to Improve the Standard of Care Used for Aluminuim Phosphide Poisoning and to Save Patients With the Minimal Organ Damage
• Intervention / Treatment: Drug: Sodium Bicarbonate Powder and ondansetron; Drug: N-acetyl cysteine; Dietary supplement: acetyl L-carnitine; Drug: medicated paraffin oil

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Phase 4

Contacts and Locations

Study Locations

• Egypt
  • Abbasya
    • Cairo, Abbasya, Egypt, 11311
      • Poison Control Center of Ain-Shams University hospitals

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• All adult patients with history of acute intoxication with AlP presented to the Poison Control Center of Ain-Shams University hospitals during the period of the study

Exclusion Criteria:

1. Patients less than 18
2. Patients presented with delay time exceeding 12 hours after acute intoxication.
3. Patients with history of cardiac, renal or hepatic diseases.
4. Patients who show hypersensitivity to NAC, ALCAR or paraffin oil.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: control group; this group will have the standard and routine therapy of treatment of acute Aluminium Phosphide poisoning immediately after admission according to PCCA guidelines	Drug: Sodium Bicarbonate Powder and ondansetron; standard of care for treatment of aluminuim phosphide is provided for patients poisoned with aluminuim phosphide
Active Comparator: N- acetyl cysteine grouo; N-acetyl cysteine will be given at dose of 300mg/kg/d IV in the first day then 150 mg/kg/d IV in addition to standard of care according to PCCA guidelines	Drug: Sodium Bicarbonate Powder and ondansetron; standard of care for treatment of aluminuim phosphide is provided for patients poisoned with aluminuim phosphide; Drug: N-acetyl cysteine; a drug which can have an off label use as an antidot for aluminium phosphide poisoning in addition to sodium bicarbonate and ondansetron as standard of care
Active Comparator: Acetyl L-carnitine group; Acetyl L-carnitine will be given at dose of 50 mg/kg IV once to be followed by additional doses of 15 mg/kg IV q4hr infused over 30 min. standard of care according to PCCA guidelines will also be provided	Drug: Sodium Bicarbonate Powder and ondansetron; standard of care for treatment of aluminuim phosphide is provided for patients poisoned with aluminuim phosphide; Dietary supplement: acetyl L-carnitine; Naturallu occuring amino acid derivative which can be taken as a dietary supplement involves in mitochondrial function and energy production and is suggested to have a role in lowering organ damage resulting from aluminium phosphide poisonong in addition to sodium bicarbonate and ondansetron as standard of care
Active Comparator: Medicated paraffin oil group; Gastric decontamination with sodium bicarbonate (NaHCO3; 44 mEq, orally) and medicated paraffin oil (200 mL) will be administered in addition to standard of care according to PCCA guidelines	Drug: Sodium Bicarbonate Powder and ondansetron; standard of care for treatment of aluminuim phosphide is provided for patients poisoned with aluminuim phosphide; Drug: medicated paraffin oil; refined mixture of liquid hydrocarbons which used as laxative and is suggested to reduce absorption of aluminium phosphide if taken within two hours of administration of the toxin in addition to sodium bicarbonate and ondansetron as standard of care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
mortality rate reduction	the primary end point is to lower the mortality rate for patients poisoned with aluminium phosphide pellets	1 year
organ damage reduction	another primary end point is to reduce organ damage and injury for survivors	1 year

Collaborators and Investigators

• Sponsor: Cairo University
• Collaborators: Ain Shams University hospitals

Study record dates

Study Major Dates

• Study Start (Anticipated): October 1, 2020
• Primary Completion (Anticipated): October 1, 2021
• Study Completion (Anticipated): December 1, 2021

Study Registration Dates

• First Submitted: August 9, 2020
• First Submitted That Met QC Criteria: August 9, 2020
• First Posted (Actual): August 12, 2020

Study Record Updates

• Last Update Posted (Actual): August 12, 2020
• Last Update Submitted That Met QC Criteria: August 9, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Keywords: N-acetyl cysteine; Acety L- carnitine; paraffin oil; aluminium phosphide
• Additional Relevant MeSH Terms: Chemically-Induced Disorders; Poisoning; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Antiviral Agents; Antiemetics; Gastrointestinal Agents; Protective Agents; Dermatologic Agents; Micronutrients; Antipsychotic Agents; Tranquilizing Agents; Psychotropic Drugs; Serotonin Agents; Serotonin Antagonists; Anti-Anxiety Agents; Respiratory System Agents; Vitamins; Antioxidants; Antidotes; Vitamin B Complex; Emollients; Antipruritics; Free Radical Scavengers; Nootropic Agents; Expectorants; Acetylcysteine; N-monoacetylcystine; Acetylcarnitine; Ondansetron; Mineral Oil
• Other Study ID Numbers: R 66/2019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: individual paticipant data is decided not to be shared for the privacy of the patients as patients in each group will be coded in numbers instead of their names

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