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

NCT04509258 | Unknown Phase 4 DMC

• 1 other identifier: R 66/2019
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

the Study Focus to Improve the Standard of Care Used for Aluminuim Phosphide Poisoning and to Save Patients With the Minimal Organ Damage

Keywords

N-acetyl cysteine; Acety L- carnitine; paraffin oil; aluminium phosphide

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (4)

control group

PLACEBO COMPARATOR

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

N- acetyl cysteine grouo

ACTIVE COMPARATOR

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: N-acetyl cysteine; Drug: Sodium Bicarbonate Powder and ondansetron

Acetyl L-carnitine group

ACTIVE COMPARATOR

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

Dietary Supplement: acetyl L-carnitine; Drug: Sodium Bicarbonate Powder and ondansetron

Medicated paraffin oil group

ACTIVE COMPARATOR

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: medicated paraffin oil; Drug: Sodium Bicarbonate Powder and ondansetron

Interventions

N-acetyl cysteine DRUG

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

N- acetyl cysteine grouo

acetyl L-carnitine DIETARY_SUPPLEMENT

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

Acetyl L-carnitine group

medicated paraffin oil DRUG

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

Medicated paraffin oil group

Sodium Bicarbonate Powder and ondansetron DRUG

standard of care for treatment of aluminuim phosphide is provided for patients poisoned with aluminuim phosphide

Acetyl L-carnitine group; Medicated paraffin oil group; N- acetyl cysteine grouo; control group

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Cairo University: lead
• Ain Shams University: collaborator

Study Sites (1)

Poison Control Center of Ain-Shams University hospitals

Cairo, Abbasya, 11311, Egypt

Location

MeSH Terms

Interventions

Acetylcysteine; Acetylcarnitine; Ondansetron

Intervention Hierarchy (Ancestors)

Cysteine; Amino Acids, Sulfur; Sulfur Compounds; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins; Carnitine; Trimethyl Ammonium Compounds; Quaternary Ammonium Compounds; Amines; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Carbazoles; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds, 3-Ring

Central Study Contacts

Mahmoud Sakr, PhD

CONTACT

+201117922833; mahmoud.sakr@hotmail.com

Hanan Abdel Wahab, Master's

CONTACT

+201062261010; hanan.abdelwahab@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer of pharmacology

Study Record Dates

• First Submitted: August 9, 2020
• First Posted: August 12, 2020
• Study Start: October 1, 2020
• Primary Completion: October 1, 2021
• Study Completion: December 1, 2021
• Last Updated: August 12, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)