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

Phase 4

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

• Registration Number: NCT04509258
• Lead Sponsor: Cairo University

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-08
• Study First Submitted: 2020-08-09
• Study First Submitted QC: 2020-08-09
• Last Update Submitted: 2020-08-09
• Study First Posted: 2020-08-12
• Last Update Posted: 2020-08-12
• Study Start: 2020-10
• Primary Completion: 2021-10
• Study Completion: 2021-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
N- acetyl cysteine grouo	Sodium Bicarbonate Powder and ondansetron	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
Medicated paraffin oil group	Sodium Bicarbonate Powder and ondansetron	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
N- acetyl cysteine grouo	N-acetyl cysteine	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
Acetyl L-carnitine group	Sodium Bicarbonate Powder and ondansetron	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
Acetyl L-carnitine group	acetyl L-carnitine	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
control group	Sodium Bicarbonate Powder and ondansetron	this group will have the standard and routine therapy of treatment of acute Aluminium Phosphide poisoning immediately after admission according to PCCA guidelines
Medicated paraffin oil group	medicated paraffin oil	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

Primary Outcome Measures

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

Trial Locations

Locations (1)

Poison Control Center of Ain-Shams University hospitals; 🇪🇬 Cairo, Abbasya, Egypt