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

Sponsors

Lead Sponsor: Cairo University

Collaborator: Ain Shams University hospitals

Source 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.

Overall Status Not yet recruiting
Start Date October 2020
Completion Date December 2021
Primary Completion Date October 2021
Phase Phase 4
Study Type Interventional
Primary Outcome
Measure Time Frame
mortality rate reduction 1 year
organ damage reduction 1 year
Enrollment 100
Condition
Intervention

Intervention Type: Drug

Intervention Name: N-acetyl cysteine

Description: 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

Arm Group Label: N- acetyl cysteine grouo

Intervention Type: Dietary Supplement

Intervention Name: acetyl L-carnitine

Description: 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

Arm Group Label: Acetyl L-carnitine group

Intervention Type: Drug

Intervention Name: medicated paraffin oil

Description: 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

Arm Group Label: Medicated paraffin oil group

Intervention Type: Drug

Intervention Name: Sodium Bicarbonate Powder and ondansetron

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

Eligibility

Criteria:

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.

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Contact

Last Name: Mahmoud Sakr, PhD

Phone: +201117922833

Email: [email protected]

Location
Facility: Contact: Contact Backup: Poison Control Center of Ain-Shams University hospitals Walaa Abdel Hamid, PhD +201062261010 [email protected]
Location Countries

Egypt

Verification Date

August 2020

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Cairo University

Investigator Full Name: Dalia K. Zaafar

Investigator Title: lecturer of pharmacology

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 4
Arm Group

Label: control group

Type: Placebo Comparator

Description: this group will have the standard and routine therapy of treatment of acute Aluminium Phosphide poisoning immediately after admission according to PCCA guidelines

Label: N- acetyl cysteine grouo

Type: Active Comparator

Description: 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

Label: Acetyl L-carnitine group

Type: Active Comparator

Description: 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

Label: Medicated paraffin oil group

Type: Active Comparator

Description: 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

Patient Data No
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Supportive Care

Masking: Single (Participant)

Source: ClinicalTrials.gov