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

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

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04509258
• Other study ID #: R 66/2019
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: October 2020
• Est. completion date: December 2021

Study information

• Verified date: August 2020
• Source: Cairo University
• Contact: Mahmoud Sakr, PhD
• Phone: +201117922833
• Email: mahmoud.sakr[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: December 2021
• Est. primary completion date: October 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

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

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

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
• Sodium Bicarbonate Powder and ondansetron
standard of care for treatment of aluminuim phosphide is provided for patients poisoned with aluminuim phosphide

Locations

Country	Name	City	State
Egypt	Poison Control Center of Ain-Shams University hospitals	Cairo	Abbasya

Sponsors (2)

Lead Sponsor	Collaborator
Cairo University	Ain Shams University hospitals

Country where clinical trial is conducted

Egypt, 

Outcome

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