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

NCT ID: NCT04509258

Last Updated: 2020-08-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-31

Study Completion Date

2021-12-31

Brief Summary

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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

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

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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

Group Type PLACEBO_COMPARATOR

Sodium Bicarbonate Powder and ondansetron

Intervention Type DRUG

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

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

Group Type ACTIVE_COMPARATOR

N-acetyl cysteine

Intervention Type 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

Sodium Bicarbonate Powder and ondansetron

Intervention Type DRUG

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

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

Group Type ACTIVE_COMPARATOR

acetyl L-carnitine

Intervention Type 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

Sodium Bicarbonate Powder and ondansetron

Intervention Type DRUG

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

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

Group Type ACTIVE_COMPARATOR

medicated paraffin oil

Intervention Type 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

Sodium Bicarbonate Powder and ondansetron

Intervention Type DRUG

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

Interventions

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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

Intervention Type DRUG

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

Intervention Type DIETARY_SUPPLEMENT

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

Intervention Type DRUG

Sodium Bicarbonate Powder and ondansetron

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

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ain Shams University

OTHER

Sponsor Role collaborator

Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Dalia K. Zaafar

lecturer of pharmacology

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Poison Control Center of Ain-Shams University hospitals

Cairo, Abbasya, Egypt

Site Status

Countries

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Egypt

Central Contacts

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Mahmoud Sakr, PhD

Role: CONTACT

+201117922833

Hanan Abdel Wahab, Master's

Role: CONTACT

+201062261010

Facility Contacts

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Walaa Abdel Hamid, PhD

Role: primary

+201062261010

Dalia Zaafar, PhD

Role: backup

+201117922833

Other Identifiers

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R 66/2019

Identifier Type: -

Identifier Source: org_study_id

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