A Phase 4 interventional study of N-acetyl cysteine and acetyl L-carnitine in the Study Focus to Improve the Standard of Care Used for Aluminuim Phosphide Poisoning and to Save Patients With the Minimal Organ Damage, sponsored by Cairo University. Status unknown at 1 site in Egypt. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-08-12.
Sponsored by Cairo University · Phase 4, Interventional, and Supportive care
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.
209 studies on the registry are indexed under Poisoning; 26 are open to participants now.
This study's planned enrollment of 100 is above the median of 72 across 104 interventional studies indexed under Poisoning.
Browse Poisoning studies →Cairo University is the lead sponsor of 4,780 studies on the registry; 1,427 are open to participants now.
Of its 36 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.
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Exclusion Criteria:
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 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 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
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
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
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
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
standard of care for treatment of aluminuim phosphide is provided for patients poisoned with aluminuim phosphide
mortality rate reduction
the primary end point is to lower the mortality rate for patients poisoned with aluminium phosphide pellets
Time frame: 1 year
organ damage reduction
another primary end point is to reduce organ damage and injury for survivors
Time frame: 1 year
Plan to share: No — individual paticipant data is decided not to be shared for the privacy of the patients as patients in each group will be coded in numbers instead of their names
No publications or documents are linked to this record.
This study is status unknown, as verified in Aug 2020. You cannot join it, but the record below documents what was studied.
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Cairo University