NCT02760823

Alpha Lipoic Acid as an Adjuvant Treatment in Acute Phosphide Poisoning

Alpha Lipoic Acid as an Adjuvant Treatment in Acute Phosphide Poisoning: A Randomized Clinical Trial

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Heba Allah Ali Abd El-Halim Mabrouk · Academic / Other
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

Summary

The aim of this study is to evaluate efficacy and safety of Alpha Lipoic Acid(ALA) as an adjuvant in the management of patients with acute phosphide poisoning.

Detailed description

The study will be carried out following approval of the research ethical committee of Tanta Faculty of Medicine on patients admitted to The Poison Control Unit (Emergency Hospital, Tanta University and Emergency Hospital, Mansoura University) with acute phosphide poisoning in the period from January 2016 to January 2018. A written informed consent will be taken from each patient or his/her guardians (if the patient was unable to participate in the consent process). Confidentiality of the data will be maintained by making code numbers for each patient. The investigators plan to conduct a randomized clinical trial to evaluate efficacy and safety of ALA as an adjuvant in treatment of patients with acute phosphide poisoning. Fifty patients will be randomized to ALA or a non ALA in a 1:1 ratio (25 patients in each group). ALA will be given IV, as a dose of 600 mg/12 hours. Patients will be monitored and a detailed documentation of any adverse effect due to ALA therapy will be recorded. This intervention represents an added treatment to the existing standard of care. All patients will continue to receive standard treatment, which is determined by the attending physician who maintains clinical responsibility for all patients. It consists of patient resuscitation, gastric decontamination (with sodium bicarbonate, and activated charcoal \[1 g/Kg, orally\] in the first 6 hours after onset of poisoning), adequate hydration and supportive treatment. All the patients will be followed up until discharge or death. All patients will be subjected to: I. History. II. Clinical examination. III. Laboratory investigations: At admission and repeated before discharge.

Conditions

• Toxicity

Interventions

Type	Name	Description
DRUG	Alpha Lipoic Acid (Thioctacid)	600 mg/12 hours, IV (in the vein)
DRUG	Placebo (for Alpha Lipoic Acid)	Normal saline in syringe simulating Alpha Lipoic Acid 600mg

Timeline

• Start date: 2016-05-01
• Primary completion: 2018-01-01
• Completion: 2018-01-01
• First posted: 2016-05-04
• Last updated: 2016-05-10