Toxicity Clinical Trial
Official title:
Alpha Lipoic Acid as an Adjuvant Treatment in Acute Phosphide Poisoning: A Randomized Clinical Trial
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.
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
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