Alpha Lipoic Acid as an Adjuvant Treatment in Acute Phosphide Poisoning (ALA)

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.

Study Overview

• Status: Unknown
• Conditions: Toxicity
• Intervention / Treatment: Drug: Alpha Lipoic Acid (Thioctacid); Drug: Placebo (for Alpha Lipoic Acid)

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.

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

Patients (male or female, aged 12 years or older) with symptomatic acute phosphide poisoning (deliberate or accidental), with diagnosis made on the basis of:

1. The typical clinical manifestations due to and following shortly after a single exposure to phosphide.
2. Reliable identification of the compound based on the container brought by patient attendants or a subsequent confirmation by silver nitrate test for phosphine detection in stomach contents.

Exclusion Criteria:

• Patients less than 12 years of age
• Pregnant and lactating women
• Patients with ingestion or exposure to other substances in addition to phosphide.
• Patients with other major medical conditions (e.g. cardiovascular disease, renal or hepatic failure).
• Patients presenting more than 6 hours of having consumed the phosphide compound (late presenters).
• Patients treated for acute phosphide poisoning in any medical center before admission.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Alpha Lipoic Acid; Subjects in this arm will receive ALA IV, as a dose of 600 mg/12 hours.	Drug: Alpha Lipoic Acid (Thioctacid); 600 mg/12 hours, IV (in the vein); Other Names: Thioctic Acid
Placebo Comparator: Non-Alpha Lipoic Acid; Subjects in this arm will to receive standard treatment only (without Alpha Lipoic Acid, instead they will receive placebo , 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.	Drug: Placebo (for Alpha Lipoic Acid); Normal saline in syringe simulating Alpha Lipoic Acid 600mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mortality	Death Rate	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of hospital stay	Duration that patient will stay in hospital	2 years

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Need for intubation	will the patient need to be intubated or not	2 years

Collaborators and Investigators

• Sponsor: Heba Allah Ali Abd El-Halim Mabrouk
• Collaborators: Tanta University

Study record dates

Study Major Dates

• Study Start: May 1, 2016
• Primary Completion (Anticipated): January 1, 2018
• Study Completion (Anticipated): January 1, 2018

Study Registration Dates

• First Submitted: May 2, 2016
• First Submitted That Met QC Criteria: May 3, 2016
• First Posted (Estimate): May 4, 2016

Study Record Updates

• Last Update Posted (Estimate): May 10, 2016
• Last Update Submitted That Met QC Criteria: May 7, 2016
• Last Verified: May 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Chemically-Induced Disorders; Poisoning; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Protective Agents; Micronutrients; Vitamins; Antioxidants; Vitamin B Complex; Thioctic Acid
• Other Study ID Numbers: ALA-2016-CT; ALA (Registry Identifier: Alpha Lipoic Acid)