Alpha Lipoic Acid as an Adjuvant Treatment in Acute Phosphide Poisoning

NCT ID: NCT02760823

Last Updated: 2016-05-10

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-05-31
• Study Completion Date: 2018-01-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: PLACEBO_COMPARATOR

Placebo (for Alpha Lipoic Acid)

Intervention Type: DRUG

Normal saline in syringe simulating Alpha Lipoic Acid 600mg

Alpha Lipoic Acid

Subjects in this arm will receive ALA IV, as a dose of 600 mg/12 hours.

Group Type: ACTIVE_COMPARATOR

Alpha Lipoic Acid (Thioctacid)

Intervention Type: DRUG

600 mg/12 hours, IV (in the vein)

Interventions

Alpha Lipoic Acid (Thioctacid)

600 mg/12 hours, IV (in the vein)

Intervention Type: DRUG

Placebo (for Alpha Lipoic Acid)

Normal saline in syringe simulating Alpha Lipoic Acid 600mg

Intervention Type: DRUG

Other Intervention Names

Thioctic Acid

Eligibility Criteria

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.

• Minimum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tanta University

OTHER

Sponsor Role: collaborator

Heba Allah Ali Abd El-Halim Mabrouk

OTHER

Sponsor Role: lead

Responsible Party

Heba Allah Ali Abd El-Halim Mabrouk

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Other Identifiers

ALA

Identifier Type: REGISTRY

Identifier Source: secondary_id

ALA-2016-CT

Identifier Type: -

Identifier Source: org_study_id