Alpha Lipoic Acid as an Adjuvant Treatment in Acute Phosphide Poisoning

Toxicity Clinical Trial

— ALA  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02760823
• Other study ID #: ALA-2016-CT
• Secondary ID: ALA
• Status: Not yet recruiting
• Phase: Phase 2
• First received: May 2, 2016
• Last updated: May 3, 2016
• Start date: May 2016
• Est. completion date: January 2018

Study information

• Verified date: May 2016
• Source: Kafrelsheikh University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt: Ministry of Higher Education
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: January 2018
• Est. primary completion date: January 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Toxicity

Intervention

Drug:
• Alpha Lipoic Acid (Thioctacid)
600 mg/12 hours, IV (in the vein)
• Placebo (for Alpha Lipoic Acid)
Normal saline in syringe simulating Alpha Lipoic Acid 600mg

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Heba Allah Ali Abd El-Halim Mabrouk	Tanta University

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Need for intubation	will the patient need to be intubated or not	2 years	No
Primary	Mortality	Death Rate	2 years	Yes
Secondary	Duration of hospital stay	Duration that patient will stay in hospital	2 years	No