L-Carnitine as an Adjuvant Treatment in Acute Phosphide Poisoning (LC)

Early Phase 1

Completed

• Conditions: Toxicity
• Interventions: Drug: L-Carnitine

• Registration Number: NCT03953248
• Lead Sponsor: Heba Allah Ali Abd El-Halim Mabrouk

Brief Summary

The aim of this study was 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 was carried out following approval of the research ethical committee of Tanta Faculty of Medicine on patients admitted to The Poison Control Unit (Emergency Hospitals, Tanta and Mansoura Universities) with acute phosphide poisoning in the period from January 2016 to January 2018. A written informed consent was taken from each patient or his/her guardians (if the patient was unable to participate in the consent process). Confidentiality of the data was maintained by making code numbers for each patient. The investigators planned to conduct a randomized clinical trial to evaluate efficacy and safety of LC as an adjuvant in treatment of patients with acute phosphide poisoning. Fifty patients was randomized to LC or a non LC in a 1:1 ratio (25 patients in each group). LC was given IV, as a dose of 1 g/8 hours. Patients was monitored and a detailed documentation of any adverse effect due to LC therapy was recorded.

This intervention represented an added treatment to the existing standard of care. All patients will continue to receive standard treatment, which was determined by the attending physician who maintained clinical responsibility for all patients. It consisted 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 was followed up until discharge or death. All patients was subjected to:

I. History. II. Clinical examination. III. Laboratory investigations: At admission and repeated before discharge.

Study Timeline

• Study Start: 2016-01
• Primary Completion: 2018-01
• Study Completion: 2018-01
• Status Verified: 2019-05
• Study First Submitted: 2019-05-14
• Study First Submitted QC: 2019-05-14
• Last Update Submitted: 2019-05-14
• Study First Posted: 2019-05-16
• Last Update Posted: 2019-05-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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:

The typical clinical manifestations due to and following shortly after a single exposure to phosphide.

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
L-Carnitine	L-Carnitine	Subjects in this arm will receive standard treatment in addition to LC IV, as a dose of 1 g/8 hours

Primary Outcome Measures

Name	Time	Method
Mortality	2 years	Death Rate

Secondary Outcome Measures

Name	Time	Method
Duration of hospital stay	2 years	Duration that patient will stay in hospital