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

NCT03953248 | Completed Early Phase 1

• 2 other identifiers: LC-2018-CTL-Carnitine
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Toxicity

Keywords

phosphide; poisoning; L-carnitine; oxidative stress

Outcome Measures

Primary Outcomes (1)

• Mortality

  Death Rate

  2 years

Secondary Outcomes (1)

• Duration of hospital stay

  2 years

Other Outcomes (1)

• Need for intubation

  2 years

Study Arms (2)

Non L-Carnitine

NO INTERVENTION

Subjects in this arm will receive standard treatment only (without LC). 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

L-Carnitine

ACTIVE COMPARATOR

Subjects in this arm will receive standard treatment in addition to LC IV, as a dose of 1 g/8 hours

Drug: L-Carnitine

Interventions

L-Carnitine DRUG

L-Carnitine

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Heba Allah Ali Abd El-Halim Mabrouk: lead
• Tanta University: collaborator

MeSH Terms

Conditions

Poisoning

Interventions

Carnitine

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders

Intervention Hierarchy (Ancestors)

Trimethyl Ammonium Compounds; Quaternary Ammonium Compounds; Amines; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 14, 2019
• First Posted: May 16, 2019
• Study Start: January 1, 2016
• Primary Completion: January 1, 2018
• Study Completion: January 1, 2018
• Last Updated: May 16, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: 2 years