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

Primary Purpose

Toxicity

Status
Completed
Phase
Early Phase 1
Locations
Study Type
Interventional
Intervention
L-Carnitine
Sponsored by
Heba Allah Ali Abd El-Halim Mabrouk
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Toxicity focused on measuring phosphide; poisoning; L-carnitine; oxidative stress

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    No Intervention

    Active Comparator

    Arm Label

    Non L-Carnitine

    L-Carnitine

    Arm Description

    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

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

    Outcomes

    Primary Outcome Measures

    Mortality
    Death Rate

    Secondary Outcome Measures

    Duration of hospital stay
    Duration that patient will stay in hospital

    Full Information

    First Posted
    May 14, 2019
    Last Updated
    May 14, 2019
    Sponsor
    Heba Allah Ali Abd El-Halim Mabrouk
    Collaborators
    Tanta University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03953248
    Brief Title
    L-Carnitine as an Adjuvant Treatment in Acute Phosphide Poisoning (LC)
    Official Title
    L-Carnitine as an Adjuvant Treatment in Acute Phosphide Poisoning (LC): A Randomized Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2016 (Actual)
    Primary Completion Date
    January 2018 (Actual)
    Study Completion Date
    January 2018 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Heba Allah Ali Abd El-Halim Mabrouk
    Collaborators
    Tanta University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Toxicity
    Keywords
    phosphide; poisoning; L-carnitine; oxidative stress

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Early Phase 1
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    50 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Non L-Carnitine
    Arm Type
    No Intervention
    Arm Description
    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
    Arm Title
    L-Carnitine
    Arm Type
    Active Comparator
    Arm Description
    Subjects in this arm will receive standard treatment in addition to LC IV, as a dose of 1 g/8 hours
    Intervention Type
    Drug
    Intervention Name(s)
    L-Carnitine
    Primary Outcome Measure Information:
    Title
    Mortality
    Description
    Death Rate
    Time Frame
    2 years
    Secondary Outcome Measure Information:
    Title
    Duration of hospital stay
    Description
    Duration that patient will stay in hospital
    Time Frame
    2 years
    Other Pre-specified Outcome Measures:
    Title
    Need for intubation
    Description
    will the patient need to be intubated or not
    Time Frame
    2 years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    12 Years
    Accepts Healthy Volunteers
    No
    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: 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

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Time Frame
    2 years

    Learn more about this trial

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

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