Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03953248
Recruitment Status : Completed
First Posted : May 16, 2019
Last Update Posted : May 16, 2019
Sponsor:
Collaborator:
Tanta University
Information provided by (Responsible Party):
Heba Allah Ali Abd El-Halim Mabrouk, Kafrelsheikh University

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.

Condition or disease Intervention/treatment Phase
Toxicity Drug: L-Carnitine Early Phase 1

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: L-Carnitine as an Adjuvant Treatment in Acute Phosphide Poisoning (LC): A Randomized Clinical Trial
Actual Study Start Date : January 2016
Actual Primary Completion Date : January 2018
Actual Study Completion Date : January 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Poisoning

Arm Intervention/treatment
No Intervention: Non L-Carnitine
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
Active Comparator: L-Carnitine
Subjects in this arm will receive standard treatment in addition to LC IV, as a dose of 1 g/8 hours
Drug: L-Carnitine



Primary Outcome Measures :
  1. Mortality [ Time Frame: 2 years ]
    Death Rate


Secondary Outcome Measures :
  1. Duration of hospital stay [ Time Frame: 2 years ]
    Duration that patient will stay in hospital


Other Outcome Measures:
  1. Need for intubation [ Time Frame: 2 years ]
    will the patient need to be intubated or not



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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


Layout table for additonal information
Responsible Party: Heba Allah Ali Abd El-Halim Mabrouk, Principal Investigator, Kafrelsheikh University
ClinicalTrials.gov Identifier: NCT03953248     History of Changes
Other Study ID Numbers: LC-2018-CT
L-Carnitine ( Registry Identifier: LC )
First Posted: May 16, 2019    Key Record Dates
Last Update Posted: May 16, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Time Frame: 2 years

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No

Keywords provided by Heba Allah Ali Abd El-Halim Mabrouk, Kafrelsheikh University:
phosphide; poisoning; L-carnitine; oxidative stress

Additional relevant MeSH terms:
Layout table for MeSH terms
Poisoning
Chemically-Induced Disorders