NCT Number: NCT03953248
L-Carnitine as an Adjuvant Treatment in Acute Phosphide Poisoning (LC)
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.
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Conditions
Age range
12 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Early Phase 1
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Primary outcomes
-
Mortality
Time frame: 2 years
Death Rate
Secondary outcomes
-
Duration of hospital stay
Time frame: 2 years
Duration that patient will stay in hospital
Other outcomes
-
Need for intubation
Time frame: 2 years
will the patient need to be intubated or not
Sponsors and collaborators
Lead sponsor
Heba Allah Ali Abd El-Halim Mabrouk
Other
Collaborators
- Tanta University
Registry information
Official study title
L-Carnitine as an Adjuvant Treatment in Acute Phosphide Poisoning (LC): A Randomized Clinical Trial
Important dates
- Study start
- 2016
- Primary completion
- 2018
- Study completion
- 2018
- First posted
- May 16, 2019
- Registry last updated
- May 16, 2019
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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