Alpha Lipoic Acid as an Adjuvant Treatment in Acute Phosphide Poisoning
ALA
2 other identifiers
interventional
50
0 countries
N/A
Brief Summary
The aim of this study is to evaluate efficacy and safety of Alpha Lipoic Acid(ALA) as an adjuvant in the management of patients with acute phosphide poisoning.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started May 2016
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2016
CompletedFirst Submitted
Initial submission to the registry
May 2, 2016
CompletedFirst Posted
Study publicly available on registry
May 4, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2018
CompletedMay 10, 2016
May 1, 2016
1.7 years
May 2, 2016
May 7, 2016
Conditions
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)
Alpha Lipoic Acid
ACTIVE COMPARATORSubjects in this arm will receive ALA IV, as a dose of 600 mg/12 hours.
Non-Alpha Lipoic Acid
PLACEBO COMPARATORSubjects in this arm will to receive standard treatment only (without Alpha Lipoic Acid, instead they will receive placebo , which is determined by the attending physician who maintains clinical responsibility for all patients. 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.
Interventions
600 mg/12 hours, IV (in the vein)
Normal saline in syringe simulating Alpha Lipoic Acid 600mg
Eligibility Criteria
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Heba Allah Ali Abd El-Halim Mabrouklead
- Tanta Universitycollaborator
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- 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 2, 2016
First Posted
May 4, 2016
Study Start
May 1, 2016
Primary Completion
January 1, 2018
Study Completion
January 1, 2018
Last Updated
May 10, 2016
Record last verified: 2016-05