- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03879356
Supportive Measures in Treatment of Aluminum Phosphide Poisoning
Supportive Measures in Treatment of Aluminum Phosphide Poisoning as a Trial to Reduce Mortality at Assiut University Hospital
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Aluminum phosphide poisoning is a major problem, accounting for many Emergency Unit visits and hospitalization, the incidence of aluminum phosphide poisoning increasing in the last few years.
ALP is used as pesticides for many years to protect grains in stores and during its transportation. The availability of these tablets and their low cost make it an easy and common method of suicide in our country with the increasing incidence of social and financial problems that face the youth.
In management, the main objective is to provide effective oxygenation, ventilation, and circulation until phosphine is excreted. All patients of severe ALP poisoning require continuous invasive hemodynamic monitoring and early resuscitation with fluid and vasoactive agents. N- acetylcysteine as an antioxidant and cytoprotective agent reduces myocardial oxidative injury and increase survival time. Magnesium sulfate helps in scavenging free radicals through glutathione (GSH) recovery hence is effective as a parenteral antioxidant in this poisoning as well as has been tried for its general membrane stabilizing effect in cardiac cells .
Death after 24 hours occurs usually owing to shock, cardiac arrhythmia, metabolic acidosis, and acute respiratory distress syndrome.
Study Type
Enrollment (Actual)
Phase
- Phase 4
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- All the cases with the primary diagnosis of Aluminum phosphide toxicity will be included in the study.
- Willing and able to comply with the study procedures and provide written informed consent to participate in the study.
Exclusion Criteria:
- Patients with a history of any chronic disease (renal and hepatic).
- Patients refuse to participate in the study.
- Aged less than 18 years
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Aluminum phosphide patients
effect of N-acetyl cysteine and supportive measures in outcome of aluminum phosphide poisoning cases
|
effect of N-acetyl cysteine in Aluminum phosphide poisoning patients
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
mortality rate comparison
Time Frame: 3 days
|
comparison of mortality rate using the New protocol and previous mortality rate from archive records
|
3 days
|
hospital stay
Time Frame: 3 days
|
number of days the patient stayed at hospital
|
3 days
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AluminumPhosphideAssiut
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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