Supportive Measures in Treatment of Aluminum Phosphide Poisoning
Primary Purpose
Detection of Different Prognostic Factors and Their Relation With the Outcome, Using New Protocol to Prove the Role of N-acetyl Cysteine and Adequate Supportive Measures in Aluminum Phosphide Poisoning
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
N-acetyl cysteine
Sponsored by
About this trial
This is an interventional treatment trial for Detection of Different Prognostic Factors and Their Relation With the Outcome focused on measuring Aluminum phosphide, N-acetylcystein, Assiut, prognostic factors
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Aluminum phosphide patients
Arm Description
effect of N-acetyl cysteine and supportive measures in outcome of aluminum phosphide poisoning cases
Outcomes
Primary Outcome Measures
mortality rate comparison
comparison of mortality rate using the New protocol and previous mortality rate from archive records
hospital stay
number of days the patient stayed at hospital
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03879356
Brief Title
Supportive Measures in Treatment of Aluminum Phosphide Poisoning
Official Title
Supportive Measures in Treatment of Aluminum Phosphide Poisoning as a Trial to Reduce Mortality at Assiut University Hospital
Study Type
Interventional
2. Study Status
Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
January 1, 2016 (Actual)
Primary Completion Date
June 30, 2016 (Actual)
Study Completion Date
March 14, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Aluminum phosphide poisoning (ALP) is a global public health problem, and self-poisoning accounts for one-third of the world's suicide rate. In fact, in some parts of developing countries, pesticide poisoning causes more deaths than infection. ALP is very common in our government and the prognosis of the cases is usually so bad. Toxicity by ALP is caused by the liberation of phosphine gas, which causes cell hypoxia due to inhibition of oxidative phosphorylation leading to circulatory failure.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Detection of Different Prognostic Factors and Their Relation With the Outcome, Using New Protocol to Prove the Role of N-acetyl Cysteine and Adequate Supportive Measures in Aluminum Phosphide Poisoning
Keywords
Aluminum phosphide, N-acetylcystein, Assiut, prognostic factors
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
44 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Aluminum phosphide patients
Arm Type
Other
Arm Description
effect of N-acetyl cysteine and supportive measures in outcome of aluminum phosphide poisoning cases
Intervention Type
Drug
Intervention Name(s)
N-acetyl cysteine
Intervention Description
effect of N-acetyl cysteine in Aluminum phosphide poisoning patients
Primary Outcome Measure Information:
Title
mortality rate comparison
Description
comparison of mortality rate using the New protocol and previous mortality rate from archive records
Time Frame
3 days
Title
hospital stay
Description
number of days the patient stayed at hospital
Time Frame
3 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
12. IPD Sharing Statement
Learn more about this trial
Supportive Measures in Treatment of Aluminum Phosphide Poisoning
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