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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03879356
Other study ID # AluminumPhosphideAssiut
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date January 1, 2016
Est. completion date March 14, 2017

Study information

Verified date March 2019
Source Assiut University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 44
Est. completion date March 14, 2017
Est. primary completion date June 30, 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years to 60 Years
Eligibility 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 Design


Related Conditions & MeSH terms

  • Detection of Different Prognostic Factors and Their Relation With the Outcome
  • Poisoning
  • Using New Protocol to Prove the Role of N-acetyl Cysteine and Adequate Supportive Measures in Aluminum Phosphide Poisoning

Intervention

Drug:
N-acetyl cysteine
effect of N-acetyl cysteine in Aluminum phosphide poisoning patients

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Assiut University

Outcome

Type Measure Description Time frame Safety issue
Primary mortality rate comparison comparison of mortality rate using the New protocol and previous mortality rate from archive records 3 days
Primary hospital stay number of days the patient stayed at hospital 3 days