Clinical trial NCT04465539: The Potential Therapeutic Role of Hydroxyethyl Starch and Hydrocortisone in Acute Aluminum Phosphide Poisoning
Official title: The Potential Therapeutic Role of Hydroxyethyl Starch and Hydrocortisone in Acute Aluminum Phosphide Poisoning: A Randamized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Potential Therapeutic Role
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2020-07-10
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Aluminum phosphide (ALP) is a widely used fumigant due to its efficiency as pesticides. It is available as tablets of Celphos, Alphos or Quickphos which are known as rice tablets. Each tablet weights 3 grams and contains 56% ALP and 44% of aluminum carbonate and paraffin. The incidence of ALP poisoning increased steadily specially in developing countries . ALP poisoning is considered to be one of the major causes of suicidal poisoning owing to its wide accessibility and low cost. However, accidental poisoning may occur during occupational exposure

Detailed description: Aluminum phosphide (ALP) is a widely used fumigant due to its efficiency as pesticides. It is available as tablets of Celphos, Alphos or Quickphos which are known as rice tablets. Each tablet weights 3 grams and contains 56% ALP and 44% of aluminum carbonate and paraffin. The incidence of ALP poisoning increased steadily specially in developing countries . ALP poisoning is considered to be one of the major causes of suicidal poisoning owing to its wide accessibility and low cost. However, accidental poisoning may occur during occupational exposure.

Signs and symptoms of acute AlP poisoning include gastrointestinal, cardiovascular, hepatic, renal, and neurologic (1). Ingestion of ALP causes mild gastrointestinal (GIT) manifestations as nausea, vomiting, abdominal pain, in addition to chest tightness, hypotension, headache and dizziness. In severe cases, GIT hemorrhage, shock, severe metabolic acidosis, cardiac arrhythmia, convulsions and coma may occur. Later, signs of hepatic damage and renal insufficiency may develop.

Death usually occurs in 30-70% of cases within the first 24 hours resulting from refractory cardiogenic shock, cardiac arrhythmia, severe hypotension and metabolic acidosis.The main causes of cardiovascular collapse are increase capillary permeability, insufficient systemic vasoconstriction with low ventricular ejection fraction. On autopsy examinations, point to extravasation of fluid into the third space.

The management is exclusively supportive as gastric lavage with KMnO4 solution, treatment of hypotension and acidosis in view of the fact that there is no specific antidote available.

Eligibility criteria: Inclusion Criteria:

* Patients with severe acute aluminum phosphide poisoning
* systolic blood pressure (SBP) ≤90 mmHg
* PH ≤ 7.2
* HCO3 ≤15 meq/L
* during the first six hours of admission

Exclusion Criteria:

* Pregnant and lactating women
* Asymptomatic patients with history of acute aluminum phosphide exposure.
* Patients with co-ingestion to other substances in addition to aluminum phosphide.
* Patients with other major medical conditions (e.g. cardiovascular disease, renal or hepatic failure).
* Patients with previous medical intervention (fluid therapy and vasopressors).

Primary outcomes:
measure: mortality
timeFrame: 28 days from start of management
Secondary outcomes:
measure: Need for mechanical ventilation
timeFrame: Through study completion up to 6 months
measure: need for ICU admission
timeFrame: Through study completion up to 6 months
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Tarek Abdel Hay
state: El Gharbyia
Study officials:
References: