The Potential Therapeutic Role of Hydroxyethyl Starch and Hydrocortisone in Acute Aluminum Phosphide Poisoning

Potential Therapeutic Role Clinical Trial

Official title:

The Potential Therapeutic Role of Hydroxyethyl Starch and Hydrocortisone in Acute Aluminum Phosphide Poisoning: A Randamized Controlled Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04465539
• Other study ID #: HES & hydrocortisone
• Status: Completed
• Phase: N/A
• Start date: July 15, 2020
• Est. completion date: March 30, 2024

Study information

• Verified date: April 2024
• Source: Tanta University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: March 30, 2024
• Est. primary completion date: February 28, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Poisoning
• Potential Therapeutic Role

Intervention

Drug:
• Hydroxyethyl Starch 130-0.4 60 MG/ML [Voluven]
Hydroxyethyl starch dose is 500 cc in 6 hours
• Hydrocortisone
Hydrocortisone dose is 200-300 mg /day intravenously
• Placebo
received the standard ALP treatment according to TUPTC protocol as follows: patient resuscitation, care of airway, breathing and circulation, gastric decontamination with 2 ampoules sodium bicarbonate (each ampoule 25 ml containing 2.1 gm sodium bicarbonate) followed by activated charcoal in dose of 1 g/Kg orally, adequate hydration, normal saline administration (0.9% Sodium Chloride IV), vasopressors IV infusions, inhalation of 100% oxygen, ranitidine IV, magnesium sulfate IV infusion and other supportive treatment.

Locations

Country	Name	City	State
Egypt	Tarek Abdel Hay	Tanta	El Gharbyia

Sponsors (1)

Lead Sponsor	Collaborator
Tanta University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	mortality	mortality rate of patients	28 days from start of management
Secondary	Need for mechanical ventilation	incidence of need for intubation and mechanical ventilation for each patient	Through study completion up to 6 months
Secondary	need for ICU admission	the incidence of need for ICU admission for each patient	Through study completion up to 6 months