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Completed

NCT Number: NCT04465539

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

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

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Key information

Conditions

Potential Therapeutic Role

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tarek Abdel Hay

Tanta, El Gharbyia, 31527, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Hydroxyethyl Starch 130-0.4 60 MG/ML [Voluven]

Drug

Hydroxyethyl starch dose is 500 cc in 6 hours

Hydrocortisone

Drug

Hydrocortisone dose is 200-300 mg /day intravenously

Placebo

Drug

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.

Primary outcomes

  1. mortality

    Time frame: 28 days from start of management

    mortality rate of patients

Secondary outcomes

  1. Need for mechanical ventilation

    Time frame: Through study completion up to 6 months

    incidence of need for intubation and mechanical ventilation for each patient

  2. need for ICU admission

    Time frame: Through study completion up to 6 months

    the incidence of need for ICU admission for each patient

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
Jul 10, 2020
Registry last updated
May 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.