Ignite Creation Date:
2026-03-26 @ 3:14 PM
Ignite Modification Date:
2026-03-31 @ 4:49 AM
Study NCT ID:
NCT07451561
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-05
First Post:
2026-02-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Role of Combination Therapy of Glucose Insulin Potassium Infusion (GIK), Intravenous Hydrocortisone and Oral Sevelamer in Treatment of Acute Aluminum Phosphide Poisoned Cases Admitted to Intensive Care Unit (ICU) at Sohag University Hospitals.
Sponsor:
Sohag University
Organization:
Study Overview
Official Title:
Role of Combination Therapy of Glucose Insulin Potassium Infusion (GIK), Intravenous Hydrocortisone and Oral Sevelamer in Treatment of Acute Aluminum Phosphide Poisoned Cases Admitted to Intensive Care Unit (ICU) at Sohag University Hospitals.
Status:
NOT_YET_RECRUITING
Status Verified Date:
2026-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Metal phosphides are commonly utilized for safeguarding stored grains due to their desirable characteristics. They have high potency and the ability to combat different pests and produce non-toxic residues in crops .
In countries like Iran, India, and Egypt, metal phosphides are extensively employed in agriculture. Some examples of metal phosphides are aluminum phosphide (ALP), zinc phosphide, magnesium phosphide, and calcium phosphide .
ALP poisoning is a prevalent method for suicide in most of developing countries such as North India, Iran, and Egypt . ALP poisoning is becoming more common in Egypt, and poison control centers are seeing an increase in cases .
ALP which is a potent poison with an oral LD50 of 11.5 mg/kg, is utilized as an insecticide, rodenticide, and fumigant. It is available in the form of tablets, commonly referred to as rice tablets or wheat bills. The rice tablet weighs three grams and contains 56% ALP and 44% aluminum carbonate. When it comes into contact with moisture, it releases one gram of Phosphine (PH3) .
PH3 is rapidly absorbed from the respiratory or gastrointestinal tract to reach the systemic circulation. PH3 is a toxic substance that can cause various harmful effects .
The cause of hypotension in ALP poisoning is thought to be due to the direct toxic effects of phosphine on cardiac myocytes, fluid loss and adrenal gland damage .
PH3 causes collapse of the cardiovascular system, damage to the lungs, and liver dysfunction. Additionally, it can lead to significant imbalances in the body's acid-base and electrolyte levels, resulting in conditions such as metabolic acidosis and hypokalemia As a result, fatalities resulting from metal phosphide exposure are usually caused by a combination of cardiogenic shock, metabolic acidosis, acute pulmonary edema, and liver failure that are difficult to treat There is no known antidote for ALP poisoning, so treatment is only supportive. The success of treatment depends on the severity of the poisoning and how quickly the patient receives medical attention Although no specific antidote for ALP poisoning is available, glucose-insulin-potassium (GIK) infusion precipitating hyperinsulinemia-euglycemia. It is supposed to improve cell carbohydrate metabolism, increases both cardiac inotropy and systemic vascular resistance, and corrects acidosis. As carbohydrates are preferable fuel substrates of the myocardium under stressful conditions. GIK infusion assists in enhanced uptake of carbohydrates and, therefore, results in improved cardiac function
GIK infusion therapy has been advised in the additional management of ischaemia and reperfusion disturbances in ischaemic heart diseases. GIK therapy has been reported to be beneficial in cardiac surgeries.Although the GIK regime, along with supportive care, results in a longer duration of hospital stay, the ultimate outcome of the results is beneficial Adrenal insufficiency may occur as a result of shock; thus, a hydrocortisone infusion is given. Hydrocortisone combats shock; reduces the dose of dopamine; and it additionally checks capillary leakage in the lungs to prevent ARDS Use of hydrocortisone in treatment of shocked patients has a promising outcome as it stabilizes cell membranes, reduces systemic inflammation, and helps manage refractory hypotension Sevelamer (SVLM) is approved by the US Food and Drug Administration for the treatment of hyperphosphatemia in patients with chronic kidney disease or end-stage renal disease (De Santi et al., 2024).
Sevelamer is being "repurposed" as a potential oral antidote for treating aluminum phosphide poisoning. Sevelamer may serve as an effective antidote by its interaction with phosphine gas.
While GIK and Hydrocortisone address the effects of the poison (shock and metabolic collapse), Sevelamer is unique because it may directly target and neutralize the toxic phosphine gas itself
In countries like Iran, India, and Egypt, metal phosphides are extensively employed in agriculture. Some examples of metal phosphides are aluminum phosphide (ALP), zinc phosphide, magnesium phosphide, and calcium phosphide .
ALP poisoning is a prevalent method for suicide in most of developing countries such as North India, Iran, and Egypt . ALP poisoning is becoming more common in Egypt, and poison control centers are seeing an increase in cases .
ALP which is a potent poison with an oral LD50 of 11.5 mg/kg, is utilized as an insecticide, rodenticide, and fumigant. It is available in the form of tablets, commonly referred to as rice tablets or wheat bills. The rice tablet weighs three grams and contains 56% ALP and 44% aluminum carbonate. When it comes into contact with moisture, it releases one gram of Phosphine (PH3) .
PH3 is rapidly absorbed from the respiratory or gastrointestinal tract to reach the systemic circulation. PH3 is a toxic substance that can cause various harmful effects .
The cause of hypotension in ALP poisoning is thought to be due to the direct toxic effects of phosphine on cardiac myocytes, fluid loss and adrenal gland damage .
PH3 causes collapse of the cardiovascular system, damage to the lungs, and liver dysfunction. Additionally, it can lead to significant imbalances in the body's acid-base and electrolyte levels, resulting in conditions such as metabolic acidosis and hypokalemia As a result, fatalities resulting from metal phosphide exposure are usually caused by a combination of cardiogenic shock, metabolic acidosis, acute pulmonary edema, and liver failure that are difficult to treat There is no known antidote for ALP poisoning, so treatment is only supportive. The success of treatment depends on the severity of the poisoning and how quickly the patient receives medical attention Although no specific antidote for ALP poisoning is available, glucose-insulin-potassium (GIK) infusion precipitating hyperinsulinemia-euglycemia. It is supposed to improve cell carbohydrate metabolism, increases both cardiac inotropy and systemic vascular resistance, and corrects acidosis. As carbohydrates are preferable fuel substrates of the myocardium under stressful conditions. GIK infusion assists in enhanced uptake of carbohydrates and, therefore, results in improved cardiac function
GIK infusion therapy has been advised in the additional management of ischaemia and reperfusion disturbances in ischaemic heart diseases. GIK therapy has been reported to be beneficial in cardiac surgeries.Although the GIK regime, along with supportive care, results in a longer duration of hospital stay, the ultimate outcome of the results is beneficial Adrenal insufficiency may occur as a result of shock; thus, a hydrocortisone infusion is given. Hydrocortisone combats shock; reduces the dose of dopamine; and it additionally checks capillary leakage in the lungs to prevent ARDS Use of hydrocortisone in treatment of shocked patients has a promising outcome as it stabilizes cell membranes, reduces systemic inflammation, and helps manage refractory hypotension Sevelamer (SVLM) is approved by the US Food and Drug Administration for the treatment of hyperphosphatemia in patients with chronic kidney disease or end-stage renal disease (De Santi et al., 2024).
Sevelamer is being "repurposed" as a potential oral antidote for treating aluminum phosphide poisoning. Sevelamer may serve as an effective antidote by its interaction with phosphine gas.
While GIK and Hydrocortisone address the effects of the poison (shock and metabolic collapse), Sevelamer is unique because it may directly target and neutralize the toxic phosphine gas itself
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: