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.

February 28, 2026 updated by: Abeer hussien Mohamed, Sohag University

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

Study Overview

Study Type

Interventional

Enrollment (Estimated)

74

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Soheir A Mohammed, Professor

Study Locations

      • Sohag, Egypt, 82611
        • Sohag University Hospital
        • Contact:
          • Magdy M Amin, professor

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Confirmed history of ALP ingestion and clinical symptoms and signs of toxicity.
  • Age of Cases (12 - 60 years).
  • Shocked cases (Mean arterial blood (MAP) less than 70 mmHg).
  • Presentation within 12 hours of ingestion.

Exclusion Criteria:

  • Co-ingestion of other toxins.
  • Chronic cardiac/renal/hepatic failure and diabetic patients.
  • Pregnancy.
  • Cases arriving in terminal cardiac arrest.
  • Cases refused to participate in the trial.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Control group

will receive Standard supportive care which involve: Gastric lavage with paraffin oil about 6 bottles (3 for lavage and 3 left in the stomach) then Nil Per Os (NPO) for 48 hrs.

Vasopressors (norepinephrine 0.01 - 1µg/kg/min and dopamine 4-6 µg/kg/min) the dose may be increased accordingly.

Sodium bicarbonate (at a dose of 1-2 meq/kg is used if bicarbonate level is <20 meq/L).

Antiarrhythmic drugs as amiodarone and magnesium sulfate as usual use in ICU. Other AlP poisoning supportive treatment.

with paraffin oil about 6 bottles (3 for lavage and 3 left in the stomach) then Nil Per Os (NPO) for 48 hrs.
Active Comparator: Intervention group

will receive Standard care plus the combination of: GIK: bolus of 1-3 IU/kg regular insulin together with 0.5-1 gm/kg dextrose followed by an intravenous infusion of 0.2 to 1 IU/kg/hr of regular insulin and a dextrose infusion will be started at 0.5gm/kg/hr. The dextrose infusion rate will be adjusted to maintain blood glucose between 140-180 mg/dL. Potassium will be given at dose of 20-80 meq/L of potassium chloride to maintain serum potassium at 3.5 to 4.5 meq/L. GIK will be administered via a central line (Hassanian-Moghaddam and Zamani, 2016; Adel et al., 2023).

Hydrocortisone: 200 mg Iv on presentation and every 6 hours (Singh et al., 2014).

Sevelamer: loading dose of 2.4g (3 tablets) via nasogastric tube on presentation followed by 0.8 gm (one tablet) every 8 hours (Khorshidi et al., 2025).

bolus of 1-3 IU/kg regular insulin together with 0.5-1 gm/kg dextrose followed by an intravenous infusion of 0.2 to 1 IU/kg/hr of regular insulin and a dextrose infusion will be started at 0.5gm/kg/hr. The dextrose infusion rate will be adjusted to maintain blood glucose between 140-180 mg/dL. Potassium will be given at dose of 20-80 meq/L of potassium chloride to maintain serum potassium at 3.5 to 4.5 meq/L. GIK will be administered via a central line

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change in mortality rate in acute aluminum phosphide poisoned cases admitted to intensive care unit (ICU).
Time Frame: 1 year
to assess efficacy of combination of therapy of glucose insulin potassium, hydrocortisone and sevelamer in treatment of of acute aluminum phosphide poisoned cases admitted to Intensive Care Unit (ICU)
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 1, 2026

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

March 1, 2027

Study Registration Dates

First Submitted

February 23, 2026

First Submitted That Met QC Criteria

February 28, 2026

First Posted (Actual)

March 5, 2026

Study Record Updates

Last Update Posted (Actual)

March 5, 2026

Last Update Submitted That Met QC Criteria

February 28, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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