Acute Aluminum Phosphide Poisoned CasesNCT07451561
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.
A study testing Gastric lavage with paraffin oil and GIK solution in people with Acute Aluminum Phosphide Poisoned Cases, run by Sohag University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 60 years
- Conditions the study is for
- Acute Aluminum Phosphide Poisoned Cases
- What is being tested?
- Gastric lavage with paraffin oil and GIK solution
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteEgypt
- Study dates
- Mar 2026to Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Soheir A Mohammed, Professor contact
About this study
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 .
Read more
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
- Conditions
- Acute Aluminum Phosphide Poisoned Cases
- Being tested
- Gastric lavage with paraffin oil, GIK solution
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gastric lavage with paraffin oilDrug
with paraffin oil about 6 bottles (3 for lavage and 3 left in the stomach) then Nil Per Os (NPO) for 48 hrs.
GIK solutionDrug
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
| Study group | Role | What they receive |
|---|---|---|
| Control group | Active comparator | 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. Receives: Drug: Gastric lavage with paraffin oil |
| Intervention group | Active comparator | 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). Receives: Drug: GIK solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in mortality rate in acute aluminum phosphide poisoned cases admitted to intensive care unit (ICU).
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)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2026
- Study startMar 2026 (estimated)
- Primary completionMar 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Acute Aluminum Phosphide Poisoned CasesStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 74 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abeer hussien Mohamed, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07451561
- Sponsor's protocol ID
- Soh-Med--26-2-4MD
- Status last verified
- Feb 2026
- First submitted
- 23 Feb 2026
- Last updated
- 5 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Adel B, Elgharbawy NM, Shahin MM, Abo-Elfadl AA, Saad KM. Insulin-euglycemia therapy in acute aluminum phosphide poisoning: a randomized clinical trial. Clin Toxicol (Phila). 2023 Dec;61(12):1032-1039. doi: 10.1080/15563650.2023.2279495. Epub 2024 Jan 25.
PubMed 38096041Agrawal VK, Bansal A, Singh RK, Kumawat BL, Mahajan P. Aluminum phosphide poisoning: Possible role of supportive measures in the absence of specific antidote. Indian J Crit Care Med. 2015 Feb;19(2):109-12. doi: 10.4103/0972-5229.151019.
PubMed 25722553Bagherian F, Kalani N, Rahmanian F, Abiri S, Hatami N, Foroughian M, Mehramiz NJ, Shahi B. Aluminum Phosphide Poisoning Mortality Rate in Iran; a Systematic Review and Meta-Analysis. Arch Acad Emerg Med. 2021 Oct 3;9(1):e66. doi: 10.22037/aaem.v9i1.1396. eCollection 2021.
PubMed 34870232Bogale DE, Ejigu BD, Muche TA. Clinical Profile and Treatment Outcome of Aluminum Phosphide Poisoning in Felege Hiwot Referral Hospital, Northwest Ethiopia: A Retrospective Study. Open Access Emerg Med. 2021 Jun 16;13:239-248. doi: 10.2147/OAEM.S313181. eCollection 2021.
PubMed 34163261Bogle RG, Theron P, Brooks P, Dargan PI, Redhead J. Aluminium phosphide poisoning. Emerg Med J. 2006 Jan;23(1):e3. doi: 10.1136/emj.2004.015941.
PubMed 16373788
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT07451561
- Acronym / sponsor ID
- Soh-Med--26-2-4MD
- Conditions
- Acute Aluminum Phosphide Poisoned Cases
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 74 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- Mar 2026 (estimated)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 5 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Drug: Gastric lavage with paraffin oilwill 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. |
| Intervention group | Active comparator | Drug: GIK solutionwill 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). |
Who may qualify
- Ages
- 12 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gastric lavage with paraffin oilwith paraffin oil about 6 bottles (3 for lavage and 3 left in the stomach) then Nil Per Os (NPO) for 48 hrs. | Drug | Control group |
| GIK solutionbolus 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 | Drug | Intervention group |
Primary outcome
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2026.
- Background: PubMed 38096041Adel B, Elgharbawy NM, Shahin MM, Abo-Elfadl AA, Saad KM. Insulin-euglycemia therapy in acute aluminum phosphide poisoning: a randomized clinical trial. Clin Toxicol (Phila). 2023 Dec;61(12):1032-1039. doi: 10.1080/15563650.2023.2279495. Epub 2024 Jan 25.
- Background: PubMed 25722553Agrawal VK, Bansal A, Singh RK, Kumawat BL, Mahajan P. Aluminum phosphide poisoning: Possible role of supportive measures in the absence of specific antidote. Indian J Crit Care Med. 2015 Feb;19(2):109-12. doi: 10.4103/0972-5229.151019.
- Background: PubMed 34870232Bagherian F, Kalani N, Rahmanian F, Abiri S, Hatami N, Foroughian M, Mehramiz NJ, Shahi B. Aluminum Phosphide Poisoning Mortality Rate in Iran; a Systematic Review and Meta-Analysis. Arch Acad Emerg Med. 2021 Oct 3;9(1):e66. doi: 10.22037/aaem.v9i1.1396. eCollection 2021.
- Background: PubMed 34163261Bogale DE, Ejigu BD, Muche TA. Clinical Profile and Treatment Outcome of Aluminum Phosphide Poisoning in Felege Hiwot Referral Hospital, Northwest Ethiopia: A Retrospective Study. Open Access Emerg Med. 2021 Jun 16;13:239-248. doi: 10.2147/OAEM.S313181. eCollection 2021.
- Background: PubMed 16373788Bogle RG, Theron P, Brooks P, Dargan PI, Redhead J. Aluminium phosphide poisoning. Emerg Med J. 2006 Jan;23(1):e3. doi: 10.1136/emj.2004.015941.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Soheir A Mohammed, Professor contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gastric lavage with paraffin oil and GIK solution in people with Acute Aluminum Phosphide Poisoned Cases, run by Sohag University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 5 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Abeer H Mohamed, Assistant Lecturer (+20 11 13429592, abeer011116@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in mortality rate in acute aluminum phosphide poisoned cases admitted to intensive care unit (ICU). (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07451561, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2026.