Aluminum Phosphide PoisoningNCT04702906
Trimetazidine As a Potential Adjuvant Therapy in Acute Aluminum Phosphide Poisoning-induced Cardiotoxicity
A study testing standard treatment and trimetazidine hydrochloride "metacardia" ® 20 mg tablet in people with Aluminum Phosphide Poisoning, run by Tanta University.
Trial summary
The aim of the present study is to evaluate the potential adjuvant therapeutic effect of trimetazidine in treatment of acute AlP poisoning-induced cardiotoxicity. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aluminum Phosphide Poisoning
- What is being tested?
- standard treatment and trimetazidine hydrochloride "metacardia" ® 20 mg tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Feb 2021to Jul 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients included in this study will be diagnosed as acute aluminum phosphide poisoning by history and clinical pictures.
- Age is18 years or older.
Who cannot join
- Pregnant and lactating women.
- Patients with ingestion or exposure to other substances in addition to aluminum phosphide.
- Patients with other major medical conditions (e.g. cardiovascular disease, diabetes mellitus, renal or hepatic failure).
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Trimetazidine As a Potential Adjuvant Therapy in Acute Aluminum Phosphide Poisoning-induced Cardiotoxicity: A Randomized Controlled Clinical Trial
The aim of the present study is to evaluate the potential adjuvant therapeutic effect of trimetazidine in treatment of acute AlP poisoning-induced cardiotoxicity.
Read the detailed description
Aluminium phosphide (AlP) is an inorganic phosphide. It is used as a fumigant to protect stored grains from insects, rodents and other pests.It is a solid fumigant widely used in Egypt as a grain preservative. Its tablets are commonly used due to their low cost, high efficacy, and availability .
Toxic effects of AlP are related to phosphine gas release when AlP comes in contact with moisture or gastric acidity. Phosphine gas is rapidly absorbed from the gastrointestinal tract and lungs inhibiting cytochrome-c oxidase and oxidative phosphorylation which results in adenosine triphosphate depletion and resulting cellualr death.
The direct toxic effects of phosphine on cardiac myocytes, fluid loss and adrenal gland can induce profound circulatory collapse. Phosphides and phosphine can exert a direct corrosive effect on body tissues.
Toxic manifestations usually appear rapidly upon phosphide exposure. Impaired myocardial contractility, fluid loss, pulmonary edema, metabolic acidosis and acute renal failure are the most frequent manifestations. Disseminated intravascular coagulation and hepatic necrosis may also occur. Patients generally die due to multi-organ failure .However, myocardial damage- induced cardiovascular collapse is reported to be the primary cause of death.
Severity of manifestations depends on different factors such as dose, exposure route, and time delay before treatment initiation. Diagnosis is based on history of exposure, garlic odor of the breath, suggestive clinical manifestations and detection of phosphine gas in gastric aspirate or breath.
Treatment of acute AlP toxicity is mainly supportive as there is no specific antidote since the exact mechanism of toxicity is still unknown. The most important factor is resuscitation of shock. Many researches are directed towards finding a specific treatment for this fatal poison.
Trimetadizine is described as the first cytoprotective anti-ischemic agent developed. It has a protective of the myocardium due to its preservation of oxidative metabolism. It improves myocardial glucose utilization through inhibition of long-chain 3-ketoacyl CoA thiolase activity, which results in a reduction in fatty acid oxidation and a stimulation of glucose oxidation .
Trimetadizine reduces the tissue accumulation of malonyldialdehyde, the lipid peroxidation index, and the sodium influx related to activation of the Na+ -K + pump. Moreover, it lack of haemodynamic effects. These effects result in a decrease in the cellular accumulation of calcium and improved intracellular ATP levels).
Oral administration of the anti-ischaemic drug trimetazidine, was tried in a case report of occupational inhalation exposure to phosphine gas from AlP. It was temporally associated with clinical improvement.
- Conditions
- Aluminum Phosphide Poisoning
- Being tested
- standard treatment, trimetazidine hydrochloride "metacardia" ® 20 mg tablet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
standard treatmentOther
Standard treatment if indicated.
trimetazidine hydrochloride "metacardia" ® 20 mg tabletDrug
trimetazidine hydrochloride "metacardia" ® (20 mg three times daily produced by Global NAPI Pharmaceuticals-Egypt)
| Study group | Role | What they receive |
|---|---|---|
| control group | Active comparator | All patients will continue to receive the standard treatment, which is determined by the attending physician who maintains clinical responsibility for all patients. Conventional standard treatment included using inotropes, fluids and electrolytes resuscitation, intubation, mechanical ventilation, and antiarrhythmic agents if indicated. Receives: Other: standard treatment |
| trimetazidine group | Active comparator | The trimetazidine group will receive conventional standard treatment plus Trimetazidine dihydrochloride "metacardia" ® (20 mg three times daily produced by Pharco-Egypt) will be administered twice every 24 hours until at least treatment is no longer needed. Receives: Other: standard treatment; Drug: trimetazidine hydrochloride "metacardia" ® 20 mg tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
mortality rate
Measured: 7 days
Secondary outcomes (1)
Duration of ventilation
Duration of mechanical ventilation
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2021
- Study startFeb 2021 (estimated)
- Primary completionJun 2021 (estimated)
- Study completionJul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aluminum Phosphide PoisoningStudies of the same condition, open and under way.
- More trials run by Tanta 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nadia Helal, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04702906
- Sponsor's protocol ID
- Aluminum Phosphide Poisoning
- Status last verified
- Jan 2021
- First submitted
- 15 Dec 2020
- Last updated
- 11 Jan 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trimetazidine As a Potential Adjuvant Therapy in Acute Aluminum Phosphide Poisoning-induced Cardiotoxicity: A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT04702906
- Acronym / sponsor ID
- Aluminum Phosphide Poisoning
- Conditions
- Aluminum Phosphide Poisoning
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- Feb 2021 (estimated)
- Primary completion
- Jun 2021 (estimated)
- Study completion
- Jul 2021 (estimated)
- First posted
- 11 Jan 2021 (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.
The aim of the present study is to evaluate the potential adjuvant therapeutic effect of trimetazidine in treatment of acute AlP poisoning-induced cardiotoxicity.
Detailed description
Aluminium phosphide (AlP) is an inorganic phosphide. It is used as a fumigant to protect stored grains from insects, rodents and other pests.It is a solid fumigant widely used in Egypt as a grain preservative. Its tablets are commonly used due to their low cost, high efficacy, and availability .
Toxic effects of AlP are related to phosphine gas release when AlP comes in contact with moisture or gastric acidity. Phosphine gas is rapidly absorbed from the gastrointestinal tract and lungs inhibiting cytochrome-c oxidase and oxidative phosphorylation which results in adenosine triphosphate depletion and resulting cellualr death.
The direct toxic effects of phosphine on cardiac myocytes, fluid loss and adrenal gland can induce profound circulatory collapse. Phosphides and phosphine can exert a direct corrosive effect on body tissues.
Toxic manifestations usually appear rapidly upon phosphide exposure. Impaired myocardial contractility, fluid loss, pulmonary edema, metabolic acidosis and acute renal failure are the most frequent manifestations. Disseminated intravascular coagulation and hepatic necrosis may also occur. Patients generally die due to multi-organ failure .However, myocardial damage- induced cardiovascular collapse is reported to be the primary cause of death.
Severity of manifestations depends on different factors such as dose, exposure route, and time delay before treatment initiation. Diagnosis is based on history of exposure, garlic odor of the breath, suggestive clinical manifestations and detection of phosphine gas in gastric aspirate or breath.
Treatment of acute AlP toxicity is mainly supportive as there is no specific antidote since the exact mechanism of toxicity is still unknown. The most important factor is resuscitation of shock. Many researches are directed towards finding a specific treatment for this fatal poison.
Trimetadizine is described as the first cytoprotective anti-ischemic agent developed. It has a protective of the myocardium due to its preservation of oxidative metabolism. It improves myocardial glucose utilization through inhibition of long-chain 3-ketoacyl CoA thiolase activity, which results in a reduction in fatty acid oxidation and a stimulation of glucose oxidation .
Trimetadizine reduces the tissue accumulation of malonyldialdehyde, the lipid peroxidation index, and the sodium influx related to activation of the Na+ -K + pump. Moreover, it lack of haemodynamic effects. These effects result in a decrease in the cellular accumulation of calcium and improved intracellular ATP levels).
Oral administration of the anti-ischaemic drug trimetazidine, was tried in a case report of occupational inhalation exposure to phosphine gas from AlP. It was temporally associated with clinical improvement.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | Active comparator | Other: standard treatmentAll patients will continue to receive the standard treatment, which is determined by the attending physician who maintains clinical responsibility for all patients. Conventional standard treatment included using inotropes, fluids and electrolytes resuscitation, intubation, mechanical ventilation, and antiarrhythmic agents if indicated. |
| trimetazidine group | Active comparator | Other: standard treatment, Drug: trimetazidine hydrochloride "metacardia" ® 20 mg tabletThe trimetazidine group will receive conventional standard treatment plus Trimetazidine dihydrochloride "metacardia" ® (20 mg three times daily produced by Pharco-Egypt) will be administered twice every 24 hours until at least treatment is no longer needed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients included in this study will be diagnosed as acute aluminum phosphide poisoning by history and clinical pictures.
Key exclusion criteria (3 listed)
- Pregnant and lactating women.
- Patients with ingestion or exposure to other substances in addition to aluminum phosphide.
- Patients with other major medical conditions (e.g. cardiovascular disease, diabetes mellitus, renal or hepatic failure).
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 |
|---|---|---|
| standard treatmentStandard treatment if indicated. | Other | control group, trimetazidine group |
| trimetazidine hydrochloride "metacardia" ® 20 mg tablettrimetazidine hydrochloride "metacardia" ® (20 mg three times daily produced by Global NAPI Pharmaceuticals-Egypt) | Drug | trimetazidine group |
Primary outcome
Mortality
Time frame: 7 days
mortality rate
1 secondary outcome
Duration of ventilation
Time frame: 7 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2021.
Related trials for Aluminum Phosphide Poisoning
RecruitingPhase 3
Assessment of The Potential Therapeutic Effects of Trimetazidine on Aluminium Phosphide-Induced Cardiotoxicity as an Adjuvant Therapy: A Pilot Study
Aluminum Phosphide Poisoning
Recruiting
Potential Role of Gastric Lavage by Paraffin Oil in Acute Aluminum Phosphide Poisoning
Toxicity, Drug
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. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing standard treatment and trimetazidine hydrochloride "metacardia" ® 20 mg tablet in people with Aluminum Phosphide Poisoning, run by Tanta University.
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 2 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 11 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact nadia helal, MD (00201099752866, dr_nadia_helal86@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Jan 2021.