Toxicity;ChemicalALPHNCT04192526
Serum Cholinesterase Level in Aluminum Phosphide Poisoning, the Possible Proposing Role of Atropin & Pralidoxime
An observational study of Toxicity;Chemical, run by Assiut University at 1 site in Egypt.
Trial summary
Metal phosphides are widely used as a rodenticide and insecticide and poisoning with these substances has a very high mortality. The aim of this study was to evaluate the butyrylcholinesterase (BuCh) level in poisoning with metal phosphides. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Toxicity;Chemical
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2019to 30 Jul 2020
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: cases of aluminum phosphide poisoning attending Assiut University Hospitals
Who may be able to join
None listed.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of Serum Cholinesrtrase Level in Aluminum Phosphide Poisoning Cases, the Possible Proposing Role of Atropine and Pralidoxime in Saving the Cases: Clinical and
Metal phosphides are widely used as a rodenticide and insecticide and poisoning with these substances has a very high mortality. The aim of this study was to evaluate the butyrylcholinesterase (BuCh) level in poisoning with metal phosphides.
Read the detailed description
Today, the use of pesticides in the world is considered as a recognized health It is estimated that around 30% of global suicides are due to pesticide self-poisoning . Metal phosphides pesticides are highly toxic, low cost, and are easily accessible as rodenticide agents and used for self-poisoning . aluminum phosphide (ALP) are among the most important metal phosphides. Poisoning with these agents is frequently seen in India, Srilanka and Iran. In a recent study, the incidence of fatal aluminum phosphide poisoning cases referred for phosphine analysis was 5.22 and 37.02 per million of population of Tehran, Iran in 2006 and 2013, respectively (9).The mechanism of toxicity is not clearly defined. ALP toxicity is related to the production of phosphine gas. Phosphine inhibits cytochrome c oxidase and causes mitochondrial destruction and inhibits oxidative respiration which leads to anaerobic metabolism, severe metabolic acidosis, multi-organ dysfunction and death. Phosphine can lead to severe cardiac suppression and cardiogenic shock. One of the proposed mechanisms of toxicity is the reduction of the true cholinesterase and serum cholinesterase (butyrylcholinesterase) enzyme, but usually do not show obvious clinical manifestations .
- Conditions
- Toxicity;Chemical
- Keywords
- serum cholinestrase, atropin, aluminum phosphide
What is being measured
The primary outcome is the main question the study is designed to answer.
persistent cholineastrase inhibition is one of the pathological pathway of the ALP poisoning
definite assessment of the pathogenesis of ALP helps in applying adaquqte treatment regmin
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2019
- Study start1 Dec 2019
- Primary completion30 Apr 2020
- Study completion30 Jul 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Toxicity;ChemicalStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Doaa Mohamed Abd El-Rahman, Assiut University
- Investigators
- Doaa Abd el rahman, Principal investigator, AssiutU, faculty of medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04192526
- Sponsor's protocol ID
- serum cholinestrase in AP
- Acronym
- ALPH
- Status last verified
- May 2020
- First submitted
- 6 Dec 2019
- Last updated
- 13 May 2020
- 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 13 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Serum Cholinesrtrase Level in Aluminum Phosphide Poisoning Cases, the Possible Proposing Role of Atropine and Pralidoxime in Saving the Cases: Clinical and
- ClinicalTrials.gov ID
- NCT04192526
- Acronym / sponsor ID
- ALPH / serum cholinestrase in AP
- Conditions
- Toxicity;Chemical
- Keywords
- serum cholinestrase, atropin, aluminum phosphide
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Dec 2019 (actual)
- Primary completion
- 30 Apr 2020 (actual)
- Study completion
- 30 Jul 2020 (estimated)
- First posted
- 10 Dec 2019 (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 widely used as a rodenticide and insecticide and poisoning with these substances has a very high mortality. The aim of this study was to evaluate the butyrylcholinesterase (BuCh) level in poisoning with metal phosphides.
Detailed description
Today, the use of pesticides in the world is considered as a recognized health It is estimated that around 30% of global suicides are due to pesticide self-poisoning . Metal phosphides pesticides are highly toxic, low cost, and are easily accessible as rodenticide agents and used for self-poisoning . aluminum phosphide (ALP) are among the most important metal phosphides. Poisoning with these agents is frequently seen in India, Srilanka and Iran. In a recent study, the incidence of fatal aluminum phosphide poisoning cases referred for phosphine analysis was 5.22 and 37.02 per million of population of Tehran, Iran in 2006 and 2013, respectively (9).The mechanism of toxicity is not clearly defined. ALP toxicity is related to the production of phosphine gas. Phosphine inhibits cytochrome c oxidase and causes mitochondrial destruction and inhibits oxidative respiration which leads to anaerobic metabolism, severe metabolic acidosis, multi-organ dysfunction and death. Phosphine can lead to severe cardiac suppression and cardiogenic shock. One of the proposed mechanisms of toxicity is the reduction of the true cholinesterase and serum cholinesterase (butyrylcholinesterase) enzyme, but usually do not show obvious clinical manifestations .
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- cases of aluminum phosphide poisoning attending Assiut University Hospitals
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
persistent cholineastrase inhibition is one of the pathological pathway of the ALP poisoning
Time frame: 3 months
definite assessment of the pathogenesis of ALP helps in applying adaquqte treatment regmin
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2020.
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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.
Doaa Abd el rahman principal investigator
AssiutU, faculty of medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Toxicity;Chemical, run by Assiut 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 0 inclusion and 1 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 13 May 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
persistent cholineastrase inhibition is one of the pathological pathway of the ALP poisoning (time frame: 3 months). 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 13 May 2020; AzTrials last refreshed its copy on 7 Nov 2026.