Pesticide PoisoningNCT05310188
Cholinesterase, Amylase, Lipase and Neutrophil-to-lymphocyte Ratio in Acute Pesticide Poisoning Cases
An observational study of Pesticide Poisoning, run by Assiut University.
Trial summary
To estimate diagnostic levels of amylase, lipase, pseudocholinestrase and neutrophili lymphocytic ratio to different pesticide poisoning. In addition to detect prognostic values of theses enzymes \& NLR and its relation to the outcome of all pesticide poisoning. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pesticide Poisoning
- What is being tested?
- pseudocholinesterease
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Apr 2022to Mar 2023
- 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
- Child, Adult, Older adult
Study population: * Sociodemographic criteria: age, gender, residence, occupation, level of education, * Toxicity associated data: mode of exposure, time of exposure, symptoms appear, any measures done to reduce the toxicity before reaching the hospital * Medical history (HR, BP, kidney function, liver function and blood glucose level) * Clinical lab result of pseudocholinesterase, amylase, lipase and neutrophil-to-lymphocyte ratio at three times. * the first with 6 hrs. of admission * the second after 24 hrs. of the treatment regimen taken * the third after 48 hrs
Who may be able to join
- All ages
- Both sex
- Any possible route of exposure to pesticides
Who cannot join
- Exposure to medications or toxic chemicals other than pesticides.
- Patients with chronic comorbidities, including liver cirrhosis, symptomatic heart failure, end stage CKD(on regular hemodialysis) and COPD.
- Patients with gallstone history or DM
- Recent abdominal trauma
- Open abdominal surgery within one year ago
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Diagnostic and Prognostic Values of Cholinesterase, Amylase, Lipase and Neutrophil-to-lymphocyte Ratio in Acute Pesticide Poisoning Cases
To estimate diagnostic levels of amylase, lipase, pseudocholinestrase and neutrophili lymphocytic ratio to different pesticide poisoning.
In addition to detect prognostic values of theses enzymes \& NLR and its relation to the outcome of all pesticide poisoning.
To assess descriptive sociodemographic criteria of these poisoned cases, mode of toxicity, type of pesticide poisoning at emergency room, any other associated toxicity as well as the clinical outcome.
Read the detailed description
Acute pesticide poisoning is a global health problem responsible for majority of deaths in poisoning cases.
There is a study estimated that about 385 million cases of unintentional acute pesticide poisoning occur annually world-wide including about 11,000 fatalities.
Thirty percent of global suicides are due to pesticide poisoning as they are of low cost and easily accessible.
Most common suicidal pesticide are classified according to WHO to organophosphorus insecticides, carbamate insecticide, and methyl parathion /or the herbicide paraquat.
. Aluminum phosphide(ALP) becomes one of the commonest causes of poisoning. It is extremely toxic after self-poisoning, with a case fatality often exceeding 70% after ingestion.
Severe poisoning also has the potential to induce multi-organ failure. The exact site or mechanism of its action has not been proved in humans. Rather than targeting a single organ to cause gross damage.
organophosphorus pesticides inhibit acetylcholine esterase enzyme so that lead to accumulation of Ach and muscarinic, nicotinic and central nervous system (CNS) receptor overstimulation. The severity of acute poisoning depends on level of cholinesterase.
Detection of pseudocholinestrase is a good biomarker and the most specific lab test of acute pesticide poisoning.
There is a relative relationship between plasma cholinesterase and manifestation and final outcome so that level of PChE is a good prognostic value and could help in treatment plans.
Cholinergic stimulation of pancreas leads to hyperamylasemia so amylase could be used as a prognostic tool of acute pesticide poisoning, lipase can be helpful with amylase for early detect of pancreatitis as well as determination of severity of poisoning.
The neutrophil-to-lymphocyte ratio (NLR) is an independent predictor of short- and long-term mortality in critically ill patients, and measurement is simple, cheap, and fast Furthermore, the NLR is a powerful prognostic predictor of cardiovascular affection, acute ischemic stroke, and many other diseases. So high NLR is associated with the risk of mortality of acute toxicity.
laboratory evaluation through using rapid, simple, cheap tests plays an important and vital role for confirmation of poisoning, diagnosing the first acute organ damage as well as assessing the severity of poisoning.
Emergency physicians can help in improvement of these patient and reduce deaths by accurate assessment of lab markers.
- Conditions
- Pesticide Poisoning
- Being tested
- pseudocholinesterease
- Keywords
- cholinesterease, lipase, amylase, NL ratio
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pseudocholinestereaseDiagnostic test
Also called lipase, NLR, amylase
blood samples
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic and prognostic values of cholinesterase in acute pesticide poisoning cases
clinical lab result of pseudocholinesterase
Measured: baseline
diagnostic and prognostic value of amylase in acute pesticide poisoning cases
blood level of amylase
Measured: baseline
diagnostic and prognostic value of lipase in acute pesticide poisoning cases
blood level of lipase
Measured: baseline
diagnostic and prognostic value of neutrophil-to-lymphocyte ratio in acute pesticide poisoning case
blood level of neutrophil-to-lymphocyte ratio
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2022
- Study startApr 2022 (estimated)
- Primary completionFeb 2023 (estimated)
- Study completionMar 2023 (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 Pesticide PoisoningStudies 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Asmaa AbouBakr Ahmed, Assiut University
- Investigators
- Doaa Mohammed Abd EL-Rahman, Ass.Prof, Study director, Assiut UniversityHanan Sharaf El_Deen Mohammed, Ass.prof, Study director, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05310188
- Sponsor's protocol ID
- Acute pesticide poisoning
- Status last verified
- Apr 2022
- First submitted
- 1 Mar 2022
- Last updated
- 4 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Afzali S, Taheri SK, Seifrabiei M. Butyrylcholinesterase level in poisoned patients with phosphide compounds. Caspian J Intern Med. 2019 Fall;10(4):458-462. doi: 10.22088/cjim.10.4.458.
PubMed 31814946Boedeker W, Watts M, Clausing P, Marquez E. The global distribution of acute unintentional pesticide poisoning: estimations based on a systematic review. BMC Public Health. 2020 Dec 7;20(1):1875. doi: 10.1186/s12889-020-09939-0.
PubMed 33287770Mu Y, Hu B, Gao N, Pang L. Prognostic value of the neutrophil-to-lymphocyte ratio in acute organophosphorus pesticide poisoning. Open Life Sci. 2021 Jul 15;16(1):703-710. doi: 10.1515/biol-2021-0069. eCollection 2021.
PubMed 34307885Mehrpour O, Jafarzadeh M, Abdollahi M. A systematic review of aluminium phosphide poisoning. Arh Hig Rada Toksikol. 2012 Mar;63(1):61-73. doi: 10.2478/10004-1254-63-2012-2182.
PubMed 22450207Dungdung A, Kumar A, Kumar B, Preetam M, Tara RK, Saba MK. Correlation and prognostic significance of serum amylase, serum lipase, and plasma cholinesterase in acute organophosphorus poisoning. J Family Med Prim Care. 2020 Apr 30;9(4):1873-1877. doi: 10.4103/jfmpc.jfmpc_205_20. eCollection 2020 Apr.
PubMed 32670933
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic and Prognostic Values of Cholinesterase, Amylase, Lipase and Neutrophil-to-lymphocyte Ratio in Acute Pesticide Poisoning Cases
- ClinicalTrials.gov ID
- NCT05310188
- Acronym / sponsor ID
- Acute pesticide poisoning
- Conditions
- Pesticide Poisoning
- Keywords
- cholinesterease, lipase, amylase, NL ratio
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Apr 2022 (estimated)
- Primary completion
- Feb 2023 (estimated)
- Study completion
- Mar 2023 (estimated)
- First posted
- 4 Apr 2022 (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.
To estimate diagnostic levels of amylase, lipase, pseudocholinestrase and neutrophili lymphocytic ratio to different pesticide poisoning.
In addition to detect prognostic values of theses enzymes \& NLR and its relation to the outcome of all pesticide poisoning.
To assess descriptive sociodemographic criteria of these poisoned cases, mode of toxicity, type of pesticide poisoning at emergency room, any other associated toxicity as well as the clinical outcome.
Detailed description
Acute pesticide poisoning is a global health problem responsible for majority of deaths in poisoning cases.
There is a study estimated that about 385 million cases of unintentional acute pesticide poisoning occur annually world-wide including about 11,000 fatalities.
Thirty percent of global suicides are due to pesticide poisoning as they are of low cost and easily accessible.
Most common suicidal pesticide are classified according to WHO to organophosphorus insecticides, carbamate insecticide, and methyl parathion /or the herbicide paraquat.
. Aluminum phosphide(ALP) becomes one of the commonest causes of poisoning. It is extremely toxic after self-poisoning, with a case fatality often exceeding 70% after ingestion.
Severe poisoning also has the potential to induce multi-organ failure. The exact site or mechanism of its action has not been proved in humans. Rather than targeting a single organ to cause gross damage.
organophosphorus pesticides inhibit acetylcholine esterase enzyme so that lead to accumulation of Ach and muscarinic, nicotinic and central nervous system (CNS) receptor overstimulation. The severity of acute poisoning depends on level of cholinesterase.
Detection of pseudocholinestrase is a good biomarker and the most specific lab test of acute pesticide poisoning.
There is a relative relationship between plasma cholinesterase and manifestation and final outcome so that level of PChE is a good prognostic value and could help in treatment plans.
Cholinergic stimulation of pancreas leads to hyperamylasemia so amylase could be used as a prognostic tool of acute pesticide poisoning, lipase can be helpful with amylase for early detect of pancreatitis as well as determination of severity of poisoning.
The neutrophil-to-lymphocyte ratio (NLR) is an independent predictor of short- and long-term mortality in critically ill patients, and measurement is simple, cheap, and fast Furthermore, the NLR is a powerful prognostic predictor of cardiovascular affection, acute ischemic stroke, and many other diseases. So high NLR is associated with the risk of mortality of acute toxicity.
laboratory evaluation through using rapid, simple, cheap tests plays an important and vital role for confirmation of poisoning, diagnosing the first acute organ damage as well as assessing the severity of poisoning.
Emergency physicians can help in improvement of these patient and reduce deaths by accurate assessment of lab markers.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- * Sociodemographic criteria: age, gender, residence, occupation, level of education, * Toxicity associated data: mode of exposure, time of exposure, symptoms appear, any measures done to reduce the toxicity before reaching the hospital * Medical history (HR, BP, kidney function, liver function and blood glucose level) * Clinical lab result of pseudocholinesterase, amylase, lipase and neutrophil-to-lymphocyte ratio at three times. * the first with 6 hrs. of admission * the second after 24 hrs. of the treatment regimen taken * the third after 48 hrs
Key inclusion criteria (3 listed)
- All ages
- Both sex
- Any possible route of exposure to pesticides
Key exclusion criteria (5 listed)
- Exposure to medications or toxic chemicals other than pesticides.
- Patients with chronic comorbidities, including liver cirrhosis, symptomatic heart failure, end stage CKD(on regular hemodialysis) and COPD.
- Patients with gallstone history or DM
- Recent abdominal trauma
- Open abdominal surgery within one year ago
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 |
|---|---|---|
| pseudocholinestereaseAlso: lipase, NLR, amylaseblood samples | Diagnostic test | – |
Primary outcome
Diagnostic and prognostic values of cholinesterase in acute pesticide poisoning cases
Time frame: baseline
clinical lab result of pseudocholinesterase
diagnostic and prognostic value of amylase in acute pesticide poisoning cases
Time frame: baseline
blood level of amylase
diagnostic and prognostic value of lipase in acute pesticide poisoning cases
Time frame: baseline
blood level of lipase
diagnostic and prognostic value of neutrophil-to-lymphocyte ratio in acute pesticide poisoning case
Time frame: baseline
blood level of neutrophil-to-lymphocyte ratio
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2022.
- Background: PubMed 31814946Afzali S, Taheri SK, Seifrabiei M. Butyrylcholinesterase level in poisoned patients with phosphide compounds. Caspian J Intern Med. 2019 Fall;10(4):458-462. doi: 10.22088/cjim.10.4.458.
- Background: PubMed 33287770Boedeker W, Watts M, Clausing P, Marquez E. The global distribution of acute unintentional pesticide poisoning: estimations based on a systematic review. BMC Public Health. 2020 Dec 7;20(1):1875. doi: 10.1186/s12889-020-09939-0.
- Background: PubMed 34307885Mu Y, Hu B, Gao N, Pang L. Prognostic value of the neutrophil-to-lymphocyte ratio in acute organophosphorus pesticide poisoning. Open Life Sci. 2021 Jul 15;16(1):703-710. doi: 10.1515/biol-2021-0069. eCollection 2021.
- Background: PubMed 22450207Mehrpour O, Jafarzadeh M, Abdollahi M. A systematic review of aluminium phosphide poisoning. Arh Hig Rada Toksikol. 2012 Mar;63(1):61-73. doi: 10.2478/10004-1254-63-2012-2182.
- Background: PubMed 32670933Dungdung A, Kumar A, Kumar B, Preetam M, Tara RK, Saba MK. Correlation and prognostic significance of serum amylase, serum lipase, and plasma cholinesterase in acute organophosphorus poisoning. J Family Med Prim Care. 2020 Apr 30;9(4):1873-1877. doi: 10.4103/jfmpc.jfmpc_205_20. eCollection 2020 Apr.
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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 Mohammed Abd EL-Rahman, Ass.Prof study director
Assiut University
Hanan Sharaf El_Deen Mohammed, Ass.prof study director
Assiut University
Questions about this trial
What is this clinical trial studying?
An observational study of Pesticide Poisoning, run by Assiut 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 3 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: status not confirmed, as of the sponsor's last update on 4 Apr 2022. 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 Asmaa AbouBakr Ahmed Ibrahim, Demonstrator (+201095978353, asmaa.aboubakr99@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic and prognostic values of cholinesterase in acute pesticide poisoning cases (time frame: baseline). The study lists 4 primary outcomes in all. 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 NCT05310188, 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 4 Apr 2022.