Organophosphate PoisoningNCT06108557
Paraoxonase-1 Pseudo Cholinesterase Organophosphate Toxicity Enzyme in Prediction the Severity and Outcome of Acute Organophosphate Poisoning and Its Correlation With Pseudo Cholinesterase Enzyme Level.
A study testing Serum Pararoxonase -1 level and Diagnostic Test: Serum pseudocholinesterase enzyme level in people with Organophosphate Poisoning, run by Sohag University.
Trial summary
The aim of the present study is to: Evaluate the serum Paraoxonase-1 level in cases with organophosphate compounds poisoning and to correlate it᾿s level with the severity, outcome of acutely organophosphate poisoned cases . Read more about this study
- Who is it for?
- Ages 7 years and olderHealthy volunteers can take part
- Conditions the study is for
- Organophosphate Poisoning
- What is being tested?
- Serum Pararoxonase -1 level and Diagnostic Test: Serum pseudocholinesterase enzyme level
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- Jan 2024to Aug 2025
- 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 7 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- According to Patil (2014)'s recommendations, the following criteria are used to make the diagnosis of OPC poisoning:
- Previous OPC exposure. The cholinergic toxidrome-specific features of OPC toxicity. After using atropine, muscarinic symptoms and signs improved. low pseudo-cholinesterase activity in serum.
Who cannot join
- Cases under the age of 7. Asymptomatic cases. cases who have a history of severe renal, cardiac, pulmonary, or nephritic syndrome.
- cases with any of the following conditions which reduce pseudocholinesterase activity: cases who have a history of parenchymal liver disease, acute infection, metastatic cancer, malnutrition, iron deficiency anemia, or dermatomyositis.
- cases who are pregnant or who are using narcotics or poisonous substances (such as cocaine, carbon disulfide, benzalkonium salts, organic mercury compounds, ciguatoxins, and solanines) (oral contraceptive pills and metoclopramide).
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Prospective Study on the Role of Paraoxonase-1 Enzyme in Prediction the Severity and Outcome of Acute Organophosphate Poisoning and Its Correlation With Pseudo Cholinesterase Enzyme Level.
The aim of the present study is to:
Evaluate the serum Paraoxonase-1 level in cases with organophosphate compounds poisoning and to correlate it᾿s level with the severity, outcome of acutely organophosphate poisoned cases .
Evaluate the serum pseudocholinestrase level in cases with organophosphate compounds poisoning and to correlate it with the Paraoxonase-1 level in those cases.
Read the detailed description
Pesticides refer to a wide range of chemicals that are employed to increase agricultural output. Several pesticides have been shown to have severe negative impacts on human health, including acute toxicity (accidental poisoning deaths, particularly in impoverished nations) and chronic toxicity (even at low concentrations) (Trellu et al., 2021).
In the central nervous system of mammals and insects, organophosphate compounds (OPC) inhibit acetylcholinesterase irreversibly by inhibiting acetylcholine breakdown during nerve impulse transmission. Continuous neuronal excitation causes a variety of hazardous symptoms, including slow heart rate, pinpoint pupils, and seizures and respiratory failure (RF) which is the leading cause of morbidity and fatality (Zhai et al., 2021).
The diagnosis of acute organophosphate poisoning is based on the individual's medical history, physical examinations, and toxidromes of acute poisoning. Predicting the severity, prognosis, and complications related to poisoning requires a variety of clinical observations, electrocardiography, and blood or urine sample results. Electrolytes, the complete blood count, and arterial blood gas are virtually always tested (Kim et al., 2022).
Research started to focus on Paraoxonase-1 enzyme after terrorists released sarin in a Tokyo subway in 1995, which resulted in several deaths (La Du, 1996 ). Scientists searched for a potent enzyme for the rapid clearance of nerve agents (Josse et al., 2001).
Paraoxonase-1 (PON1) is an esterase that protects low-density lipoproteins from oxidation and detoxifies organophosphates and nerve agents. Paraoxonase-1 is predominantly produced in the liver, although enzyme activity has been detected in the kidney and brain (Schomaker et al., 2013).
They are found in a variety of tissues and are mostly linked to cell membranes and certain lipoproteins, while a free enzyme has been discovered in the blood (Reichert et al., 2021).
Initial baseline data suggests that Paraoxonase-1 varies among healthy people. Paraoxonase-1 exhibits broad range of specificity, affinity and different rates of hydrolysis for organophosphate compounds (Li et al., 2000).
Levels of plasma Paraoxonase-1 can vary tremendously, due to the polymorphisms in the promoter region of Paraoxonase-1 gene (Furlong, 2007).
Human serum Paraoxonase-1 hydrolyzes organophosphate compounds and so may significantly alters an individual᾿s susceptibility to the toxicity of these chemicals (Richard et al., 2013).
- Conditions
- Organophosphate Poisoning
- Being tested
- Serum Pararoxonase -1 level, Diagnostic Test: Serum pseudocholinesterase enzyme level
- Medical subject headings
- Organophosphate Poisoning
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Serum Pararoxonase -1 levelDiagnostic test
The individual's venous blood will be taken five milliliters under strict aseptic conditions of both control and case groups (before antidotal therapy). Then the blood will be left to be coagulated for 10-20 minutes at room temperature, then centrifugation will be done by laboratory centrifuge. Serum samples were obtained, then half of the separated serum will be used for pseudocholinesterase enzyme assay and the other one will be used for Paraoxanase-1 (PON-1) analysis .
Serum PON-1: The enzyme-linked immunosorbent assay (ELISA) will be used to measure it using human Pararoxonase (PON) ELISA kits.
Serum pseudocholinesterase: is based on spectrophotometric measurement.
Diagnostic Test: Serum pseudocholinesterase enzyme levelDiagnostic test
The individual's venous blood will be taken five milliliters under strict aseptic conditions of both control and case groups (before antidotal therapy). Then the blood will be left to be coagulated for 10-20 minutes at room temperature, then centrifugation will be done by laboratory centrifuge. Serum samples were obtained, then half of the separated serum will be used for pseudocholinesterase enzyme assay and the other one will be used for Paraoxanase-1 (PON-1) analysis .
Serum PON-1: The enzyme-linked immunosorbent assay (ELISA) will be used to measure it using human Pararoxonase (PON) ELISA kits.
Serum pseudocholinesterase: is based on spectrophotometric measurement.
| Study group | Role | What they receive |
|---|---|---|
| control group | Active comparator | Group I (Control group): which will include 20 healthy volunteers who will be selected based on their clinical examination, recent clinical history, and age and sex matching to the case group.This control group will be the basic profile for the studied group. Receives: Diagnostic Test: Serum Pararoxonase -1 level; Diagnostic Test: Diagnostic Test: Serum pseudocholinesterase enzyme level |
| case group | Active comparator | Group II (Case group): which will include 70 cases, including both genders who will be admitted to Sohag University Hospital with acute organophosphate poisoning . Receives: Diagnostic Test: Serum Pararoxonase -1 level; Diagnostic Test: Diagnostic Test: Serum pseudocholinesterase enzyme level |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the serum Paraoxonase-1 level
Evaluate the serum Paraoxonase-1 level in cases with organophosphate compounds poisoning and to correlate it᾿s level with the severity, outcome of acutely organophosphate poisoned cases .
the individual's venous blood will be taken five milliliters under strict aseptic conditions of both control and case groups (before antidotal therapy). Then the blood will be left to be coagulated for 10-20 minutes at room temperature, then centrifugation will be done by laboratory centrifuge. Serum samples were obtained, then half of the separated serum will be used for pseudocholinesterase enzyme assay and the other one will be used for Paraoxanase-1 (PON-1) analysis .
Serum PON-1: The enzyme-linked immunosorbent assay (ELISA) will be used to measure it using human Pararoxonase (PON) ELISA kits.
Measured: 18 months
Secondary outcomes (1)
Evaluate Serum pseudocholinesterase level
Evaluate the serum pseudocholinestrase level in cases with organophosphate compounds poisoning and to correlate it with the Paraoxonase-1 level in those cases.
Serum pseudocholinesterase: is based on spectrophotometric measurement.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2023
- Study startJan 2024 (estimated)
- Primary completionJul 2025 (estimated)
- Study completionAug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Organophosphate PoisoningStudies 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alaa Mohamed Abdelgawad, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06108557
- Sponsor's protocol ID
- Soh-Med-23-10-14MD
- Status last verified
- Oct 2023
- First submitted
- 25 Oct 2023
- Last updated
- 31 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Furlong CE. Genetic variability in the cytochrome P450-paraoxonase 1 (PON1) pathway for detoxication of organophosphorus compounds. J Biochem Mol Toxicol. 2007;21(4):197-205. doi: 10.1002/jbt.20181.
PubMed 17936934Josse D, Lockridge O, Xie W, Bartels CF, Schopfer LM, Masson P. The active site of human paraoxonase (PON1). J Appl Toxicol. 2001 Dec;21 Suppl 1:S7-11. doi: 10.1002/jat.789.
PubMed 11920913Kim YO, Kim HI, Jung BK. Pattern of change of C-reactive protein levels and its clinical implication in patients with acute poisoning. SAGE Open Med. 2022 Jan 30;10:20503121211073227. doi: 10.1177/20503121211073227. eCollection 2022.
PubMed 35127097La Du BN. Structural and functional diversity of paraoxonases. Nat Med. 1996 Nov;2(11):1186-7. doi: 10.1038/nm1196-1186. No abstract available.
PubMed 8898738
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study on the Role of Paraoxonase-1 Enzyme in Prediction the Severity and Outcome of Acute Organophosphate Poisoning and Its Correlation With Pseudo Cholinesterase Enzyme Level.
- ClinicalTrials.gov ID
- NCT06108557
- Acronym / sponsor ID
- Soh-Med-23-10-14MD
- Conditions
- Organophosphate Poisoning
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- Jan 2024 (estimated)
- Primary completion
- Jul 2025 (estimated)
- Study completion
- Aug 2025 (estimated)
- First posted
- 31 Oct 2023 (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 serum Paraoxonase-1 level in cases with organophosphate compounds poisoning and to correlate it᾿s level with the severity, outcome of acutely organophosphate poisoned cases .
Evaluate the serum pseudocholinestrase level in cases with organophosphate compounds poisoning and to correlate it with the Paraoxonase-1 level in those cases.
Detailed description
Pesticides refer to a wide range of chemicals that are employed to increase agricultural output. Several pesticides have been shown to have severe negative impacts on human health, including acute toxicity (accidental poisoning deaths, particularly in impoverished nations) and chronic toxicity (even at low concentrations) (Trellu et al., 2021).
In the central nervous system of mammals and insects, organophosphate compounds (OPC) inhibit acetylcholinesterase irreversibly by inhibiting acetylcholine breakdown during nerve impulse transmission. Continuous neuronal excitation causes a variety of hazardous symptoms, including slow heart rate, pinpoint pupils, and seizures and respiratory failure (RF) which is the leading cause of morbidity and fatality (Zhai et al., 2021).
The diagnosis of acute organophosphate poisoning is based on the individual's medical history, physical examinations, and toxidromes of acute poisoning. Predicting the severity, prognosis, and complications related to poisoning requires a variety of clinical observations, electrocardiography, and blood or urine sample results. Electrolytes, the complete blood count, and arterial blood gas are virtually always tested (Kim et al., 2022).
Research started to focus on Paraoxonase-1 enzyme after terrorists released sarin in a Tokyo subway in 1995, which resulted in several deaths (La Du, 1996 ). Scientists searched for a potent enzyme for the rapid clearance of nerve agents (Josse et al., 2001).
Paraoxonase-1 (PON1) is an esterase that protects low-density lipoproteins from oxidation and detoxifies organophosphates and nerve agents. Paraoxonase-1 is predominantly produced in the liver, although enzyme activity has been detected in the kidney and brain (Schomaker et al., 2013).
They are found in a variety of tissues and are mostly linked to cell membranes and certain lipoproteins, while a free enzyme has been discovered in the blood (Reichert et al., 2021).
Initial baseline data suggests that Paraoxonase-1 varies among healthy people. Paraoxonase-1 exhibits broad range of specificity, affinity and different rates of hydrolysis for organophosphate compounds (Li et al., 2000).
Levels of plasma Paraoxonase-1 can vary tremendously, due to the polymorphisms in the promoter region of Paraoxonase-1 gene (Furlong, 2007).
Human serum Paraoxonase-1 hydrolyzes organophosphate compounds and so may significantly alters an individual᾿s susceptibility to the toxicity of these chemicals (Richard et al., 2013).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | Active comparator | Diagnostic Test: Serum Pararoxonase -1 level, Diagnostic Test: Diagnostic Test: Serum pseudocholinesterase enzyme levelGroup I (Control group): which will include 20 healthy volunteers who will be selected based on their clinical examination, recent clinical history, and age and sex matching to the case group.This control group will be the basic profile for the studied group. |
| case group | Active comparator | Diagnostic Test: Serum Pararoxonase -1 level, Diagnostic Test: Diagnostic Test: Serum pseudocholinesterase enzyme levelGroup II (Case group): which will include 70 cases, including both genders who will be admitted to Sohag University Hospital with acute organophosphate poisoning . |
Who may qualify
- Ages
- 7 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- According to Patil (2014)'s recommendations, the following criteria are used to make the diagnosis of OPC poisoning:
- Previous OPC exposure. The cholinergic toxidrome-specific features of OPC toxicity. After using atropine, muscarinic symptoms and signs improved. low pseudo-cholinesterase activity in serum.
Key exclusion criteria (3 listed)
- Cases under the age of 7. Asymptomatic cases. cases who have a history of severe renal, cardiac, pulmonary, or nephritic syndrome.
- cases with any of the following conditions which reduce pseudocholinesterase activity: cases who have a history of parenchymal liver disease, acute infection, metastatic cancer, malnutrition, iron deficiency anemia, or dermatomyositis.
- cases who are pregnant or who are using narcotics or poisonous substances (such as cocaine, carbon disulfide, benzalkonium salts, organic mercury compounds, ciguatoxins, and solanines) (oral contraceptive pills and metoclopramide).
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 |
|---|---|---|
| Serum Pararoxonase -1 levelThe individual's venous blood will be taken five milliliters under strict aseptic conditions of both control and case groups (before antidotal therapy). Then the blood will be left to be coagulated for 10-20 minutes at room temperature, then centrifugation will be done by laboratory centrifuge. Serum samples were obtained, then half of the separated serum will be used for pseudocholinesterase enzyme assay and the other one will be used for Paraoxanase-1 (PON-1) analysis . Serum PON-1: The enzyme-linked immunosorbent assay (ELISA) will be used to measure it using human Pararoxonase (PON) ELISA kits. Serum pseudocholinesterase: is based on spectrophotometric measurement. | Diagnostic test | case group, control group |
| Diagnostic Test: Serum pseudocholinesterase enzyme levelThe individual's venous blood will be taken five milliliters under strict aseptic conditions of both control and case groups (before antidotal therapy). Then the blood will be left to be coagulated for 10-20 minutes at room temperature, then centrifugation will be done by laboratory centrifuge. Serum samples were obtained, then half of the separated serum will be used for pseudocholinesterase enzyme assay and the other one will be used for Paraoxanase-1 (PON-1) analysis . Serum PON-1: The enzyme-linked immunosorbent assay (ELISA) will be used to measure it using human Pararoxonase (PON) ELISA kits. Serum pseudocholinesterase: is based on spectrophotometric measurement. | Diagnostic test | case group, control group |
Primary outcome
Evaluate the serum Paraoxonase-1 level
Time frame: 18 months
Evaluate the serum Paraoxonase-1 level in cases with organophosphate compounds poisoning and to correlate it᾿s level with the severity, outcome of acutely organophosphate poisoned cases . the individual's venous blood will be taken five milliliters under strict aseptic conditions of both control and case groups (before antidotal therapy). Then the blood will be left to be coagulated for 10-20 minutes at room temperature, then centrifugation will be done by laboratory centrifuge. Serum samples were obtained, then half of the separated serum will be used for pseudocholinesterase enzyme assay and the other one will be used for Paraoxanase-1 (PON-1) analysis . Serum PON-1: The enzyme-linked immunosorbent assay (ELISA) will be used to measure it using human Pararoxonase (PON) ELISA kits.
1 secondary outcome
Evaluate Serum pseudocholinesterase level
Time frame: 18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2023.
- Background: PubMed 17936934Furlong CE. Genetic variability in the cytochrome P450-paraoxonase 1 (PON1) pathway for detoxication of organophosphorus compounds. J Biochem Mol Toxicol. 2007;21(4):197-205. doi: 10.1002/jbt.20181.
- Background: PubMed 11920913Josse D, Lockridge O, Xie W, Bartels CF, Schopfer LM, Masson P. The active site of human paraoxonase (PON1). J Appl Toxicol. 2001 Dec;21 Suppl 1:S7-11. doi: 10.1002/jat.789.
- Background: PubMed 35127097Kim YO, Kim HI, Jung BK. Pattern of change of C-reactive protein levels and its clinical implication in patients with acute poisoning. SAGE Open Med. 2022 Jan 30;10:20503121211073227. doi: 10.1177/20503121211073227. eCollection 2022.
- Background: PubMed 8898738La Du BN. Structural and functional diversity of paraoxonases. Nat Med. 1996 Nov;2(11):1186-7. doi: 10.1038/nm1196-1186. No abstract available.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Serum Pararoxonase -1 level and Diagnostic Test: Serum pseudocholinesterase enzyme level in people with Organophosphate Poisoning, run by Sohag 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 31 Oct 2023. 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 alaa M abd elgwad, assistant lecutrer (01095929540, alaa_mohamed@med.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the serum Paraoxonase-1 level (time frame: 18 months). 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 NCT06108557, which also lists 4 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 31 Oct 2023.