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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 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.

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06108557
Enrollment
90
Registered
2023-10-31
Start date
2024-01-31
Completion date
2025-08-31
Last updated
2023-10-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Organophosphate Poisoning

Brief 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 . 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).

Interventions

DIAGNOSTIC_TESTSerum Pararoxonase -1 level

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_TESTDiagnostic Test: Serum pseudocholinesterase enzyme level

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.

Sponsors

Sohag University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
7 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

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.

Exclusion criteria

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).

Design outcomes

Primary

MeasureTime frameDescription
Evaluate the serum Paraoxonase-1 level18 monthsEvaluate 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.

Secondary

MeasureTime frameDescription
Evaluate Serum pseudocholinesterase level18 monthsEvaluate 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.

Contacts

Primary Contactalaa M abd elgwad, assistant lecutrer
alaa_mohamed@med.edu.eg01095929540

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026