NCT06108557

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2024

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 25, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 31, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

January 1, 2024

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2025

Completed
Last Updated

October 31, 2023

Status Verified

October 1, 2023

Enrollment Period

1.5 years

First QC Date

October 25, 2023

Last Update Submit

October 25, 2023

Conditions

Organophosphate Poisoning

Outcome Measures

Primary Outcomes (1)

  • 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.

    18 months

Secondary Outcomes (1)

  • Evaluate Serum pseudocholinesterase level

    18 months

Study Arms (2)

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.

Diagnostic Test: Serum Pararoxonase -1 levelDiagnostic 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 .

Diagnostic Test: Serum Pararoxonase -1 levelDiagnostic Test: Diagnostic Test: Serum pseudocholinesterase enzyme level

Interventions

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.

case groupcontrol group
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.

case groupcontrol group

Eligibility Criteria

Age7 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • 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.

    PMID: 17936934BACKGROUND

  • Josse 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.

    PMID: 11920913BACKGROUND

  • Kim 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.

    PMID: 35127097BACKGROUND

  • La Du BN. Structural and functional diversity of paraoxonases. Nat Med. 1996 Nov;2(11):1186-7. doi: 10.1038/nm1196-1186. No abstract available.

    PMID: 8898738BACKGROUND

MeSH Terms

Conditions

Organophosphate Poisoning

Condition Hierarchy (Ancestors)

PoisoningChemically-Induced Disorders

Central Study Contacts

alaa M abd elgwad, assistant lecutrer

CONTACT

01095929540alaa_mohamed@med.edu.eg

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant lecturer

Study Record Dates

First Submitted

October 25, 2023

First Posted

October 31, 2023

Study Start

January 1, 2024

Primary Completion

July 1, 2025

Study Completion

August 1, 2025

Last Updated

October 31, 2023

Record last verified: 2023-10