Assessment of Nerve Damage Biomarkers in Acute and Chronic Organophosphate Toxicity
August 27, 2023 updated by: Ahmed El-Yazbi, Alexandria University
Assessment of the Prognostic Value of Nerve Damage Biomarkers in Acute and Chronic Organophosphate Toxicity
The aim of this observational study is to answer the following questions in individuals with acute and chronic exposure to organophosphates. The main questions to be addressed are
- What are the prognostic values of neuroinflammatory markers?
- What are the genotoxic effects of organophosphates?
- what are the changes occurring in the levels of traditional oxidative stress and inflammatory markers?
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
This is a cross-sectional study that aims to assess the possible prognostic value of markers of neuroinflammation and nerve damage in patients with acute and chronic exposure to organophosphate pesticides by conducting a full proteomic and metabolomic profile.
The possible genotoxic effect of common organophosphate pesticides will be studied as well.
This will be conducted in parallel to the assessment of traditional markers of inflammation and oxidative stress.
The target populations are patients with acute and chronic exposure to organophosphates with a total estimated number of 90 including individuals assigned to the control group with matched age and gender.
Study Type
Observational
Enrollment (Estimated)
90
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Ahmed F. El Yazbi, professor
- Phone Number: 002 01155881772
- Email: Ayazbi@aiu.edu.eg
Study Contact Backup
- Name: Dina M. El-Gameel, Bachelor of Clinical Pharmacy
- Phone Number: 002 01157018176
- Email: s-dina.elgameel@alexu.edu.eg
Study Locations
-
-
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Alexandria, Egypt
- Recruiting
- Alexandria main university hospital
-
Contact:
- Maha A. Ghanem, professor
- Phone Number: 002 01223374415
- Email: ghanemmaha63@gmail.com
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Sampling Method
Non-Probability Sample
Study Population
- Acute exposure patients will be recruited from the Poison Center and Emergency Department of Alexandria Main University Hospital.
- Chronic exposure patients will be recruited from farm field workers with a confirmed history of repeated occupational exposure to organophosphate pesticides.
- Control subjects will be recruited from city dwellers without any medical conditions (healthy subjects) with comparable age and gender.
Description
Inclusion Criteria:
- For the control group: healthy individuals without previous exposure to organophosphates, with the specified age limits.
- For the acute exposure group: patients with acute exposure to organophosphates, with the specified age limits
- For the chronic exposure group: patients with chronic exposure to organophosphates, with the specified age limits
No restrictions on comorbidities in the three groups except those mentioned under Exclusion Criteria
Exclusion Criteria:
- Pediatric patients.
- Patients with neurological diseases (Parkinsonism, epilepsy, Alzheimer's disease, etc.)
- Patients who does not meet the inclusion criteria.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
control group
healthy individuals without previous acute or chronic exposure to organophosphates
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|
|
chronic exposure group
patients with chronic occupational or environmental exposure to organophosphates
|
organophosphates are esters of phosphoric acids or Thio phosphoric acids that exist in pesticides, where patients can be chronically or acutely exposed to such compounds.
|
|
acute exposure group
patients with acute exposure to organophosphates in accidental or suicidal settings
|
organophosphates are esters of phosphoric acids or Thio phosphoric acids that exist in pesticides, where patients can be chronically or acutely exposed to such compounds.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Identification of neuroinflammatory biomarker
Time Frame: 1.5 years
|
The biomarker should correlate with nerve injury
|
1.5 years
|
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Identification of the mechanism of neuroinflammation
Time Frame: 1.5 years
|
To detect the possible pathways involved in initiation of systemic inflammation rather than inhibition of choline esterase enzyme.
As well as, studying the possible relation of these identified mechanisms with neuronal inflammation and damage.
|
1.5 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Syed S, Gurcoo SA, Farooqui AK, Nisa W, Sofi K, Wani TM. Is the World Health Organization-recommended dose of pralidoxime effective in the treatment of organophosphorus poisoning? A randomized, double-blinded and placebo-controlled trial. Saudi J Anaesth. 2015 Jan;9(1):49-54. doi: 10.4103/1658-354X.146306.
- Tallat S, Hussien R, Mohamed RH, Abd El Wahab MB, Mahmoud M. Caspases as prognostic markers and mortality predictors in acute organophosphorus poisoning. J Genet Eng Biotechnol. 2020 Apr 13;18(1):10. doi: 10.1186/s43141-020-00024-y.
- Rahimi R, Nikfar S, Abdollahi M. Increased morbidity and mortality in acute human organophosphate-poisoned patients treated by oximes: a meta-analysis of clinical trials. Hum Exp Toxicol. 2006 Mar;25(3):157-62. doi: 10.1191/0960327106ht602oa.
- Caba IC, Streanga V, Dobrin ME, Jitareanu C, Jitareanu A, Profire BS, Apotrosoaei M, Focsa AV, Caba B, Agoroaei L. Clinical Assessment of Acute Organophosphorus Pesticide Poisoning in Pediatric Patients Admitted to the Toxicology Emergency Department. Toxics. 2022 Oct 2;10(10):582. doi: 10.3390/toxics10100582.
- Naughton SX, Terry AV Jr. Neurotoxicity in acute and repeated organophosphate exposure. Toxicology. 2018 Sep 1;408:101-112. doi: 10.1016/j.tox.2018.08.011. Epub 2018 Aug 23.
- Lionetto MG, Caricato R, Calisi A, Giordano ME, Schettino T. Acetylcholinesterase as a biomarker in environmental and occupational medicine: new insights and future perspectives. Biomed Res Int. 2013;2013:321213. doi: 10.1155/2013/321213. Epub 2013 Jul 11.
- Therkorn J, Drewry DG, Tiburzi O, Astatke M, Young C, Rainwater-Lovett K. Review of Biomarkers and Analytical Methods for Organophosphate Pesticides and Applicability to Nerve Agents. Mil Med. 2020 Mar 2;185(3-4):e414-e421. doi: 10.1093/milmed/usz441.
- Kobeissy F, Kobaisi A, Peng W, Barsa C, Goli M, Sibahi A, El Hayek S, Abdelhady S, Ali Haidar M, Sabra M, Oresic M, Logroscino G, Mondello S, Eid AH, Mechref Y. Glycomic and Glycoproteomic Techniques in Neurodegenerative Disorders and Neurotrauma: Towards Personalized Markers. Cells. 2022 Feb 8;11(3):581. doi: 10.3390/cells11030581.
- Salvi RM, Lara DR, Ghisolfi ES, Portela LV, Dias RD, Souza DO. Neuropsychiatric evaluation in subjects chronically exposed to organophosphate pesticides. Toxicol Sci. 2003 Apr;72(2):267-71. doi: 10.1093/toxsci/kfg034.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
August 1, 2023
Primary Completion (Estimated)
December 1, 2023
Study Completion (Estimated)
January 1, 2024
Study Registration Dates
First Submitted
August 27, 2023
First Submitted That Met QC Criteria
August 27, 2023
First Posted (Actual)
September 1, 2023
Study Record Updates
Last Update Posted (Actual)
September 1, 2023
Last Update Submitted That Met QC Criteria
August 27, 2023
Last Verified
August 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0107603
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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