Neurotoxicity Clinical Trial
Official title:
Assessment of the Prognostic Value of Nerve Damage Biomarkers in Acute and Chronic Organophosphate Toxicity
NCT number | NCT06021262 |
Other study ID # | 0107603 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | August 2023 |
Est. completion date | January 2024 |
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 1. What are the prognostic values of neuroinflammatory markers? 2. What are the genotoxic effects of organophosphates? 3. what are the changes occurring in the levels of traditional oxidative stress and inflammatory markers?
Status | Recruiting |
Enrollment | 90 |
Est. completion date | January 2024 |
Est. primary completion date | December 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Egypt | Alexandria Main University Hospital | Alexandria |
Lead Sponsor | Collaborator |
---|---|
Alexandria University |
Egypt,
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Identification of neuroinflammatory biomarker | The biomarker should correlate with nerve injury | 1.5 years | |
Primary | Identification of the mechanism of neuroinflammation | 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 |
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