Role of Steroids and Extended Scorpion Anti-Venom Use in Cardiac Affection Among Scorpion Stung Pediatric Cases

NCT ID: NCT06838715

Last Updated: 2025-02-21

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-01
• Study Completion Date: 2026-05-01

Brief Summary

Scorpion envenomation is considered a serious public health issue in the Middle East and Northern Sahara . According to the world health organization (WHO), around 1.2 to 1.5 million individuals are suspected to scorpion stings annually in Middle East; with 3000 to 5000 deaths rate .

Detailed Description

In Egypt, the percent of scorpion cases was 1.6% of all patients presented to Ain Shams University Poison Control Center during 2019.Initially within 1-2 hours of sting hypotension and bradycardia are encountered followed by hypotension and tachycardia between 4 and 48 hours due to severe left ventricular dysfunction and hypotension alone with good volume pulse and warm extremities is observed later in the recovery stage.

Cardiopulmonary problems such pulmonary edema and/or cardiogenic shock are the key characteristics of severe cases.Myocardial ischemia, release of catechol amines, and the direct impact of scorpion venom on cardiac fibers are the main three explanations to these cardiac complications.

Inflammation is one of the key processes involved in the pathogenesis. Neurotoxins can cause the release of inflammatory mediators. Increased pulmonary vascular permeability following the release of inflammatory mediators, such as platelet activating factor, leukotrienes, and prostaglandins had been suggested to explain the development of cardiogenic pulmonary edema.

Troponin is the biomarker of choice for the detection of cardiac injury. Cardiac troponin I (cTnI) isoform is predominant in myocardial tissue .Increased serum levels of pro-inflammatory cytokines, interleukins and tumor necrosis factor alpha had also been observed in many experimental studies following scorpion envenomation in plasma and in rat lungs respectively and on humans.

Scorpion Anti-Venom has a significant role in life saving of stung patients, but there is still a conflict about the duration of its administration mainly after occurrence of myocardial toxicity in stung patients. Corticosteroids are known to decrease the level of inflammatory mediators produced during the process of inflammation including cytokines. Dexamethasone is steroid with powerful anti-inflammatory effect that works by calming down body's immune response to reduce pain, itching and swelling .

Conditions

Scorpion Envenomation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Group of non extended anti-venom:

About 20 Patients treated with classical non extended anti-venom regimen as 3-5 ampoules by injection and supportive measure only with evaluation of cytokine 6 hours, 24 hours and 72 hours or relief of symptoms after the sting.

Group Type: ACTIVE_COMPARATOR

Dexamethasone

Intervention Type: DRUG

Assessing the relation between the level of cytokines (interleukins and tumor necrosis factor alpha) and the development of cardiac complications associated with scorpion envenomation among pediatric patients. and Evaluating the role of the use of Dexamethasone and/or extended anti-venom administration on cardiac function and outcome in pediatric cases.

Group of Dexamethazone

About 20 Patients treated with Dexamethazone (The dose as: 0.2 mg/kg/day in week1, 0.15 mg/kg/day in week 2, 0.075 mg/kg/day in week) besides supportive measures with evaluation of cytokine 6 hours, 24 hours and 72 hours or relief of symptoms after the sting.

Group Type: ACTIVE_COMPARATOR

Dexamethasone

Intervention Type: DRUG

Assessing the relation between the level of cytokines (interleukins and tumor necrosis factor alpha) and the development of cardiac complications associated with scorpion envenomation among pediatric patients. and Evaluating the role of the use of Dexamethasone and/or extended anti-venom administration on cardiac function and outcome in pediatric cases.

Group of extended antivenom regimen

About 20 Patients treated with extended antivenom regimen as 3-5 ampoules by injection besides supportive measures with evaluation of cytokine 6 hours, 24 hours and 72 hours or relief of symptoms after the sting.

Group Type: ACTIVE_COMPARATOR

Dexamethasone

Intervention Type: DRUG

Assessing the relation between the level of cytokines (interleukins and tumor necrosis factor alpha) and the development of cardiac complications associated with scorpion envenomation among pediatric patients. and Evaluating the role of the use of Dexamethasone and/or extended anti-venom administration on cardiac function and outcome in pediatric cases.

Group of Dexamethazone and extended antivenom regimen

About 20 Patients treated with Dexamethazone (The dose as: 0.2 mg/kg/day in week1, 0.15 mg/kg/day in week 2, 0.075 mg/kg/day in week) and extended antivenom regimen as 3-5 ampoules by injection besides supportive measures with evaluation of cytokine evaluation of cytokine 6 hours, 24 hours and 72 hours or relief of symptoms after the sting.

Group Type: ACTIVE_COMPARATOR

Dexamethasone

Intervention Type: DRUG

Assessing the relation between the level of cytokines (interleukins and tumor necrosis factor alpha) and the development of cardiac complications associated with scorpion envenomation among pediatric patients. and Evaluating the role of the use of Dexamethasone and/or extended anti-venom administration on cardiac function and outcome in pediatric cases.

Interventions

Dexamethasone

Assessing the relation between the level of cytokines (interleukins and tumor necrosis factor alpha) and the development of cardiac complications associated with scorpion envenomation among pediatric patients. and Evaluating the role of the use of Dexamethasone and/or extended anti-venom administration on cardiac function and outcome in pediatric cases.

Intervention Type: DRUG

Other Intervention Names

Scorpion Anti Venom

Eligibility Criteria

Inclusion Criteria

• Patients with scorpion stings and diagnosed as grade 1, 2 & 3 (according to recent history of scorpion sting and clinical presentation at the time of admission) .

Exclusion Criteria

• Patients with history of cardiac disease, OR previous cardiac operation and or previous abnormal cardiac investigations .
• Patients with history of chronic renal, hepatic, chest or CNS diseases .
• Patients with chronic inflammatory diseases such as auto-immune diseases, with chronic use of corticosteroids .
• Envenomated cases that are described as grade 4 scorpion envenomation.
• Cases of scorpion sting above age of 18 years.

• Minimum Eligible Age: 1 Day
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Yousef Ahmed Yousef Hasan

Lecturer of Pediatrics

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Marwa Khalifa Mohamed, lecturer

Role: STUDY_DIRECTOR

Assiut University

Nagwa Mahmoud Ali, professor

Role: STUDY_CHAIR

Assiut University

Hala Mohamed Fathi, professor

Role: STUDY_CHAIR

Assiut University

Locations

Assiut University Pediatric Hospital

Asyut, , Egypt

Countries

Egypt

Central Contacts

yousef Ahmed Yousef, M.D

Role: CONTACT

youssif_hassan@med.aun.edu.eg

01020098463

Facility Contacts

Zeinab Al- Badry Mohammed, Lecturer

Role: primary

Zeinab_albadry@aun.edu.eg

01095653919

Marwa Khalifa Mohamed, Lecturer

Role: backup

marwakhalifa@aun.edu.eg

01004514945

References

Abroug F, Ouanes-Besbes L, Tilouche N, Elatrous S. Scorpion envenomation: state of the art. Intensive Care Med. 2020 Mar;46(3):401-410. doi: 10.1007/s00134-020-05924-8. Epub 2020 Mar 3.

Reference Type: RESULT

PMID: 32125457 (View on PubMed)

Other Identifiers

Scorpion in Pediatrics

Identifier Type: -

Identifier Source: org_study_id