Clinical trial NCT06838715: Role of Steroids and Extended Scorpion Anti-Venom Use in Cardiac Affection Among Scorpion Stung Pediatric Cases
Official title: Role of Steroids and Extended Scorpion Anti-Venom Use in Cardiac Affection Among Scorpion Stung Pediatric Cases
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Scorpion Envenomation
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2025-02-21
Enrollment: 80
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 .

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.

Primary outcomes:
measure: Safety and Tolerability of steroids and anti-venom regimen
timeFrame: 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut University Pediatric Hospital
Study officials:
affiliation: Assiut University
name: Marwa Khalifa Mohamed, lecturer
role: STUDY_DIRECTOR
affiliation: Assiut University
name: Nagwa Mahmoud Ali, professor
role: STUDY_CHAIR
affiliation: Assiut University
name: Hala Mohamed Fathi, professor
role: STUDY_CHAIR
References:
citation: 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.