Clinical trial NCT06703645: Evaluation of Snakebite Cases in Assiut Governorate, Egypt (Prospective Study)
Official title: Evaluation of Snakebite Cases in Assiut Governorate, Egypt (Prospective Study)
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Snakebite Cases Evaluation Clinical and Laboratory
Keywords: snakebite
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2024-11-25
Enrollment: 49
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Cases will be collected from emergency departments, inpatient units of Assiut University Hospitals, El Eman General Hospital and Assiut General Hospital. All cases will be evaluated by detailed history, examination, investigations and through sheet which consist of:

1. Detailed information regarding demographic and epidemiological parameters such as age, sex, residence, occupation, site, time and place of bite in addition to type of snake if identification was obtained.
2. Clinical manifestations:

   * Local manifestations
   * Systemic manifestations

     * Hematological e.g., spontaneous bleeding like epistaxis, hematemesis, melena, and hematuria.
     * Neurological e.g., ptosis, dysphonia, dysphagia, and descending paralysis.
     * Cardiovascular e.g., dizziness, palpitation, faintness, hypotension, cardiac arrhythmias, and shock.
     * Respiratory e.g., tachypnea and shortness of breathing
   * The severity of envenomation will be assessed using the scoring and grading systems

Brief summary: 1. Study the sociodemographic profile of snakebite victims in Assiut Governorate.
2. Portray the clinical profile of snakebite victims admitted to Assiut University , El Eman General Hospital and Assiut General Hospital.
3. Assess the predictors of severity and outcome of cases.

Detailed description: Snake's envenomation is a serious socio-medical problem, which causes considerable mortality and morbidity, with approximately 125,000 deaths worldwide annually. There were 4.5 to 5.4 million bites every year, and of those figures, 40-50% had some clinical disability as a result. Furthermore, the death from such an issue could go somewhere between 80,000 and 130,000 individuals each year. In the Middle East and North Africa, there are over 70,000 snakebites bites each year.

There are many species of snakes, approximately 3,700 species of snakes worldwide only about 15% are venomous belong to the four large families including Viperidae, Colubridae, Elapidae and Atractaspidinae. Two of these toxic species are widespread in Egypt; the family Viperidae and the family Elapidae Egyptian copra Naja Haje.

Snake venoms are complex mixtures consisting of enzymatic components e.g., proteolytic enzymes e.g., serine protease and metalloproteases (SVMPs), non-enzymatic components e.g., cysteine-rich secretory proteins (CRISP), amines, lipids, nucleotides, and carbohydrates. Venoms also contain inorganic cations that are presumed to function as cofactors and include sodium, calcium, potassium, magnesium, and zinc.

Snake venoms are usually classified as hemotoxic or neurotoxic. Snakes of the Viperidae family have venom containing proteins that can disrupt the coagulation cascade, the hemostatic system and tissue integrity. In contrast, neurotoxic venoms, which are typical of the Elapidae snakes, contain several toxins that primarily affect the peripheral nervous system, in particular the neuromuscular junction.

Depending on the species of snakes, manifestations can be localized symptoms of mild pain, progressive edema, ecchymosis, and tissue necrosis and generalized ones as spontaneous bleeding e.g., bleeding per gums, epistaxis, hematuria, vaginal bleeding, hematemesis, hematochezia, hemoptysis, hemolytic anemia and hemolytic jaundice with hemototoxic snake venom. In severe cases patients may develop acute renal, myocardial infarction, disseminated intravascular coagulation, or even death. Ptosis, diplopia, dysphagia, trunk and limbs weakness, and respiratory paralysis which can lead to respiratory failure and apnea with neurotoxic snake venom.

Eligibility criteria: Inclusion Criteria:

* Patients admitted with a reliable history of snakebite.
* Presence of fang marks and/or signs of local and systemic envenomation.

Exclusion Criteria:

* Fake or uncertain snakebites.
* Patients with history of hematological disorders, liver diseases, renal diseases and anticoagulation therapy in the past week.
* Patients who are not willing to participate in the study.

Primary outcomes:
measure: Number of Participants with recovery
timeFrame: through study completion, an average of 1 year".
measure: Number of Participants with Death
timeFrame: through study completion, an average of 1 year".
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Assiut University
name: Hala Mohammed Fathy, Professor
role: STUDY_DIRECTOR
affiliation: Assiut University
name: Nora Zeidan Abdellah, Assistant lecture
role: STUDY_DIRECTOR
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