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NCT Number: NCT05954806

Clinical Profile and Antivenom Use in Hump-nosed Pit Viper Bites in Kerala, South India: A Review.

Several controversies exist in Hypnale bite management in Kerala. Even though leading bodies like WHO recommend against using antivenom for hypnale bites, many physicians still administer antivenom for snakebites even when the culprit snake is identified. Anecdotal experience suggests that the reasons for doing so range from lack of confidence in the identification of the snake, confusion as to whether or not to approach it syndromically and symptomatically rather than relying on the species identification, doubts as to whether there exists para-specific neutralization capability for the available polyvalent antivenom and fear of medicolegal culpability in denying antivenom in a case of 'snake envenomation'. To date, these domains and rationale have not been studied. It is also to be kept in mind that the evidence behind the WHO recommendation against the use of antivenom in Hypnale is based on expert opinion and case reports. The investigators intend to compare clinical manifestation and outcome amongst Hypnale hypnale bite patients who received the polyvalent antivenom to those who did not.

The investigators also intend to describe the clinical and laboratorical profile of patients with Hypnale hypnale envenomation .

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Key information

Conditions

Envenomation, Snakebite Bites and Stings Chemically-Induced Disorders Envenomation Poisoning Snake Bites Wounds and Injuries

Sex eligibility

All sexes

Study type

Observational

Primary location

Jubilee Mission Medical College and Research Institute

Thrissur, Kerala, 680005, India

About this study

Hump-nosed pit viper bites are the second most common snakebite presented to our institute as evidenced by the data in our snakebite registers. Acute kidney injury is reported in nearly 10% of the cases in our institute.

Since 2016, the participating institute maintains a snakebite register that records the patient's name, hospital number, date and time of the bite, hospital admission, and snake identification data after expert confirmation, if done. The investigators intend to review the cases with confirmed Hypnale envenomation and describe the clinical and laboratory profile of patients and their course of hospitalization.

Hump-nosed pit viper envenomation, the venom components, and the pharmacodynamics of the venom are unique to the region that it has missed the attention of many experts in the field. The current available polyvalent antivenom does not utilize the venom of Hypnale. Yet, antivenom is used by physicians for snakebites even when the culprit snake is identified, citing many reasons. The reasons range from snake misidentification to doubts as to whether para-specific neutralization capability exists for the available polyvalent antivenom. Often fear of medicolegal culpability in denying antivenom in a case of 'snake envenomation', and confusion as to whether or not to approach it syndromically and symptomatically rather than relying on the species identification also comes into play.

Who can participate

Only the study team can determine whether someone qualifies for participation.

  • Inclusion Criteria:

Case records of all snakebite in which the specimen brought is identified as Hump-nosed pit viper (Hypnale hypnale)

Exclusion criteria

  • Incomplete case records from which no meaningful data can be abstracted.

Treatment and study plan

Antivenom Snakes

Drug

No specific antivenom exists for a bite by Hypnale hypnale yet most patients are treated with non-specific antivenoms, risking reactions without hope of benefit. In this study we compare patients With Hypnale Hypnale Bite receiving Antivenom vrs patients With Hypnale Hypnale Bite not receiving Antivenom.

Other names: The polyvalent f(ab')2 antibody

Primary outcomes

  1. Mortality among patients administered antivenom compared to those who did not received the antivenom

    Time frame: 3 months

    Mortality among patients administered antivenom compared to those who did not received the antivenom for local or systemic signs of envenomation

  2. Morbidity among patients administered antivenom compared to those who did not received the antivenom

    Time frame: 3 months

    Morbidity among patients administered antivenom compared to those who did not received the antivenom for local or systemic signs of envenomation

Secondary outcomes

  1. Clinical profile of patients with Hypnale hypnale envenomation

    Time frame: 3 months

    Clinical profile of patients with confirmed bite Hypnale hypnale with regards to local or systemic signs of envenomation

  2. Laboratorical profile of patients with Hypnale hypnale envenomation

    Time frame: 3 months

    Laboratorical profile of patients with confirmed bite Hypnale hypnale with regards to local or systemic signs of envenomation

Sponsors and collaborators

Lead sponsor

Jubilee Mission Medical College and Research Institute

Other

Registry information

Official study title

Hump-nosed Pit Viper Bite: A Review of Cases to Understand the Clinical Profile of Patients and the Role of Antivenom Administration, at a Tertiary Care Centre in Kerala, South India

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Jul 20, 2023
Registry last updated
Jul 20, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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