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

NCT05954806 | Completed

• 1 other identifier: 87/21/IEC/JMMC&RI
• Study Type: observational
• Target: 41
• Locations: 1 country
• Sites: 1

Brief Summary

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 .

Conditions

Envenomation, Snakebite; Envenomation

Keywords

Hump-nosed pit viper; anti venom

Outcome Measures

Primary Outcomes (2)

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

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

  3 months

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

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

  3 months

Secondary Outcomes (2)

• Clinical profile of patients with Hypnale hypnale envenomation

  3 months

• Laboratorical profile of patients with Hypnale hypnale envenomation

  3 months

Study Arms (2)

Patients With Hypnale Hypnale Bite receiving Antivenom

Patients With Hypnale Hypnale Bite receiving Antivenom for local or systemic signs of envenomation

Drug: Antivenom Snakes

Patients With Hypnale Hypnale Bite not receiving Antivenom

Patients With Hypnale Hypnale Bite not receiving Antivenom for local or systemic signs of envenomation

Interventions

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.

Also known as: The polyvalent f(ab')2 antibody

Patients With Hypnale Hypnale Bite receiving Antivenom

Eligibility Criteria

• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with Hypnale hypnale bite that were treated at a tertiary care centre in central Kerala, India during the period from April 2017 to December 2021.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Jubilee Mission Medical College and Research Institute: lead

Study Sites (1)

Jubilee Mission Medical College and Research Institute

Thrissur, Kerala, 680005, India

Location

MeSH Terms

Conditions

Snake Bites

Condition Hierarchy (Ancestors)

Bites and Stings; Poisoning; Chemically-Induced Disorders; Wounds and Injuries

Study Officials

• Siju V Abraham, MD

  Jubilee Mission Medical College and Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: June 16, 2023
• First Posted: July 20, 2023
• Study Start: March 12, 2022
• Primary Completion: June 12, 2022
• Study Completion: September 12, 2022
• Last Updated: July 20, 2023

Record last verified: 2023-07

Locations

IN (1)