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

Sponsor
Jubilee Mission Medical College and Research Institute (Other)
Overall Status
Completed
CT.gov ID
NCT05954806
Collaborator
(none)
41
1
6
6.8

Study Details

Study Description

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 .

Condition or Disease Intervention/Treatment Phase
  • Drug: Antivenom Snakes

Detailed Description

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.

Study Design

Study Type:
Observational
Actual Enrollment :
41 participants
Observational Model:
Case-Control
Time Perspective:
Other
Official 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
Actual Study Start Date :
Mar 12, 2022
Actual Primary Completion Date :
Jun 12, 2022
Actual Study Completion Date :
Sep 12, 2022

Arms and Interventions

Arm Intervention/Treatment
Patients With Hypnale Hypnale Bite receiving Antivenom

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

Drug: Antivenom Snakes
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
  • Patients With Hypnale Hypnale Bite not receiving Antivenom

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

    Outcome Measures

    Primary Outcome Measures

    1. Mortality among patients administered antivenom compared to those who did not received the antivenom [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 [3 months]

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

    Secondary Outcome Measures

    1. Clinical profile of patients with Hypnale hypnale envenomation [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 [3 months]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    • 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Jubilee Mission Medical College and Research Institute Thrissur Kerala India 680005

    Sponsors and Collaborators

    • Jubilee Mission Medical College and Research Institute

    Investigators

    • Principal Investigator: Siju V Abraham, MD, Jubilee Mission Medical College and Research Institute

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Siju V Abraham, MD, Associate professor, Jubilee Mission Medical College and Research Institute
    ClinicalTrials.gov Identifier:
    NCT05954806
    Other Study ID Numbers:
    • 87/21/IEC/JMMC&RI
    First Posted:
    Jul 20, 2023
    Last Update Posted:
    Jul 20, 2023
    Last Verified:
    Jul 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Siju V Abraham, MD, Associate professor, Jubilee Mission Medical College and Research Institute
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jul 20, 2023