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CompletedNCT05954806Updated Jul 20, 2023

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

An observational study in Envenomation, Snakebite and Envenomation, sponsored by Jubilee Mission Medical College and Research Institute. Completed at 1 site in India. Per ClinicalTrials.gov, last updated 2023-07-20.

Sponsored by Jubilee Mission Medical College and Research Institute · Observational

Study type
Observational
Model
Case-control
Time perspective
Other
Enrollment
41
Sex
All
01

Study 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 .

Read the 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.

02

Conditions studied

  • Envenomation, Snakebite
  • Envenomation

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Keywords

  • Hump-nosed pit viper
  • anti venom
03

In context

Snake Bites

38 studies on the registry are indexed under Snake Bites; 11 are open to participants now.

This study's enrollment of 41 is below the median of 99 across 19 observational studies indexed under Snake Bites.

Browse Snake Bites studies →

Lead sponsor

Jubilee Mission Medical College and Research Institute is the lead sponsor of 25 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Incomplete case records from which no meaningful data can be abstracted.
05

Study design

Observational model
Case-control
Time perspective
Other
Enrollment
41 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

  • DrugAntivenom 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.

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

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 3 months

  2. 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

    Time frame: 3 months

Secondary outcomes

  1. Clinical profile of patients with Hypnale hypnale envenomation

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

    Time frame: 3 months

  2. Laboratorical profile of patients with Hypnale hypnale envenomation

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

    Time frame: 3 months

07

Study locations

1 site
  • Jubilee Mission Medical College and Research Institute
    Thrissur, Kerala 680005, India
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 20, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05954806
Lead sponsor
Jubilee Mission Medical College and Research Institute
Responsible party
Siju V Abraham, MD (Associate professor, Jubilee Mission Medical College and Research Institute) — Principal investigator
First posted
Jul 20, 2023
Start date
Mar 12, 2022
Primary completion
Jun 12, 2022
Completion
Sep 12, 2022
Last update
Jul 20, 2023

Study contacts

Siju V Abraham, MD
principal investigator · Jubilee Mission Medical College and Research Institute

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.

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Discussion

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