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临床试验/NCT05954806
NCT05954806已完成不适用

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

Jubilee Mission Medical College and Research Institute1 个研究点 分布在 1 个国家目标入组 41 人开始时间: 2022年3月12日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
41
试验地点
1
主要终点
Morbidity among patients administered antivenom compared to those who did not received the antivenom

研究概览

简要总结

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 .

详细描述

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.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Other

入排标准

性别
All
接受健康志愿者

入选标准

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

排除标准

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

研究组 & 干预措施

Patients With Hypnale Hypnale Bite receiving Antivenom

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

干预措施: Antivenom Snakes (Drug)

结局指标

主要结局

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

时间窗: 3 months

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

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

时间窗: 3 months

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

次要结局

  • Laboratorical profile of patients with Hypnale hypnale envenomation(3 months)
  • Clinical profile of patients with Hypnale hypnale envenomation(3 months)

研究者

发起方
Jubilee Mission Medical College and Research Institute
申办方类型
Other
责任方
Principal Investigator
主要研究者

Siju V Abraham, MD

Associate professor

Jubilee Mission Medical College and Research Institute

研究点 (1)

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