Envenomation, SnakebiteNCT05954806
Clinical Profile and Antivenom Use in Hump-nosed Pit Viper Bites in Kerala, South India: A Review.
An observational study of Envenomation, Snakebite and Envenomation, run by Jubilee Mission Medical College and Research Institute at 1 site in India.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Envenomation, Snakebite, Envenomation
- What is being tested?
- Antivenom Snakes
- How many people
- 41 participants
- Where
- 1 siteIndia
- Study dates
- 12 Mar 2022to 12 Sep 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Child, Adult, Older adult
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.
Who may be able to join
None listed.
Who cannot join
- Incomplete case records from which no meaningful data can be abstracted.
Trial locations and contacts
1 site in 1 country.
India1 site
Jubilee Mission Medical College and Research Institute
Thrissur, Kerala, 680005
About this study
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
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.
- Conditions
- Envenomation, Snakebite, Envenomation
- Being tested
- Antivenom Snakes
- Keywords
- Hump-nosed pit viper, anti venom
- Medical subject headings
- Snake Bites
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Antivenom SnakesDrug
Also called The polyvalent f(ab')2 antibody
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.
| Study group | Role | What they receive |
|---|---|---|
| Patients With Hypnale Hypnale Bite receiving Antivenom | Patients With Hypnale Hypnale Bite receiving Antivenom for local or systemic signs of envenomation Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 3 months
Secondary outcomes (2)
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
Measured: 3 months
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
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2023
- Study start12 Mar 2022
- Primary completion12 Jun 2022
- Study completion12 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Envenomation, SnakebiteStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Other
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jubilee Mission Medical College and Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Siju V Abraham, MD, Jubilee Mission Medical College and Research Institute
- Investigators
- Siju V Abraham, MD, Principal investigator, Jubilee Mission Medical College and Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05954806
- Sponsor's protocol ID
- 87/21/IEC/JMMC&RI
- Status last verified
- Jul 2023
- First submitted
- 16 Jun 2023
- Last updated
- 20 Jul 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05954806
- Acronym / sponsor ID
- 87/21/IEC/JMMC&RI
- Conditions
- Envenomation, Snakebite, Envenomation
- Keywords
- Hump-nosed pit viper, anti venom
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Jubilee Mission Medical College and Research InstituteUniversity, hospital or other
- Study start
- 12 Mar 2022 (actual)
- Primary completion
- 12 Jun 2022 (actual)
- Study completion
- 12 Sep 2022 (actual)
- First posted
- 20 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 .
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
- Observational model
- Case-control
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients With Hypnale Hypnale Bite receiving Antivenom | – | Drug: Antivenom SnakesPatients With Hypnale Hypnale Bite receiving Antivenom for local or systemic signs of envenomation |
| Patients With Hypnale Hypnale Bite not receiving Antivenom | – | –Patients With Hypnale Hypnale Bite not receiving Antivenom for local or systemic signs of envenomation |
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- Incomplete case records from which no meaningful data can be abstracted.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Antivenom SnakesAlso: The polyvalent f(ab')2 antibodyNo 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. | Drug | Patients With Hypnale Hypnale Bite receiving Antivenom |
Primary outcome
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
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
2 secondary outcomes
Clinical profile of patients with Hypnale hypnale envenomation
Time frame: 3 months
Laboratorical profile of patients with Hypnale hypnale envenomation
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2023.
Related trials for Envenomation, Snakebite
RecruitingObservational study
Mapping Snakebite Risk in Ghana and Rwanda
Snakebite, Snake Envenomation
RecruitingObservational study
Predictive Accuracy of the Snakebite Severity Score (SSS) in Identifying Syndrome-Specific Core Outcome Parameters Among Envenomated Patients Presenting to the Emergency Department
Snake Bite
Enrolling by invitationObservational study
Multicenter Application Verification and Effect Evaluation of Artificial Intelligence-Based Snake Species Identification System in the Diagnosis and Treatment of Snakebites
Snake Bite
RecruitingObservational study
Polyvalent Antivenom (Premium-PANAF) for Snakebite Envenoming in Ethiopia
Snake Envenomation
Not yet recruitingPhase 2
Trial of Oral Community SVMP INhibitors for Snakebite
Snakebite
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Siju V Abraham, MD principal investigator
Jubilee Mission Medical College and Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Envenomation, Snakebite and Envenomation, run by Jubilee Mission Medical College and Research Institute at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality among patients administered antivenom compared to those who did not received the antivenom (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2023.