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Rattlesnake Bite (Diagnosis)NCT04188899

Point-of-care Ultrasound in the Assessment of Snake Bite

An observational study of Rattlesnake Bite (Diagnosis), run by University of Arizona at 1 site in United States.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

Early identification of tissue injury from a rattlesnake bite is critical to prevent complications and reduce health care costs. Given the limitations of clinical assessment, there is a need to develop a more objective reproducible, anatomically detailed diagnostic tool for to accurately assess tissue damage and… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Rattlesnake Bite (Diagnosis)
How many people
150 participants
Where
1 siteUnited States
Study dates
31 Aug 2026to 31 Aug 2030
Phase
Observational
Are there results?
Not yet: the study is under way

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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Emergency department patients presenting with Rattle snake envenomation

Who may be able to join

  • Adult patients (18 years and older)
  • Both genders
  • Complaint of snake bite

Who cannot join

  • If they are unwilling to provide informed consent
  • Hemodynamically unstable patients (shock respiratory distress, altered mental status, and cardiorespiratory arrest)
  • All vulnerable patient populations, e.g., children, pregnant patients, prisoners, and patients unable to verbally consent due to cognitive impairment

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Srikar Adhikari, MD, MS contact

520-621-3623

sadhikari@aemrc.arizona.edu

United States1 site
  • Banner University Medical Center-Tucson

    Tucson, Arizona, 85724

    Srikar Adhikari, MD, MS

Other trials in United States

About this study

Early identification of tissue injury from a rattlesnake bite is critical to prevent complications and reduce health care costs. Given the limitations of clinical assessment, there is a need to develop a more objective reproducible, anatomically detailed diagnostic tool for to accurately assess tissue damage and assist with timely administration of antivenom, if needed. Emergency physician performed point-of-care ultrasonography has been shown to be beneficial in the diagnosis and management of skin and soft tissue infections. The innovative use of bedside ultrasound technology can provide new information to individualize antivenom treatment and to improve patient outcomes. The objectives of this study is to compare clinical assessment and bedside ultrasound findings in the detection of tissue injury in emergency department patients with rattle snakebite and determine if bedside ultrasound can alter management (antivenom dosing) in emergency department patients with rattle snakebite.

Read the detailed description

Arizona has the highest per capita rate of rattlesnake envenomation (the process by which venom is injected by the bite of a venomous animal) in the United States leading to millions of dollars in health care costs. Local tissue destruction typically manifests in the first few hours after snakebite and can progress over days or weeks leading to long-term complications such as muscle, nerve, and circulatory damage. The cornerstone in the treatment of rattlesnake envenomation is accurate estimation of progression of local tissue damage and timely administration of antivenom to halt the progression of venom effects. The initial decision to administer antivenom is based on clinical parameters such as edema, induration, bullae and blisters. The need for repeat doses of antivenom is determined by serial clinical assessments and laboratory parameters. However, no definitive clinical or laboratory parameters currently exist. The current practice is limited by inter-observer variability in the clinical assessment and the inability to accurately assess the extent of tissue injury. In a significant number of cases, it is difficult to accurately track the progression of the venom effects until they become more pronounced and severe. With the limitations of clinical assessment, administration of antivenom is delayed potentially resulting in poor patient outcomes. A further complicating factor is that not all rattlesnake bites result in envenomation. A substantial number of bites by rattlesnakes can result in "dry bite" in which snake venom is not transferred from snake to human and thus will not cause tissue destruction.4 Because of limitations of clinical assessments, these patients receive antivenom even though it is not necessary. This liberal and inappropriate use of antivenom is not cost effective and can also affect patient safety.

Early identification of tissue injury from a rattlesnake bite is critical to prevent complications and reduce health care costs. Given the limitations of clinical assessment, there is a need to develop a more objective reproducible, anatomically detailed diagnostic tool for to accurately assess tissue damage and assist with timely administration of antivenom, if needed. Emergency physician performed point-of-care ultrasonography has been shown to be beneficial in the diagnosis and management of skin and soft tissue infections. The innovative use of bedside ultrasound technology can provide new information to individualize antivenom treatment and to improve patient outcomes. The quick, noninvasive nature and repeatability of point-of-care ultrasonography makes it an ideal objective tool for the assessment of emergency department (ED) patients with rattle snakebites. Ultrasound technology can reveal subcutaneous edema, localized fluid collections, tissue necrosis, and muscle contractions resulting from a rattlesnake bite.6 Point-of-care ultrasonography performed by emergency physicians can detect the tissue injury that is not evident on clinical assessment and accurately track the patterns of injury prior to their external manifestations. This innovative approach can expedite treatment in patients with rattle snake envenomation thereby preventing complications such as coagulopathy (a condition in which the blood's ability to clot is impaired) and compartment syndrome (excessive pressure build up inside an enclosed space in the body). Additionally ultrasound can eliminate the inappropriate use of antivenom in patients with dry bite potentially reducing health care costs and improving patient safety.

Our preliminary experience and prior literature suggests that point-of-care ultrasound can detect subcutaneous edema, help clinicians to make an accurate assessment of proximal progression of local findings due to a snake bite and can expedite the consultation and appropriate treatment in patients with snake bite.The objectives of this study is to compare clinical assessment and bedside ultrasound findings in the detection of tissue injury in emergency department patients with rattle snakebite and determine if bedside ultrasound can alter management (antivenom dosing) in emergency department patients with rattle snakebite.

Medical subject headings
Disease

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of participants in whom ultrasound detected progress of skin changes earlier than physical examination

    Sonographic skin changes

    Measured: First 10 hours of Emergency Department encounter

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Dec 2019
  2. Study start31 Aug 2026 (estimated)
  3. Primary completion31 Aug 2029 (estimated)
  4. Study completion31 Aug 2030 (estimated)

Resources

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
Cohort
Time perspective
Prospective
Enrolment
150 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04188899
Sponsor's protocol ID
1910093637
Status last verified
Jul 2026
First submitted
2 Dec 2019
Last updated
17 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

An observational study of Rattlesnake Bite (Diagnosis), run by University of Arizona at 1 site in United States.

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 3 inclusion and 3 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: opening soon, as of the sponsor's last update on 17 Jul 2026. 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 United States. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Srikar Adhikari, MD, MS (520-621-3623, sadhikari@aemrc.arizona.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of participants in whom ultrasound detected progress of skin changes earlier than physical examination (time frame: First 10 hours of Emergency Department encounter). 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 17 Jul 2026.

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