Scorpion StingsNCT03622125
Decrease in Temperature as a Pagtonomic Sign by Scorpion Sting
An observational study of Scorpion Stings, run by Mexican Red Cross at 1 site in Mexico.
Trial summary
The scorpion sting is a medical disease, for the signs and symptoms presented; Sometimes patients do not know the animal that causes these symptoms; the bibliography marks the decrease in temperature as a sign to be presented. Read more about this study
- Who is it for?
- Ages 3 to 90 years
- Conditions the study is for
- Scorpion Stings
- What is being tested?
- Vital signs
- How many people
- 184 participants
- Where
- 1 siteMexico
- Study dates
- 20 May 2017to 30 Jul 2017
- 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 3 to 90 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Person who has been scorpion sting and present signs and symptoms of poisoning to will applied a treatment in the city of León, Guanajuato
Who may be able to join
- Scorpion sting
- All sex
- 3 - 90 ages
Who cannot join
- Application of ice at the sting site
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Decrease in Temperature by Scorpion Sting: a Pagtonomic Sign
The scorpion sting is a medical disease, for the signs and symptoms presented; Sometimes patients do not know the animal that causes these symptoms; the bibliography marks the decrease in temperature as a sign to be presented.
Read the detailed description
The scorpion sting is a medical emergency where 184 patients from the state of Guanajuato were divided into 2 groups according to the type of antivenom administered, the dose of antivenom were at the discretion of the attending physician, Birmex (n = 117) and Alacramyn (n = 67) for the temperature record of the site of sting and other vital signs, this to compare it with the bibliography as a pathognomonic sign.
- Conditions
- Scorpion Stings
- Being tested
- Vital signs
- Medical subject headings
- Scorpion Stings
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vital signsDiagnostic test
Axillary temperature sampling, at the site of the scorpion sting and the contralateral site with infrared thermometer, and heart rate, respiratory rate and blood pressure on admission, 30 minutes after applying the vial and the medical discharge
| Study group | Role | What they receive |
|---|---|---|
| 1 | Patients who apply anti-scorpion venom serum Birmex at the discretion of the attending physician were given vital signs. Receives: Diagnostic Test: Vital signs | |
| 2 | Patients who apply anti-scorpion venom serum Alacramyn at the discretion of the attending physician were given vital signs. Receives: Diagnostic Test: Vital signs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Temperature change
Temperature at the sting site, contralateral site and axillary in degrees celcius
Measured: 0, 30 and 120 minutes
Secondary outcomes (3)
Blood preasure
Systolic and diastolic in mmHg
Measured: 0, 30 and 120 minutes
Heart rate
Beats per minute
Measured: 0, 30 and 120 minutes
Respiratory rate
Breaths per minute
Measured: 0, 30 and 120 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2018
- Study start20 May 2017
- Primary completion15 Jun 2017
- Study completion30 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Scorpion StingsStudies 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
- Cross-sectional
- Enrolment
- 184 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mexican Red Cross
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto Bioclon S.A. de C.V.
- Responsible party
- Principal investigator, Josue Saul Almaraz Lira, Mexican Red Cross
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03622125
- Sponsor's protocol ID
- CRM-Alacranes-2017
- Status last verified
- Aug 2018
- First submitted
- 24 Jul 2018
- Last updated
- 15 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Isbister GK, Bawaskar HS. Scorpion envenomation. N Engl J Med. 2014 Jul 31;371(5):457-63. doi: 10.1056/NEJMra1401108. No abstract available.
PubMed 25075837
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Decrease in Temperature by Scorpion Sting: a Pagtonomic Sign
- ClinicalTrials.gov ID
- NCT03622125
- Acronym / sponsor ID
- CRM-Alacranes-2017
- Conditions
- Scorpion Stings
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 184 participants (actual)
- Lead sponsor
- Mexican Red CrossUniversity, hospital or other
- Collaborators
- Instituto Bioclon S.A. de C.V.
- Study start
- 20 May 2017 (actual)
- Primary completion
- 15 Jun 2017 (actual)
- Study completion
- 30 Jul 2017 (actual)
- First posted
- 9 Aug 2018 (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.
The scorpion sting is a medical disease, for the signs and symptoms presented; Sometimes patients do not know the animal that causes these symptoms; the bibliography marks the decrease in temperature as a sign to be presented.
Detailed description
The scorpion sting is a medical emergency where 184 patients from the state of Guanajuato were divided into 2 groups according to the type of antivenom administered, the dose of antivenom were at the discretion of the attending physician, Birmex (n = 117) and Alacramyn (n = 67) for the temperature record of the site of sting and other vital signs, this to compare it with the bibliography as a pathognomonic sign.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Diagnostic Test: Vital signsPatients who apply anti-scorpion venom serum Birmex at the discretion of the attending physician were given vital signs. |
| 2 | – | Diagnostic Test: Vital signsPatients who apply anti-scorpion venom serum Alacramyn at the discretion of the attending physician were given vital signs. |
Who may qualify
- Ages
- 3 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Person who has been scorpion sting and present signs and symptoms of poisoning to will applied a treatment in the city of León, Guanajuato
Key inclusion criteria (3 listed)
- Scorpion sting
- All sex
- 3 - 90 ages
Key exclusion criteria (1 listed)
- Application of ice at the sting site
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 |
|---|---|---|
| Vital signsAxillary temperature sampling, at the site of the scorpion sting and the contralateral site with infrared thermometer, and heart rate, respiratory rate and blood pressure on admission, 30 minutes after applying the vial and the medical discharge | Diagnostic test | 1, 2 |
Primary outcome
Temperature change
Time frame: 0, 30 and 120 minutes
Temperature at the sting site, contralateral site and axillary in degrees celcius
3 secondary outcomes
Blood preasure
Time frame: 0, 30 and 120 minutes
Heart rate
Time frame: 0, 30 and 120 minutes
Respiratory rate
Time frame: 0, 30 and 120 minutes
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 15 Aug 2019.
- Background: PubMed 25075837Isbister GK, Bawaskar HS. Scorpion envenomation. N Engl J Med. 2014 Jul 31;371(5):457-63. doi: 10.1056/NEJMra1401108. No abstract available.
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Scorpion Stings, run by Mexican Red Cross at 1 site in Mexico.
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 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 15 Aug 2019. 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 Mexico. 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?
Temperature change (time frame: 0, 30 and 120 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03622125, which also lists 1 linked publication.
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 15 Aug 2019.