Critical IllnessVIPERNCT03170297
SC2i VIPER: EnVenomation Investigation Pilot to Evaluate Recovery
An observational study of Critical Illness, run by Henry M. Jackson Foundation for the Advancement of Military Medicine at 1 site in United States.
Trial summary
The purpose of this study is to pilot data for a systematic molecular characterization of pathophysiologic perturbations incurred by snake envenomation and compare this to other inflammatory physiologic states such as trauma and sepsis. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Critical Illness
- What is being tested?
- Research interventions of blood sampling and data collection
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 5 May 2017to 15 Dec 2019
- 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 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: -This study may analyze participants with snakebite envenomation along with similarly previously enrolled subjects who have suffered traumatic injury or sepsis who will serve as matched controls.
Who may be able to join
- Patients enrolled into the Surgical Critical Care Initiative Tissue and Data Acquisition Protocol (NCT02182180) who have suffered a snakebite envenomation (enrolled under "Group 5: Non-traumatic conditions: individuals with non-traumatic causes of organ or system failure that mirror the phenotype of traumatic complications in Group 1") are eligible to be included in this study.
- Adult patients (18 years of age or older) in a manner that is sensitive to the inclusion of women and members of underserved minority groups.
- Potential participants or legally authorized representative (LAR) will be originally identified by clinical team, as described under Pro00054947 (NCT02182180). Only participants enrolled in Pro00054947 (NCT02182180) will be recruited for this sub-study
Who cannot join
- Pregnant women will be excluded from the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Health Systems
Durham, North Carolina, 27710
About this study
The purpose of this study is to pilot data for a systematic molecular characterization of pathophysiologic perturbations incurred by snake envenomation and compare this to other inflammatory physiologic states such as trauma and sepsis. This sub-study will analyze samples of participants enrolled under the parent study "Surgical Critical Care Initiative Tissue and Data Acquisition Protocol".
Read the detailed description
The goal of this study is to pilot data for a systematic molecular characterization of pathophysiologic perturbations incurred by snake envenomation and compare this to other inflammatory physiologic states such as trauma and sepsis. The investigators will characterize transcriptomic and immune biomarker response to varying clinical severities of snakebite envenomation and compare to that of sepsis and traumatic injury.
This sub-study will analyze samples of participants enrolled under a previously IRB-approved protocol, "Surgical Critical Care Initiative Tissue and Data Acquisition Protocol (SC2i TDAP)". All participants eligible for protocol SC2i TDAP (NCT 02182180) are eligible to be included in the current proposal, and conversely, the investigators will not enroll any participants in the current protocol who is not enrolled in SC2i TDAP. Participants enrolled under that protocol who have suffered snakebite envenomation will undergo additional procedure of follow up phone call 3, 7, 14, 21 and 28 days after discharge from the emergency department or hospital to fill out the PSFS via phone. All labs and other procedures will otherwise be as described in SC2i TDAP.
- Conditions
- Critical Illness
- Being tested
- Research interventions of blood sampling and data collection
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Research interventions of blood sampling and data collectionOther
Patient-Specific Functional Scale (PSFS) survey will be administered to patients to record symptoms at both the time of evaluation in the emergency department and in follow up by phone at 3, 7, 14, 21 and 28 days after discharge from the emergency department or hospital. The rest of the patients' care will be as usual care, and patients will have had research interventions of blood sampling and data collection as noted in the previously approved SC2i Tissue Data Acquisition Protocol (TDAP) Pro00054947 (ClinicalTrial.gov ID: NCT02182180).
What is being measured
The primary outcome is the main question the study is designed to answer.
Survey and Data
Patient Specific Functional Scale survey and piloting data for a systematic molecular characterization of pathophysiologic perturbations incurred by snake envenomation and compare this to other inflammatory physiologic states such as trauma and sepsis.
Measured: 30 days after initial bite for the survey
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2017
- Study start5 May 2017
- Primary completion15 Dec 2019
- Study completion15 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical IllnessStudies 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
- Prospective
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Henry M. Jackson Foundation for the Advancement of Military Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Uniformed Services University of the Health Sciences, United States Department of Defense, Duke University, Emory University, Grady Health System, Walter Reed National Military Medical Center
- Responsible party
- Sponsor
- Investigators
- Eric A Elster, MD, Study director, Uniformed Services University of the Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03170297
- Sponsor's protocol ID
- Pro00082061
- Other IDs
- HT9404-13-1-0032
- Acronym
- VIPER
- Status last verified
- Aug 2025
- First submitted
- 26 May 2017
- Last updated
- 12 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The PI will ensure that there is no unauthorized use of the data or samples. As this study is unblinded and nonrandomized it is felt that a formal Data Safety Monitoring Board is not necessary to insure the prompt implementation of patient safeguards. Data for this sub-study will be entered in a separate REDCap database, with data specific to this sub-study (i.e., PSFS, hospital re-admissions from phone follow-ups). This database will only be available to appropriately delegated key personnel. Any data shared outside of Duke key personnel will be de-identified,
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SC2i VIPER: EnVenomation Investigation Pilot to Evaluate Recovery
- ClinicalTrials.gov ID
- NCT03170297
- Acronym / sponsor ID
- VIPER / Pro00082061
- Conditions
- Critical Illness
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Henry M. Jackson Foundation for the Advancement of Military MedicineUniversity, hospital or other
- Collaborators
- Uniformed Services University of the Health Sciences, United States Department of Defense, Duke University, Emory University, Grady Health System, Walter Reed National Military Medical Center
- Study start
- 5 May 2017 (actual)
- Primary completion
- 15 Dec 2019 (actual)
- Study completion
- 15 Dec 2019 (actual)
- First posted
- 31 May 2017 (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 purpose of this study is to pilot data for a systematic molecular characterization of pathophysiologic perturbations incurred by snake envenomation and compare this to other inflammatory physiologic states such as trauma and sepsis. This sub-study will analyze samples of participants enrolled under the parent study "Surgical Critical Care Initiative Tissue and Data Acquisition Protocol".
Detailed description
The goal of this study is to pilot data for a systematic molecular characterization of pathophysiologic perturbations incurred by snake envenomation and compare this to other inflammatory physiologic states such as trauma and sepsis. The investigators will characterize transcriptomic and immune biomarker response to varying clinical severities of snakebite envenomation and compare to that of sepsis and traumatic injury.
This sub-study will analyze samples of participants enrolled under a previously IRB-approved protocol, "Surgical Critical Care Initiative Tissue and Data Acquisition Protocol (SC2i TDAP)". All participants eligible for protocol SC2i TDAP (NCT 02182180) are eligible to be included in the current proposal, and conversely, the investigators will not enroll any participants in the current protocol who is not enrolled in SC2i TDAP. Participants enrolled under that protocol who have suffered snakebite envenomation will undergo additional procedure of follow up phone call 3, 7, 14, 21 and 28 days after discharge from the emergency department or hospital to fill out the PSFS via phone. All labs and other procedures will otherwise be as described in SC2i TDAP.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- -This study may analyze participants with snakebite envenomation along with similarly previously enrolled subjects who have suffered traumatic injury or sepsis who will serve as matched controls.
Key inclusion criteria (3 listed)
- Patients enrolled into the Surgical Critical Care Initiative Tissue and Data Acquisition Protocol (NCT02182180) who have suffered a snakebite envenomation (enrolled under "Group 5: Non-traumatic conditions: individuals with non-traumatic causes of organ or system failure that mirror the phenotype of traumatic complications in Group 1") are eligible to be included in this study.
- Adult patients (18 years of age or older) in a manner that is sensitive to the inclusion of women and members of underserved minority groups.
- Potential participants or legally authorized representative (LAR) will be originally identified by clinical team, as described under Pro00054947 (NCT02182180). Only participants enrolled in Pro00054947 (NCT02182180) will be recruited for this sub-study
Key exclusion criteria (1 listed)
- Pregnant women will be excluded from the study.
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 |
|---|---|---|
| Research interventions of blood sampling and data collectionPatient-Specific Functional Scale (PSFS) survey will be administered to patients to record symptoms at both the time of evaluation in the emergency department and in follow up by phone at 3, 7, 14, 21 and 28 days after discharge from the emergency department or hospital. The rest of the patients' care will be as usual care, and patients will have had research interventions of blood sampling and data collection as noted in the previously approved SC2i Tissue Data Acquisition Protocol (TDAP) Pro00054947 (ClinicalTrial.gov ID: NCT02182180). | Other | – |
Primary outcome
Survey and Data
Time frame: 30 days after initial bite for the survey
Patient Specific Functional Scale survey and piloting data for a systematic molecular characterization of pathophysiologic perturbations incurred by snake envenomation and compare this to other inflammatory physiologic states such as trauma and sepsis.
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 12 Aug 2025.
- Henry M. Jackson Foundation for the Advancement of Military MedicineLink provided by the sponsor.
- Uniformed Services University of Health SciencesLink provided by the sponsor.
- Duke University Medical CenterLink provided by the sponsor.
- Individual participant dataSharing planned: No. The PI will ensure that there is no unauthorized use of the data or samples. As this study is unblinded and nonrandomized it is felt that a formal Data Safety Monitoring Board is not necessary to insure the prompt implementation of patient safeguards. Data for this sub-study will be entered in a separate REDCap database, with data specific to this sub-study (i.e., PSFS, hospital re-admissions from phone follow-ups). This database will only be available to appropriately delegated key personnel. Any data shared outside of Duke key personnel will be de-identified,
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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.
Eric A Elster, MD study director
Uniformed Services University of the Health Sciences
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 Critical Illness, run by Henry M. Jackson Foundation for the Advancement of Military Medicine 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 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 12 Aug 2025. 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?
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?
Survey and Data (time frame: 30 days after initial bite for the survey). 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 12 Aug 2025.