SC2i VIPER: EnVenomation Investigation Pilot to Evaluate Recovery

NCT03170297 | Completed

• 2 other identifiers: Pro00082061HT9404-13-1-0032
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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. This sub-study will analyze samples of participants enrolled under the parent study "Surgical Critical Care Initiative Tissue and Data Acquisition Protocol".

Conditions

Critical Illness

Outcome Measures

Primary Outcomes (1)

• 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.

  30 days after initial bite for the survey

Interventions

Research interventions of blood sampling and data collection OTHER

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).

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.
• 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

You may not qualify if:

• Pregnant women will be excluded from the study.

Sponsors & Collaborators

• Henry M. Jackson Foundation for the Advancement of Military Medicine: lead
• Uniformed Services University of the Health Sciences: collaborator
• United States Department of Defense: collaborator
• Duke University: collaborator
• Emory University: collaborator
• Grady Health System: collaborator
• Walter Reed National Military Medical Center: collaborator

Study Sites (1)

Duke University Health Systems

Durham, North Carolina, 27710, United States

Location

Related Links

• Henry M. Jackson Foundation for the Advancement of Military Medicine
• Uniformed Services University of Health Sciences
• Duke University Medical Center

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples collected will be used for quantification of over one hundred micro RNA (levels will be assessed) as well as multiple markers of inflammation such as Interleukins 1-36 and their receptors, interferons and their receptors, tumor necrosis factors and their receptors, CCL and CXCL family chemokines and their receptors, macrophage and granulocyte colony stimulating factors and their receptors, and lymphocyte secreted products related to the action of these proteins will be evaluated. No genetic testing will be performed.

MeSH Terms

Conditions

Critical Illness

Interventions

Data Collection

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Eric A Elster, MD

  Uniformed Services University of the Health Sciences

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 26, 2017
• First Posted: May 31, 2017
• Study Start: May 5, 2017
• Primary Completion: December 15, 2019
• Study Completion: December 15, 2019
• Last Updated: August 12, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)