NCT03170297

SC2i VIPER: EnVenomation Investigation Pilot to Evaluate Recovery

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 15 (actual)
• Sponsor: Henry M. Jackson Foundation for the Advancement of Military Medicine · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

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".

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

Interventions

Type	Name	Description
OTHER	Research interventions of blood sampling and data collection	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).

Timeline

• Start date: 2017-05-05
• Primary completion: 2019-12-15
• Completion: 2019-12-15
• First posted: 2017-05-31
• Last updated: 2025-08-12

Locations

1 site across 1 country: United States