SC2i VIPER: EnVenomation Investigation Pilot to Evaluate Recovery

Critical Illness Clinical Trial

— VIPER  

Official title:

SC2i VIPER: EnVenomation Investigation Pilot to Evaluate Recovery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03170297
• Other study ID #: Pro00082061
• Secondary ID: HT9404-13-1-0032
• Status: Recruiting
• Start date: May 5, 2017
• Est. completion date: October 2020

Study information

• Verified date: September 2019
• Source: Henry M. Jackson Foundation for the Advancement of Military Medicine
• Contact: Allan M Kirk, PHD
• Phone: 919-681-3445
• Email: allan.kirk[@]duke.edu
• Is FDA regulated: No
• Study type: Observational

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: October 2020
• Est. primary completion date: September 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• Pregnant women will be excluded from the study.

Related Conditions & MeSH terms

• Critical Illness

Intervention

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).

Locations

Country	Name	City	State
United States	Duke University Health Systems	Durham	North Carolina

Sponsors (7)

Lead Sponsor	Collaborator
Henry M. Jackson Foundation for the Advancement of Military Medicine	Duke University, Emory University, Grady Health System, Uniformed Services University of the Health Sciences, United States Department of Defense, Walter Reed National Military Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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

External Links

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