SC2i VIPER: EnVenomation Investigation Pilot to Evaluate Recovery (VIPER)

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".

Study Overview

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 Type

Observational

Enrollment (Anticipated)

15

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Recruiting
        • Duke University Health Systems
        • Contact:
        • Contact:
        • Principal Investigator:
          • Allan Kirk, MD PHD
        • Sub-Investigator:
          • Alexander Limkakeng, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
30 days after initial bite for the survey

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 5, 2017

Primary Completion (Anticipated)

September 1, 2020

Study Completion (Anticipated)

October 1, 2020

Study Registration Dates

First Submitted

May 26, 2017

First Submitted That Met QC Criteria

May 30, 2017

First Posted (Actual)

May 31, 2017

Study Record Updates

Last Update Posted (Actual)

September 6, 2019

Last Update Submitted That Met QC Criteria

September 3, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • Pro00082061
  • HT9404-13-1-0032 (Other Identifier: HJF/USUHS)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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,

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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