SC2i VIPER: EnVenomation Investigation Pilot to Evaluate Recovery
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Hospital |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - 80 |
| Updated: | 3/3/2019 |
| Start Date: | May 5, 2017 |
| End Date: | October 2019 |
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".
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".
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.
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.
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.
We found this trial at
1
site
Durham, North Carolina 27710
Principal Investigator: Allan Kirk, MD PHD
Phone: 919-681-3445
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