- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03170297
SC2i VIPER: EnVenomation Investigation Pilot to Evaluate Recovery (VIPER)
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Allan M Kirk, PHD
- Phone Number: 919-681-3445
- Email: allan.kirk@duke.edu
Study Contact Backup
- Name: Alexander Limkakeng, MD
- Phone Number: 919-681-0196
- Email: alexander.limkakeng@duke.edu
Study Locations
-
-
North Carolina
-
Durham, North Carolina, United States, 27710
- Recruiting
- Duke University Health Systems
-
Contact:
- Alexander Limkakeng, MD
- Phone Number: 919-681-0196
- Email: alexander.limkakeng@duke.edu
-
Contact:
- Allan Kirk, MD PHD
- Phone Number: 919-681-3445
- Email: allan.kirk@duke.edu
-
Principal Investigator:
- Allan Kirk, MD PHD
-
Sub-Investigator:
- Alexander Limkakeng, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
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
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
Collaborators
Investigators
- Study Director: Eric A Elster, MD, Uniformed Services University of the Health Sciences
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
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)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
Clinical Trials on Critical Illness
-
Duke UniversityNational Institute of Neurological Disorders and Stroke (NINDS); National Institutes...CompletedNeonatal Critical Illness | Pediatric Critical IllnessUnited States
-
Yale UniversityNational Institute on Aging (NIA)RecruitingCritical Illness | Illness, CriticalUnited States
-
McMaster UniversityLondon Health Sciences Centre; McMaster Children's Hospital; Canadian Critical...CompletedPediatric Critical IllnessCanada
-
Boston Children's HospitalCompleted
-
St Helens & Knowsley Teaching Hospitals NHS TrustManchester University NHS Foundation TrustCompleted
-
Hospital de Clinicas de Porto AlegreUnknownCritical Illness PolyneuropathiesBrazil
-
Sándor BeniczkyUniversity of Aarhus; Danish Council for Independent Research; Søster og Verner...CompletedCritical Illness Myopathy | Myopathy Critical IllnessDenmark
-
University Hospital Birmingham NHS Foundation TrustCompletedRehabilitation After Critical Illness
-
Peking Union Medical College HospitalBaxter Healthcare CorporationUnknownNutrition Therapy for Critical Illness
-
Assistance Publique - Hôpitaux de ParisRecruitingCritical Illness Related Corticosteroids InsufficiencyFrance
Clinical Trials on Research interventions of blood sampling and data collection
-
Hospices Civils de LyonNot yet recruitingObesity | Sarcopenic Obesity | Bariatric Surgery | Binge Eating Disorder | Psychotropic Drugs | Syndromic Obesity | Iatrogenic ObesityFrance
-
Centre Hospitalier Universitaire DijonRecruiting
-
GlaxoSmithKlineCompletedPertussis | Pertussis VaccinesHungary
-
Brugmann University HospitalRecruitingChronic Kidney DiseasesBelgium
-
Centre Hospitalier Universitaire DijonRecruiting
-
University Hospital, Basel, SwitzerlandSwiss National Science FoundationRecruitingLiver Failure | Acute-On-Chronic Liver Failure | Liver Disease | Cirrhosis of the LiverSwitzerland, United Kingdom
-
Centre Hospitalier de CayenneCentre Hospitalier de Kourou; Centre Hospitalier de l'Ouest Guyanais; Centres... and other collaboratorsCompletedFever | Dengue | Pregnancy Preterm | Infant, Newborn | Women | Parturition; PrecipitateFrench Guiana
-
University Hospital, MontpellierRecruitingRheumatoid Arthritis | FibromyalgiaFrance
-
Assistance Publique Hopitaux De MarseilleCompletedCardiovascular Diseases | Atherosclerosis | Percutaneous Coronary InterventionFrance
-
Gritstone bio, Inc.CompletedColorectal Cancer | Non Small Cell Lung Cancer | Gastroesophageal Adenocarcinoma | Pancreatic Ductal Adenocarcinoma | Urothelial CarcinomaUnited States