Status:
TERMINATED
Peripheral Venous Analysis (PIVA) for Predicting Volume Responsiveness and Fluid Status
Lead Sponsor:
Vanderbilt University Medical Center
Collaborating Sponsors:
Baxter Healthcare Corporation
Conditions:
Systemic Inflammatory Response Syndrome
Distributive Shock
Eligibility:
All Genders
18+ years
Brief Summary
The aim of this study is to determine the effects of fluid alternations, hemodynamic changes, mechanical ventilation, pharmacologic agents, positional changes, and comorbidities on the Peripheral Intr...
Detailed Description
Intravascular volume status determination remains elusive. Standard vital sign monitoring, including heart rate and blood pressure, fails to detect intravascular volume depletion and volume overload. ...
Eligibility Criteria
Inclusion
- Cardiac Catheterization
- Inclusion criteria:
- Patients undergoing right heart catheterization or left and right heart catheterizaton; Age \>=18
- Exclusion criteria:
- Cardiac assist devices (intra-aortic balloon pump, ventricular assist devices, and extra corporeal membrane oxygenation), ongoing ACLS, aortic or mitral valve disease greater than mild in severity, aortic or mitral valve replacement, active irregular heart rhythm, patients with restrictive cardiomyopathies (cardiac amyloidosis), constrictive cardiac disease (constrictive pericarditis or cardiac-tamponade), congenital heart disease other than foramen ovale, repaired atrial or ventricular septal defect, female patients who are pregnant or lactating, or patients with known psychiatric or neurological disease who are unable to consent. Patients who do not have a functional peripheral IV as part of standard care. Pressors, starches, lipids, propofol, or D10 or higher running through the PIVA line.
- Distributive Shock
- Cardiopulmonary bypass for cardiac procedures within one hour of arriving in the ICU post-op; Age \>=18
Exclusion
- Cardiac assist devices (intra-aortic balloon pump, ventricular assist devices, and extracorporeal membrane oxygenation), ongoing ACLS, severe tricuspid regurgitation or stenosis, patient with restrictive cardiomyopathies (cardiac amyloidosis), patients receiving pulmonary vasodilators (nitric oxide, sodium nitroprusside, sildenafil), atrial fibrillation, congenital heart disease, female patients who are pregnant or lactating, or patients with known psychiatric or neurological disease who are unable to consent. Patients who do not have a functional peripheral IV as part of standard care.
- Vasoactive and Inotropic Agents
- Inclusion Criteria:
- Hospitalized patients with central venous access and pulmonary arterial catheter in place, requiring infusion of vasoactive and/or inotropic agents; Age \>=18
Key Trial Info
Start Date :
January 8 2018
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2020
Estimated Enrollment :
180 Patients enrolled
Trial Details
Trial ID
NCT03407287
Start Date
January 8 2018
End Date
December 1 2020
Last Update
April 12 2021
Active Locations (1)
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1
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37212