Peripheral Venous Analysis (PIVA) for Predicting Volume Responsiveness and Fluid Status

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. Likewise, invasive monitoring is fraught with risk including vascular injury
and central line associated infections. As such, a minimally-invasive mechanism to overcome
the barriers of standard monitoring to detect volume status derangement, would be highly
valuable. The goal of the study is to perform a series of observational feasibility studies
in healthy and hospitalized subjects to determine effects of fluid alternations, hemodynamic
changes, mechanical ventilation, pharmacologic agents, positional changes, and comorbidities
on the PIVA signal

Systemic Inflammatory Response Syndrome

Inclusion criteria:

- Patients in the hospital who meet 2 of the 4 SIRS criteria.

- Temperature >38° C or less than <36° C

- Heart rate >90 beats/min

- Respiratory rate >20 breaths/min or PaCO2 <32 torr

- WBC >12,000 cell/mm3, <4,000 cells/mm3, or >10% immature (band) forms

Exclusion criteria:

- Ventricular assist devices, IABP, VAD, ECMO or any other mechanical cardiac support

Distributive Shock

Inclusion Criteria:

- Cardiopulmonary bypass for cardiac procedures within one hour of arriving in the ICU
post-op.

Exclusion Criteria:

- 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.

Exclusion Criteria:

- 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.

Decompensated Congestive Heart Failure

Inclusion Criteria:

- Patients presenting to VUMC with the diagnosis of congestive heart failure.

Exclusion Criteria:

- 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.

Atrial Fibrillation

Inclusion Criteria:

- Patients undergoing right heart catheterization in atrial fibrillation.

Exclusion Criteria:

- 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),
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.

High Risk Non-cardiac Surgery

Inclusion Criteria:

- Patients presenting for high-risk non-cardiac (major vascular, thoracic, or upper
abdominal) surgery.

Exclusion Criteria:

- 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, patients with known psychiatric or neurological disease who are unable to
consent, or any other medical condition which, in the opinion of the investigator,
would place the patient at undue risk from participation in the trial. Patients who do
not have a functional peripheral IV as part of standard care.

Healthy Volunteers

Inclusion Criteria:

- Subject age >21 years with ASA 1 or 2 status equivalent.

Exclusion Criteria:

- Any significant comorbidities or systemic illness. Inability to locate an appropriate
vein for cannulation by visual inspection; inability to obtain IV catheter within 3
attempts; Subject refusal at any time. Systolic blood pressure >160mmHg or <90 mmHg;
Diastolic blood pressure >100mmHg or <30mmHg; pulse rate >110 or <30 beats per minute;
respiratory rate>30 or <5 breaths per minute. Patients on medications for
hypertension, diabetes, or any vasoactive medication (phenylephrine/Sudafed/Afrin
nasal spray within 48 hours of study).