Systemic Inflammatory Response SyndromePIVANCT03407287
Peripheral Venous Analysis (PIVA) for Predicting Volume Responsiveness and Fluid Status
An observational study of Systemic Inflammatory Response Syndrome and Distributive Shock, run by Vanderbilt University Medical Center at 1 site in United States.
Trial 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 Intravenous waveform Analysis (PIVA) signal. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Systemic Inflammatory Response Syndrome, Distributive Shock, Hypotension and Shock
- What is being tested?
- Peripheral Intravenous Analysis (PIVA) and Standard noninvasive vascular monitoring
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 180 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Jan 2018to 1 Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study will enroll patients hospitalized at Vanderbilt University Medical Center.
Who may be able to join
- Patients undergoing right heart catheterization or left and right heart catheterizaton; Age >=18
- Cardiopulmonary bypass for cardiac procedures within one hour of arriving in the ICU post-op; Age >=18
- Hospitalized patients with central venous access and pulmonary arterial catheter in place, requiring infusion of vasoactive and/or inotropic agents; Age >=18
- Patients presenting to Vanderbilt University Medical Center with the diagnosis of congestive heart failure and present with symptoms of fluid overload; Age>=18
- Patients with atrial fibrillation undergoing direct current cardioversion; Age >=18
- Patients presenting for surgery requiring positive pressure ventilation and arterial line placement; Age >=18
Who cannot join
- 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
- 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
- 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.
- Congestive Heart Failure
Show all 11Show fewer
- Cardiac assist devices (intra-aortic balloon pump, ventricular assist devices, and extra corporeal membrane oxygenation), ongoing ACLS, active irregular heart rhythm, patient with restrictive cardiomyopathies (cardiac amyloidosis), or 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.
- Atrial Fibrillation (undergoing elective direct current cardio version)
- Cardiac assist devices (intra-aortic balloon pump, ventricular assist devices, and extra corporeal membrane oxygenation), ongoing ACLS, patients with restrictive cardiomyopathies (cardiac amyloidosis) or 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.
- Patients undergoing Surgery
- Cardiac assist devices (intra-aortic balloon pump, ventricular assist devices, and extra corporeal membrane oxygenation), ongoing ACLS, patients with restrictive cardiomyopathies (cardiac amyloidosis) or constrictive cardiac disease (constrictive pericarditis or cardiac tamponade), active irregular cardiac rhythm, congenital heart disease other than foramen ovale , repaired atrial or ventricular septal defect, 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Medical Center
Nashville, Tennessee, 37212
About this study
Official title: Peripheral Venous Analysis (PIVA) for Predicting Volume Responsiveness and Fluid Status:
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 Intravenous waveform Analysis (PIVA) signal.
Read the 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. 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
- Conditions
- Systemic Inflammatory Response Syndrome, Distributive Shock, Hypotension and Shock, Decompensated Congestive Heart Failure, Atrial Fibrillation, High Risk Non-cardiac Surgery
- Being tested
- Peripheral Intravenous Analysis (PIVA), Standard of care invasive vascular monitoring, Standard noninvasive vascular monitoring
- Medical subject headings
- Systemic Inflammatory Response Syndrome, Hypotension, Shock, Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peripheral Intravenous Analysis (PIVA)Procedure or surgery
Non-invasive measurement of peripheral venous waveform analysis (PIVA) obtained by connecting a standard transducer (AD Instruments, Colorado Springs, Co) to a universal adaptor or stopcock on a peripheral IV
Standard of care invasive vascular monitoringProcedure or surgery
Standard of care invasive monitoring in the intensive care settings with central venous catheters, pulmonary artery catheters, or trans-esophageal echocardiography for determining volume status.
Standard noninvasive vascular monitoringProcedure or surgery
Standard noninvasive vascular monitoring of blood pressure, pulse rate, pulse oximetry and respiratory rate.
| Study group | Role | What they receive |
|---|---|---|
| Cardiac Catheterization | Not described Receives: Procedure: Peripheral Intravenous Analysis (PIVA); Procedure: Standard of care invasive vascular monitoring; Procedure: Standard noninvasive vascular monitoring | |
| Distributive shock | Not described Receives: Procedure: Peripheral Intravenous Analysis (PIVA); Procedure: Standard of care invasive vascular monitoring; Procedure: Standard noninvasive vascular monitoring | |
| Vasoactive and inotropic agents | Not described Receives: Procedure: Peripheral Intravenous Analysis (PIVA); Procedure: Standard of care invasive vascular monitoring; Procedure: Standard noninvasive vascular monitoring | |
| Congestive heart failure | Not described Receives: Procedure: Peripheral Intravenous Analysis (PIVA); Procedure: Standard of care invasive vascular monitoring; Procedure: Standard noninvasive vascular monitoring | |
| Atrial fibrillation | Patients with atrial fibrillation undergoing elective direct current cardioversion Receives: Procedure: Peripheral Intravenous Analysis (PIVA); Procedure: Standard of care invasive vascular monitoring; Procedure: Standard noninvasive vascular monitoring | |
| Patients undergoing surgery | Patients undergoing surgery requiring positive pressure ventilation and arterial line placement Receives: Procedure: Peripheral Intravenous Analysis (PIVA); Procedure: Standard of care invasive vascular monitoring; Procedure: Standard noninvasive vascular monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation of PIVA score to standard hemodynamic monitors
Peripheral intravenous waveform analysis score is used to detect intravascular volume status. The scale ranges from 2-40 and is interpreted as a surrogate for pulmonary capillary wedge pressure. The normal scale range is 6-12. A PIVA score of 2 indicates a low intravascular volume and 40 indicates a high intravascular volume.
Measured: Baseline to end of monitoring (Approximately 180 minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2018
- Study start8 Jan 2018
- Primary completion1 Dec 2020
- Study completion1 Dec 2020
Why it stopped: interim analysis, closed for additional product development
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic Inflammatory Response SyndromeStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Baxter Healthcare Corporation
- Responsible party
- Principal investigator, Kelly Kohorst, Vanderbilt University Medical Center
- Investigators
- Kelly L. Kohorst, MD, Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03407287
- Sponsor's protocol ID
- 828397
- Acronym
- PIVA
- Status last verified
- Apr 2021
- First submitted
- 16 Jan 2018
- Last updated
- 12 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peripheral Venous Analysis (PIVA) for Predicting Volume Responsiveness and Fluid Status:
- ClinicalTrials.gov ID
- NCT03407287
- Acronym / sponsor ID
- PIVA / 828397
- Conditions
- Systemic Inflammatory Response Syndrome, Distributive Shock, Hypotension and Shock, Decompensated Congestive Heart Failure, Atrial Fibrillation, High Risk Non-cardiac Surgery
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: interim analysis, closed for additional product development
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Collaborators
- Baxter Healthcare Corporation
- Study start
- 8 Jan 2018 (actual)
- Primary completion
- 1 Dec 2020 (actual)
- Study completion
- 1 Dec 2020 (actual)
- First posted
- 23 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 Intravenous waveform Analysis (PIVA) signal.
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. 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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Cardiac Catheterization | – | Procedure: Peripheral Intravenous Analysis (PIVA), Procedure: Standard of care invasive vascular monitoring, Procedure: Standard noninvasive vascular monitoring |
| Distributive shock | – | Procedure: Peripheral Intravenous Analysis (PIVA), Procedure: Standard of care invasive vascular monitoring, Procedure: Standard noninvasive vascular monitoring |
| Vasoactive and inotropic agents | – | Procedure: Peripheral Intravenous Analysis (PIVA), Procedure: Standard of care invasive vascular monitoring, Procedure: Standard noninvasive vascular monitoring |
| Congestive heart failure | – | Procedure: Peripheral Intravenous Analysis (PIVA), Procedure: Standard of care invasive vascular monitoring, Procedure: Standard noninvasive vascular monitoring |
| Atrial fibrillation | – | Procedure: Peripheral Intravenous Analysis (PIVA), Procedure: Standard of care invasive vascular monitoring, Procedure: Standard noninvasive vascular monitoringPatients with atrial fibrillation undergoing elective direct current cardioversion |
| Patients undergoing surgery | – | Procedure: Peripheral Intravenous Analysis (PIVA), Procedure: Standard of care invasive vascular monitoring, Procedure: Standard noninvasive vascular monitoringPatients undergoing surgery requiring positive pressure ventilation and arterial line placement |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study will enroll patients hospitalized at Vanderbilt University Medical Center.
Key inclusion criteria (6 listed)
- Patients undergoing right heart catheterization or left and right heart catheterizaton; Age >=18
- Cardiopulmonary bypass for cardiac procedures within one hour of arriving in the ICU post-op; Age >=18
- Hospitalized patients with central venous access and pulmonary arterial catheter in place, requiring infusion of vasoactive and/or inotropic agents; Age >=18
- Patients presenting to Vanderbilt University Medical Center with the diagnosis of congestive heart failure and present with symptoms of fluid overload; Age>=18
- Patients with atrial fibrillation undergoing direct current cardioversion; Age >=18
Key exclusion criteria (11 listed)
- 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
- 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
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Peripheral Intravenous Analysis (PIVA)Non-invasive measurement of peripheral venous waveform analysis (PIVA) obtained by connecting a standard transducer (AD Instruments, Colorado Springs, Co) to a universal adaptor or stopcock on a peripheral IV | Procedure or surgery | Atrial fibrillation, Cardiac Catheterization, Congestive heart failure, Distributive shock, Patients undergoing surgery, Vasoactive and inotropic agents |
| Standard of care invasive vascular monitoringStandard of care invasive monitoring in the intensive care settings with central venous catheters, pulmonary artery catheters, or trans-esophageal echocardiography for determining volume status. | Procedure or surgery | Atrial fibrillation, Cardiac Catheterization, Congestive heart failure, Distributive shock, Patients undergoing surgery, Vasoactive and inotropic agents |
| Standard noninvasive vascular monitoringStandard noninvasive vascular monitoring of blood pressure, pulse rate, pulse oximetry and respiratory rate. | Procedure or surgery | Atrial fibrillation, Cardiac Catheterization, Congestive heart failure, Distributive shock, Patients undergoing surgery, Vasoactive and inotropic agents |
Primary outcome
Correlation of PIVA score to standard hemodynamic monitors
Time frame: Baseline to end of monitoring (Approximately 180 minutes)
Peripheral intravenous waveform analysis score is used to detect intravascular volume status. The scale ranges from 2-40 and is interpreted as a surrogate for pulmonary capillary wedge pressure. The normal scale range is 6-12. A PIVA score of 2 indicates a low intravascular volume and 40 indicates a high intravascular volume.
Results and safety
The study was stopped early (reason given: interim analysis, closed for additional product development). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kelly L. Kohorst, MD principal investigator
Vanderbilt University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Systemic Inflammatory Response Syndrome and Distributive Shock, run by Vanderbilt University Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 12 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: interim analysis, closed for additional product development). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation of PIVA score to standard hemodynamic monitors (time frame: Baseline to end of monitoring (Approximately 180 minutes)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2021.