InfectionPIVANCT03736421
Observational Study to Evaluate Peripheral IntraVenous Analysis (PIVA) in Euvolemic, Hypovolemic, and Hypervolemic Emergency Department Patients
An observational study of Infection and Hypervolemia, run by Beth Israel Deaconess Medical Center at 3 sites in United States.
Trial summary
The overall goal of this multicenter project is to characterize the expected normal range of Peripheral IntraVenous Volume Analysis (PIVA) values during a euvolemic state, and how those ranges may be altered by comorbidities; the relationship between PIVA and intravenous volume administration during resuscitation of… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Infection, Hypervolemia, Hypovolemia
- What is being tested?
- Peripheral Intravenous Analysis (PIVA), Non-invasive fluid response measure and Passive leg raise (PLR)
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 50 participants
- Where
- 3 sitesUnited States
- Study dates
- 10 Nov 2018to 1 Oct 2021
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Presumed Euvolemia cohort: This cohort is recruited to help to define what a "normal" PIVA value should be during a state of presumed euvolemia. Presumed Hypovolemia cohort: This is a cohort of patients with suspected infection and enriched with categories of sepsis patients. Hypervolemic cohort: This is a cohort of patients with a diagnosis of Congestive Heart Failure (CHF) who are being admitted to the hospital.
Who may be able to join
- Age > 18 years old
- Assessed as "euvolemic" by treating physician
- Age > 18 years old
- An accessible intravenous catheter is in place
- Known or suspected infection as assessed by the clinical team
- Intention to admit to the hospital
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- Anticipated administration of intravenous fluids per clinical team
- Age > 17 years old
- An accessible intravenous catheter is in place
- Primary clinical diagnosis of CHF
- Meet 2 of the three criterion:
- X-ray diagnosis
- Elevated bnp from known baseline
- Clinical diagnosis
- Received or intent to administer a diuretic agent
- Intent to admit to the hospital for anticipated > 24 hour period
Who cannot join
- History of any type of decreased oral intake or volume loss (e.g. diarrhea, vomiting, etc)
- History of a fever
- History of bleeding
- Any acute illness expected to alter volume
- Known or suspected pregnancy
- Active irregular heart rhythm
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- In the opinion of the treating physician, no anticipated intravenous fluid administration
- History of chronic or end stage renal disease
- Liver failure
- History of Acute heart failure
- Presence of abnormal vital signs (90 < HR < 60; 180 < SBP < 110, respiratory rate > 20, pulse ox < 92% or need for supplemental oxygen, 99.0 < temperature < 96).
- 2 additional group will be included in this euvolemic group
- Non-elderly patients (age < 50 year) without any comorbid illnesses and
- Age >65
- Diabetes on medications
- Hypertension on medications
- Vascular disease defined by history of peripheral vascular disease, stroke, MI
- Note: patients that receive >250 cc of IVF will be excluded from analysis.
- Infection Cohort (Presumed Hypovolemia)
- Clinical exam consistent with volume overload
- Known or suspected pregnancy
- Patients with a history of chronic renal insufficiency or end-stage renal disease
- Patients with a history of acute heart failure
- Acute Heart Failure (Hypervolemic cohort)
- History of any type of decreased oral intake or volume loss (e.g. diarrhea, vomiting, etc)
- History of a fever
- History of bleeding
- Known or suspected pregnancy
- Active irregular heart rhythm
- History of dialysis dependent end stage renal disease
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Beth Israel Medical Center
Boston, Massachusetts, 02215
University of Washington
Seattle, Washington, 98104
St. Vincent Hospital
Worcester, Massachusetts, 01608
About this study
The overall goal of this multicenter project is to characterize the expected normal range of Peripheral IntraVenous Volume Analysis (PIVA) values during a euvolemic state, and how those ranges may be altered by comorbidities; the relationship between PIVA and intravenous volume administration during resuscitation of infected patients with presumed hypovolemia; and, the relationship between PIVA and volume decreases during diuresis in acute heart failure patients with hypervolemia.
Read the detailed description
The determination of volume status remains a clinical challenge in medicine. Patients may develop hypovolemia (too little fluids in the vascular space) due to conditions such as hemorrhage, dehydration, or infection with vascular leak. Alternatively, patients may become hypervolemic (too much fluids in the vascular space), due to conditions such as heart failure, renal failure, or iatragenic over-resuscitation all of which overwhelm the kidney's ability to regulate intravascular volume status. In clinical practice, clinicians strive to return patients to euvolemia (the "right" volume status) through the administration of intravenous fluids or diuretics which remove fluids to achieve homeostasis. While there are a number of proposed clinical exam findings (e.g. dry mucous membranes or skin turgor), measurements (e.g. central venous pressure), or laboratory tests (e.g. blood urea nitrogen), none are precise or universally accepted as reliable methodologies to assess volume status.
The goal of this study is to perform a prospective observational study on three distinct cohorts during ED presentation to assess the variability and performance of PIVA in tracking volume status.
- Conditions
- Infection, Hypervolemia, Hypovolemia, Septic Shock, Acute Heart Failure, Congestive Heart Failure
- Being tested
- Peripheral Intravenous Analysis (PIVA), Non-invasive fluid response measure, Passive leg raise (PLR)
- Medical subject headings
- Infections, Edema, Hypovolemia, Shock, Septic, Heart Failure
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
Also called PIVA
Non-invasive measurement of peripheral intravenous waveform analysis (PIVA) obtained by connecting an Edwards standard transducer to a universal adaptor or stopcock on a peripheral IV
Non-invasive fluid response measureProcedure or surgery
To measure the stroke volume and changes in stroke volume in response to a passive leg raise (PLR) maneuver and fluid administration.
Passive leg raise (PLR)Diagnostic test
Also called PLR
Test to predict cardiac output and fluid responsiveness
| Study group | Role | What they receive |
|---|---|---|
| Control Cohort | This cohort is recruited to help to define what a "normal" PIVA value should be during a state of presumed euvolemia. Receives: Procedure: Peripheral Intravenous Analysis (PIVA); Diagnostic Test: Passive leg raise (PLR) | |
| Infection Cohort | This cohort are subjects with suspected infection, enriched to contain sepsis patients. Receives: Procedure: Peripheral Intravenous Analysis (PIVA); Procedure: Non-invasive fluid response measure; Diagnostic Test: Passive leg raise (PLR) | |
| Acute Heart Failure | This cohort will have a diagnosis of CFH who are being admitted to the hospital. These patients will be followed during their hospital course. Receives: Procedure: Peripheral Intravenous Analysis (PIVA); Procedure: Non-invasive fluid response measure; Diagnostic Test: Passive leg raise (PLR) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Association between PIVA measurement and fluid status (net gain vs net loss)
Change in fluid status over the first 6 hours as measured by weight and urine output and pressure status from the Edwards transducer
Measured: Baseline to 6 hours for euvolemic and hypovolemic cohort, and baseline to 72 hours for hypervolemic cohort
Secondary outcomes (2)
Response to Passive leg raise
Compute the change in PIVA measurement between before and after the passive leg raise challenge within each cohort
Measured: For the euvolemic cohort, baseline to 2 hours; For hypovolemic, cohort baseline to 6 hours; for the hypervolemic cohort, baseline up to 72 hours
Association between PIVA and non-invasive monitoring responsiveness to passive leg raise
Compare change in PIVA measurements to non-invasive monitoring measurements before and after passive leg raise and before and after fluid boluses
Measured: Baseline up to 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2018
- Study start10 Nov 2018
- Primary completion1 Oct 2021
- Study completion1 Oct 2021
Why it stopped: Enrollment and other trial activities have temporarily paused due to COVID-19 and are expected to resume in the future; This is not a suspension of IRB approval
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfectionStudies of the same condition, open and under way.
- More trials run by Beth Israel Deaconess 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
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beth Israel Deaconess Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Baxter Healthcare Corporation
- Responsible party
- Principal investigator, Nathan Shapiro, Beth Israel Deaconess Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03736421
- Sponsor's protocol ID
- 2018P000494
- Acronym
- PIVA
- Status last verified
- Oct 2024
- First submitted
- 29 Oct 2018
- Last updated
- 29 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- 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 29 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study to Evaluate Peripheral IntraVenous Analysis (PIVA) in Euvolemic, Hypovolemic, and Hypervolemic Emergency Department Patients
- ClinicalTrials.gov ID
- NCT03736421
- Acronym / sponsor ID
- PIVA / 2018P000494
- Conditions
- Infection, Hypervolemia, Hypovolemia, Septic Shock, Acute Heart Failure, Congestive Heart Failure
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Enrollment and other trial activities have temporarily paused due to COVID-19 and are expected to resume in the future; This is not a suspension of IRB approval
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Beth Israel Deaconess Medical CenterUniversity, hospital or other
- Collaborators
- Baxter Healthcare Corporation
- Study start
- 10 Nov 2018 (actual)
- Primary completion
- 1 Oct 2021 (actual)
- Study completion
- 1 Oct 2021 (actual)
- First posted
- 9 Nov 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 overall goal of this multicenter project is to characterize the expected normal range of Peripheral IntraVenous Volume Analysis (PIVA) values during a euvolemic state, and how those ranges may be altered by comorbidities; the relationship between PIVA and intravenous volume administration during resuscitation of infected patients with presumed hypovolemia; and, the relationship between PIVA and volume decreases during diuresis in acute heart failure patients with hypervolemia.
Detailed description
The determination of volume status remains a clinical challenge in medicine. Patients may develop hypovolemia (too little fluids in the vascular space) due to conditions such as hemorrhage, dehydration, or infection with vascular leak. Alternatively, patients may become hypervolemic (too much fluids in the vascular space), due to conditions such as heart failure, renal failure, or iatragenic over-resuscitation all of which overwhelm the kidney's ability to regulate intravascular volume status. In clinical practice, clinicians strive to return patients to euvolemia (the "right" volume status) through the administration of intravenous fluids or diuretics which remove fluids to achieve homeostasis. While there are a number of proposed clinical exam findings (e.g. dry mucous membranes or skin turgor), measurements (e.g. central venous pressure), or laboratory tests (e.g. blood urea nitrogen), none are precise or universally accepted as reliable methodologies to assess volume status.
The goal of this study is to perform a prospective observational study on three distinct cohorts during ED presentation to assess the variability and performance of PIVA in tracking volume status.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control Cohort | – | Procedure: Peripheral Intravenous Analysis (PIVA), Diagnostic Test: Passive leg raise (PLR)This cohort is recruited to help to define what a "normal" PIVA value should be during a state of presumed euvolemia. |
| Infection Cohort | – | Procedure: Peripheral Intravenous Analysis (PIVA), Procedure: Non-invasive fluid response measure, Diagnostic Test: Passive leg raise (PLR)This cohort are subjects with suspected infection, enriched to contain sepsis patients. |
| Acute Heart Failure | – | Procedure: Peripheral Intravenous Analysis (PIVA), Procedure: Non-invasive fluid response measure, Diagnostic Test: Passive leg raise (PLR)This cohort will have a diagnosis of CFH who are being admitted to the hospital. These patients will be followed during their hospital course. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Presumed Euvolemia cohort: This cohort is recruited to help to define what a "normal" PIVA value should be during a state of presumed euvolemia. Presumed Hypovolemia cohort: This is a cohort of patients with suspected infection and enriched with categories of sepsis patients. Hypervolemic cohort: This is a cohort of patients with a diagnosis of Congestive Heart Failure (CHF) who are being admitted to the hospital.
Key inclusion criteria (16 listed)
- Age > 18 years old
- Assessed as "euvolemic" by treating physician
- Age > 18 years old
- An accessible intravenous catheter is in place
- Known or suspected infection as assessed by the clinical team
Key exclusion criteria (30 listed)
- History of any type of decreased oral intake or volume loss (e.g. diarrhea, vomiting, etc)
- History of a fever
- History of bleeding
- Any acute illness expected to alter volume
- Known or suspected pregnancy
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)Also: PIVANon-invasive measurement of peripheral intravenous waveform analysis (PIVA) obtained by connecting an Edwards standard transducer to a universal adaptor or stopcock on a peripheral IV | Procedure or surgery | Acute Heart Failure, Control Cohort, Infection Cohort |
| Non-invasive fluid response measureTo measure the stroke volume and changes in stroke volume in response to a passive leg raise (PLR) maneuver and fluid administration. | Procedure or surgery | Acute Heart Failure, Infection Cohort |
| Passive leg raise (PLR)Also: PLRTest to predict cardiac output and fluid responsiveness | Diagnostic test | Acute Heart Failure, Control Cohort, Infection Cohort |
Primary outcome
Association between PIVA measurement and fluid status (net gain vs net loss)
Time frame: Baseline to 6 hours for euvolemic and hypovolemic cohort, and baseline to 72 hours for hypervolemic cohort
Change in fluid status over the first 6 hours as measured by weight and urine output and pressure status from the Edwards transducer
2 secondary outcomes
Response to Passive leg raise
Time frame: For the euvolemic cohort, baseline to 2 hours; For hypovolemic, cohort baseline to 6 hours; for the hypervolemic cohort, baseline up to 72 hours
Association between PIVA and non-invasive monitoring responsiveness to passive leg raise
Time frame: Baseline up to 72 hours
Results and safety
The study was stopped early (reason given: Enrollment and other trial activities have temporarily paused due to COVID-19 and are expected to resume in the future; This is not a suspension of IRB approval). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2024.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infection and Hypervolemia, run by Beth Israel Deaconess Medical Center at 3 sites 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 16 inclusion and 30 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 29 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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: Enrollment and other trial activities have temporarily paused due to COVID-19 and are expected to resume in the future; This is not a suspension of IRB approval). 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?
Association between PIVA measurement and fluid status (net gain vs net loss) (time frame: Baseline to 6 hours for euvolemic and hypovolemic cohort, and baseline to 72 hours for hypervolemic cohort). 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 29 Oct 2024.