Observational Study to Evaluate Peripheral IntraVenous Analysis (PIVA) in Euvolemic, Hypovolemic,… (NCT03736421) | Clinical Trial Compass
TerminatedNot Applicable
Observational Study to Evaluate Peripheral IntraVenous Analysis (PIVA) in Euvolemic, Hypovolemic, and Hypervolemic Emergency Department Patients
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
United States50 participantsStarted 2018-11-10
Plain-language 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 infected patients with presumed hypovolemia; and, the relationship between PIVA and volume decreases during diuresis in acute heart failure patients with hypervolemia.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Control Cohort (Presumed Euvolemia)
Inclusion Criteria:
* Age \> 18 years old
* Assessed as "euvolemic" by treating physician
Exclusion Criteria:
* 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
* 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)
Inclusion Criteria:
* 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
* Anticipated administration of intravenous fluids per clinical team
Exclusion Criteria:
* Clinical exam consistent with volume overload
* Known …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Association between PIVA measurement and fluid status (net gain vs net loss)
Timeframe: Baseline to 6 hours for euvolemic and hypovolemic cohort, and baseline to 72 hours for hypervolemic cohort