Clinical trial NCT03526497: Correlation Between Peripheral Venous Pressure and Central Venous Pressure in the Cardiac Intensive Care Unit
Official title: Correlation Between Peripheral Venous Pressure and Central Venous Pressure in the Cardiac Intensive Care Unit
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Prospective Studies
Heart Failure
Keywords: Catheterization, Peripheral/methods
Humans
Acute Disease
Aged
Female
Male
Follow-Up Studies
Heart Failure/physiopathology
Prospective Studies
Stroke Volume/physiology
Venous Pressure/physiology
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
First posted: 2018-05-16
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients with pulmonary artery catheters and peripheral IVs admitted to the Coronary Care Units at the Cleveland Clinic, meeting the inclusion criteria, will be considered for enrollment.

Brief summary: In patients admitted to a coronary care unit, what is the correlation coefficient and limits of agreement for paired measurements of peripheral venous pressure and central venous pressure at multiple time points during the patient's hospitalization?

Detailed description: The treatment of numerous cardiac conditions requires assessment of intravascular volume status, using central venous pressure (CVP) as the gold standard. Measurement of CVP requires placement of an invasive venous catheter, with insertion of a venous catheter into a central vein to obtain CVP. Catheter placement is invasive, costly and not without complications. Ideally, there would exist a peripheral surrogate for CVP that would be 1) minimally invasive to obtain, 2) low cost and 3) strongly correlate with CVP over a wide range of physiological conditions.

The peripheral venous system is in continuity with the central venous system and, as such, would be expected to have a pressure that correlates with central venous pressure. Numerous previous studies suggest a correlation between peripheral venous pressure (PVP) and central venous pressure. Prior studies have demonstrated a reasonable correlation between CVP and PVP in patient populations including decompensated heart failure, cardiac and non-cardiac surgery(1), liver transplant donors(2) and recipients(3), neurosurgical(4) and pediatric patients.(5) In an earlier study published by the authors of this paper, the mean difference between PVP and CVP in patients with acute heart failure syndromes was 0.4 mmHg with a correlation coefficient of 0.947. One limitation of the earlier study was that it established this correlation at only one point in time. In the study presented here, PVP and CVP will be obtained and correlation will be assessed across multiple time points during a given patient's hospitalization.

This is a prospective, single center cohort study to investigate the correlation between peripheral venous pressure and central venous pressure.

Eligibility criteria: Inclusion Criteria:

* We plan to enroll patients who meet the following criteria: Patients admitted to an intensive care unit for invasive hemodynamic monitoring. All eligible patients will be those who have already undergone pulmonary artery catheterization via the internal jugular or subclavian veins and upper extremity peripheral IV placement per routine standard of care prior to enrollment.

Exclusion Criteria:

* Patients will be excluded from this study for the following reasons: age less than 18 years of age, inability to obtain consent, femoral pulmonary artery catheter, or if their attending physician refuses to allow enrollment.

Primary outcomes:
measure: In patients admitted to a coronary care unit, what is the correlation coefficient and limits of agreement for paired measurements of PVP and CVP at multiple time points during the patient's hospitalization?
timeFrame: 7-14 days
Secondary outcomes:
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
Study officials:
affiliation: The Cleveland Clinic
name: Mazen Hanna, MD
role: PRINCIPAL_INVESTIGATOR
References: