Correlation Between Peripheral Venous Pressure and Central Venous Pressure in the Cardiac Intensive Care Unit

Sponsor
The Cleveland Clinic (Other)
Overall Status
Recruiting
CT.gov ID
NCT03526497
Collaborator
(none)
30
1
67.9
0.4

Study Details

Study Description

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?

Condition or Disease Intervention/Treatment Phase

    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.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    30 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Correlation Between Peripheral Venous Pressure and Central Venous Pressure in the Cardiac Intensive Care Unit
    Actual Study Start Date :
    Apr 4, 2018
    Anticipated Primary Completion Date :
    Dec 1, 2023
    Anticipated Study Completion Date :
    Dec 1, 2023

    Outcome Measures

    Primary Outcome Measures

    1. 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? [7-14 days]

      Peripheral Venous Pressure and Central Venous pressure will be measured at three time points across a patient's hospitalization. The correlation coefficient and limits of agreement for paired measurements will be calculated.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Cleveland Clinic Cleveland Ohio United States 44195

    Sponsors and Collaborators

    • The Cleveland Clinic

    Investigators

    • Principal Investigator: Mazen Hanna, MD, The Cleveland Clinic

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Mazen Hanna MD, Prinicipal Investigator, The Cleveland Clinic
    ClinicalTrials.gov Identifier:
    NCT03526497
    Other Study ID Numbers:
    • 18-325
    First Posted:
    May 16, 2018
    Last Update Posted:
    Jan 27, 2022
    Last Verified:
    Jan 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Mazen Hanna MD, Prinicipal Investigator, The Cleveland Clinic
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jan 27, 2022