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

• ClinicalTrials.gov Identifier: NCT03526497
• Recruitment Status: Recruiting
• First Posted: May 16, 2018
• Last Update Posted: January 27, 2022
• Sponsor: The Cleveland Clinic
• Information provided by (Responsible Party): Mazen Hanna MD, The Cleveland Clinic

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
Prospective Studies; Heart Failure

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
• Estimated 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: April 4, 2018
• Estimated Primary Completion Date: December 2023
• Estimated Study Completion Date: December 2023

Groups and Cohorts

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? [ Time Frame: 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

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• 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.

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.

Contacts and Locations

Contacts

Contact: Mazen Hanna, MD; 216-444-3490; Hannam@ccf.org

Locations

United States, Ohio

Cleveland Clinic; Recruiting

Cleveland, Ohio, United States, 44195

Contact: Mazen Hanna, MD 216-444-3490 Hannam@ccf.org

Sponsors and Collaborators

The Cleveland Clinic

Investigators

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

More Information

• 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: January 27, 2022
• Last Verified: January 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, The Cleveland Clinic:

Catheterization, Peripheral/methods; Humans; Acute Disease; Aged; Female; Male; Follow-Up Studies; Heart Failure/physiopathology; Prospective Studies; Stroke Volume/physiology; Venous Pressure/physiology

Additional relevant MeSH terms:

Heart Failure; Heart Diseases; Cardiovascular Diseases