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

NCT ID: NCT03526497

Last Updated: 2023-01-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Total Enrollment

9 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-04-04

Study Completion Date

2022-03-29

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Prospective Studies Heart Failure

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

The Cleveland Clinic

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Mazen Hanna, MD

Role: PRINCIPAL_INVESTIGATOR

The Cleveland Clinic

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Cleveland Clinic

Cleveland, Ohio, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

18-325

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.