Prospective StudiesNCT03526497
Correlation Between Peripheral Venous Pressure and Central Venous Pressure in the Cardiac Intensive Care Unit
An observational study of Prospective Studies and Heart Failure, run by The Cleveland Clinic at 1 site in United States.
Trial 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? Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Prospective Studies, Heart Failure
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Apr 2018to 29 Mar 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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?
Read the 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.
- 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
- Medical subject headings
- Heart Failure, Acute Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
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?
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.
Measured: 7-14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2018
- Study start4 Apr 2018
- Primary completion29 Mar 2022
- Study completion29 Mar 2022
Why it stopped: Poor enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prospective StudiesStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mazen Hanna, MD, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03526497
- Sponsor's protocol ID
- 18-325
- Status last verified
- Jan 2023
- First submitted
- 5 Apr 2018
- Last updated
- 27 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Between Peripheral Venous Pressure and Central Venous Pressure in the Cardiac Intensive Care Unit
- ClinicalTrials.gov ID
- NCT03526497
- Acronym / sponsor ID
- 18-325
- Conditions
- Prospective Studies, Heart Failure
- Keywords
- Catheterization, Peripheral/methods, Humans, Acute Disease, Aged, Female, Male, Follow-Up Studies, Heart Failure/physiopathology
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Poor enrollment
- Enrolment
- 9 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Study start
- 4 Apr 2018 (actual)
- Primary completion
- 29 Mar 2022 (actual)
- Study completion
- 29 Mar 2022 (actual)
- First posted
- 16 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
The study was stopped early (reason given: Poor enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mazen Hanna, MD principal investigator
The Cleveland Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prospective Studies and Heart Failure, run by The Cleveland Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 27 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Poor enrollment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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? (time frame: 7-14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2023.