NCT03526497

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?

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 4, 2018

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

April 5, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 16, 2018

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 29, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 29, 2022

Completed
Last Updated

January 27, 2023

Status Verified

January 1, 2023

Enrollment Period

4 years

First QC Date

April 5, 2018

Last Update Submit

January 26, 2023

Conditions

Keywords

Catheterization, Peripheral/methodsHumansAcute DiseaseAgedFemaleMaleFollow-Up StudiesHeart Failure/physiopathologyProspective StudiesStroke Volume/physiologyVenous Pressure/physiology

Outcome Measures

Primary Outcomes (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?

    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.

    7-14 days

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Heart FailureAcute Disease

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Mazen Hanna, MD

    The Cleveland Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 5, 2018

First Posted

May 16, 2018

Study Start

April 4, 2018

Primary Completion

March 29, 2022

Study Completion

March 29, 2022

Last Updated

January 27, 2023

Record last verified: 2023-01

Locations