Peripheral Venous Pressure (PVP) Trial

Official title

Reducing the Length of Stay and Incidence of Rehospitalization in Heart Failure Patients by Measuring Peripheral Venous Pressure; a Randomized Clinical Trial

Overview

The purpose of the study is to determine if there is a reduction in the length of stay and rates of rehospitalization for patients diagnosed with congestive heart failure when physicians are provided daily measurements of peripheral venous pressure versus no daily measurements of peripheral venous pressure.

Detailed description

The objective of the study is to evaluate the effectiveness of standard clinical care versus standard clinical care directed by peripheral venous pressure on length of hospital stay and incidence of rehospitalization among heart failure patients.

The study team hypothesizes that compared to standard clinical care the peripheral venous pressure-guided therapy is associated with shorter hospital stay and lesser incidence of 30-day rehospitalization. The study team will also collect data to determine if peripheral venous pressure-guided care is associated with reduced incidence of 6-month rehospitalization, improvement in symptoms or lab indices, lesser new incidence of dialysis, change in use of diuretics, and lesser use of echocardiograms.

Interventions

• Other peripheral venous pressure measurements
  Peripheral venous pressure measures provided to physicians daily up to 8 days, with a research note in the electronic medical record containing standardized recommendations for case also provided daily. Care changes up to clinical provider discretion.
• Other standard clinical care
  Usual standard clinical care

Primary outcome measures

• Length of hospital stay [Time frame: up to day 8]
• Number of subjects rehospitalized [Time frame: Day 30 post index hospitalization]
• Number of subjects rehospitalized [Time frame: Month 6 post index hospitalization]

Secondary outcome measures (7)

• Number of subjects with exertional dyspnea [Time frame: Day 1 and date of discharge (up to day 8)]
• Number of subjects with exertional orthopnea [Time frame: Day 1 and date of discharge (up to day 8)]
• Number of subjects with new need for dialysis during index hospitalization [Time frame: Day 1 and date of discharge (up to day 8)]
• Number of subjects with diuretic use [Time frame: Day 1 and date of discharge (up to day 8)]
• Number of subjects with echocardiograms [Time frame: Day 1 and date of discharge (up to day 8)]
• Number of subjects with all-cause death [Time frame: Month 6 post index hospitalization]
• Number of subjects with cardiac-related death [Time frame: Month 6 post index hospitalization]

Eligibility criteria

Inclusion criteria

• Patients with minimum 3-month history of Congestive Heart Failure admitted to Aurora St. Luke's Medical Center with acute decompensation
• English speaking only

Exclusion criteria

• Patients who do not already have a peripheral IV line inserted
• Patients whose IV line cannot be transduced
• Patients with current or past vein thrombosis in the arm used to measure the pressure or with history of recurrent (>1) pulmonary embolism
• Patients with active thrombophlebitis in the arm
• Patients who have experienced a major cardiovascular event (myocardial infarction, stroke, etc.) ≤2 months prior to the admission date
• Patients who have received an implanted cardiac resynchronization device (pacemaker or ICD) ≤3 months prior to admission date
• Patients enrolled in other cardiovascular research studies.
• Patients with a clinical condition that the investigator believes may not allow the patient to complete the study, at the discretion of the investigator. Examples of conditions that may apply include severe stenotic valvular disease, isolated right ventricle failure, precapillary pulmonary hypertension, hypertrophic obstructive cardiomyopathy, implanted left ventricular assist device, history of heart transplantation, clinical diagnosis of cardiogenic shock, any left-to-right shunt
• Patients with congenital heart disease or mechanical right heart valve(s)
• Planned heart surgery and/or coronary intervention during hospitalization
• Patients expected to receive heart transplant within 6 months of admission
• IV cannula smaller than 22G
• Patients who are pregnant and/or lactating
• Patients who are unable to provide informed consent
• Patients who are intubated

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

United States · 1 center

• Aurora St. Luke's Medical Center — Milwaukee

Identifiers

NCT: NCT07400042 · IRB00142526

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗