Peripheral Venous Pressure (PVP) Trial
ConditionCongestive Heart Failure
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorWake Forest University Health Sciences
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients with minimum 3-month history of Congestive Heart Failure admitted to Aurora St. Luke's Medical Center with acute decompensation
English speaking only
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
peripheral venous pressure measurements
Other interventionPeripheral 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.
standard clinical care
Other interventionUsual standard clinical care
Treatment groups
600 Participants
are divided into 2 treatment groupsGroup A: peripheral venous pressure measurementsExperimental treatment 1 intervention
Group B: standard clinical careActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Length of hospital stay
Number of days from admission to discharge
Time frame
up to day 82
Number of subjects rehospitalized
Number of subjects in each group who have been rehospitalized
Time frame
Day 30 post index hospitalization3
Number of subjects rehospitalized
Number of subjects in each group who have been rehospitalized
Time frame
Month 6 post index hospitalizationSecondary outcomes
1
Number of subjects with exertional dyspnea
Number of subjects in each group experiencing dyspnea according to the New York Heart Association Class
Time frame
Day 1 and date of discharge (up to day 8)2
Number of subjects with exertional orthopnea
Number of subjects in each group experiencing orthopnea according to the New York Heart Association Class
Time frame
Day 1 and date of discharge (up to day 8)3
Number of subjects with new need for dialysis during index hospitalization
Number of subjects in each group with new need for dialysis during index hospitalization
Time frame
Day 1 and date of discharge (up to day 8)4
Number of subjects with diuretic use
Number of subjects in each group with diuretic use during index hospitalization
Time frame
Day 1 and date of discharge (up to day 8)Sponsors and contacts
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Source ClinicalTrials.gov