- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03455738
Dynamic Arterial Elastance Measured by Uncalibrated Pulse Contour Analysis Predicts Arterial Pressure Response to a Decrease in Norepinephrine (VESA)
Dynamic Arterial Elastance Measured by Uncalibrated Pulse Contour Analysis Predicts Arterial Pressure Response to a Decrease in Norepinephrine (VESA) Dynamic Arterial Elastance Measured by Uncalibrated Pulse Contour Analysis
Study Overview
Detailed Description
- Background : Dynamic arterial elastance (Eadyn) has been proposed as an indicator of arterial tone that can predict norepinephrine-dependent arterial pressure. Eadyn is calculated using the ratio of respiratory pulse pressure variation (PPV) over the respiratory stroke volume variation (SVV). Guinot et al demonstrated a decrease in the duration of norepinephrine treatment with the use of Eadyn. To date, studies that have validated Eadyn at bedside have used cardiac output (CO) calibrated pulse contour analysis (PiCCO™, Pulsion™) or oesophageal doppler. Such monitoring systems need dedicated and specific arterial line and venous access that may limit their use at bedside. In addition to CO calibrated pulse contour analysis, CO uncalibrated pulse contour analysis has been developed and is considered less invasive. Nevertheless, one limitation of the latter CO monitoring is inaccuracy of CO measurement in patients who are being treated with norepinephrine. These limitations may affect the predictability of Eadyn.
- Purpose : To date, no study has evaluated the ability of Eadyn measured by uncalibrated pulse contour analysis to assess arterial pressure response to a decreased dose of norepinephrine. We tested the hypothesis that Eadyn calculated from uncalibrated pulse contour analysis predicts the arterial-pressure response to a norepinephrine decrease in patients treated with norepinephrine
Study Type
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
Inclusion criteria were all consecutive patients with a diagnosis of vasoplegic syndrome, treated with norepinephrine, for whom the attending physician decided to decrease the norepinephrine dosage. The vasoplegic syndrome was defined as persistent arterial hypotension with normal or high cardiac output and low systemic vascular resistance
Exclusion Criteria:
Exclusion criteria were patients treated with epinephrine and/or dobutamine, arrhythmia, intra-abdominal hypertension and patients younger than 18 years.
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Dynamic arterial elastance (Eadyn) defined as the ratio of PPV/SVV calculated from uncalibrated pulse contour analysis
Time Frame: 60 minutes
|
60 minutes
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RNI2016-28
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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