Dynamic Arterial Elastance Measured by Uncalibrated Pulse Contour Analysis Predicts Arterial Pressure Response to a Decrease in Norepinephrine (VESA)

September 27, 2018 updated by: Centre Hospitalier Universitaire, Amiens

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

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. We conducted a prospective study in a university hospital ICU. Patients with vasoplegic syndrome for whom the intensive care physician planned to decrease the norepinephrine dosage were included. Hemodynamic and uncalibrated pulse contour analysis (Volume view, FloTrac, Edwards Lifescience, Irvine) values were obtained before and after decreasing the norepinephrine dosage. Responders were defined by a >10% decrease in mean arterial pressure (MAP).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Observational

Enrollment (Actual)

35

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

one group Patients with vasoplegic syndrome

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 11, 2016

Primary Completion (Actual)

April 26, 2017

Study Completion (Actual)

April 26, 2017

Study Registration Dates

First Submitted

February 28, 2018

First Submitted That Met QC Criteria

February 28, 2018

First Posted (Actual)

March 7, 2018

Study Record Updates

Last Update Posted (Actual)

September 28, 2018

Last Update Submitted That Met QC Criteria

September 27, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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