NCT03455738

Brief Summary

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).

Trial Health

100
On Track

Trial Health Score

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

Enrollment
35

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2016

Shorter than P25 for all trials

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 11, 2016

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 26, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 26, 2017

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

February 28, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 7, 2018

Completed
Last Updated

September 28, 2018

Status Verified

September 1, 2018

Enrollment Period

7 months

First QC Date

February 28, 2018

Last Update Submit

September 27, 2018

Conditions

Keywords

Vasoplegia, norepinephrine, dynamic arterial elastance

Outcome Measures

Primary Outcomes (1)

  • Dynamic arterial elastance (Eadyn) defined as the ratio of PPV/SVV calculated from uncalibrated pulse contour analysis

    60 minutes

Interventions

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 norepineprhine dosage. Responders were defined by a \>10% decrease in mean arterial pressure (MAP).

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

one group Patients with vasoplegic syndrome

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Vasoplegia

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

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

Study Record Dates

First Submitted

February 28, 2018

First Posted

March 7, 2018

Study Start

October 11, 2016

Primary Completion

April 26, 2017

Study Completion

April 26, 2017

Last Updated

September 28, 2018

Record last verified: 2018-09