Weaning of Norepinephrine Guided by the Dynamic Arterial Compliance in Cardiac Surgery Post Operative.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

130 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-10-31

Study Completion Date

2016-06-30

Brief Summary

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After cardiac surgery, vasoplegic syndrome is a hemodynamic state characterized by profound hypotension associated with a decrease in systemic vascular resistance. The care of this disease is based on the intravenous administration of a vasopressor, usually norepinephrine. During the recovery phase, weaning of norepinephrine, is an important step in which any lack of preload (blood volume) initial or secondary can be, and increase tissue malperfusion.

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Detailed Description

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Conditions

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Vasoplegic Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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administration of norepinephrine by dynamic elastance

The norepinephrine weaning strategy is based on an index that reflects the vasomotor tone: dynamic arterial elastance

Group Type EXPERIMENTAL

Norepinephrine

Intervention Type DRUG

Administration and weaning of norepinephrine is based on dynamic arterial elastance

control administration of norepinephrine

The usual procedure of withdrawal norepinephrine is based on hemodynamic parameters (blood pressure), clinical (cutaneous perfusion, mottling, hourly diuresis) and biological (SVO2, arterial lactate).

Group Type OTHER

Norepinephrine

Intervention Type DRUG

The usual procedure of withdrawal norepinephrine is based on hemodynamic parameters (blood pressure, cardiac output), clinical (cutaneous perfusion, mottling, hourly diuresis) and biological (SVO2, arterial lactate).

Interventions

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Norepinephrine

Administration and weaning of norepinephrine is based on dynamic arterial elastance

Intervention Type DRUG

Norepinephrine

The usual procedure of withdrawal norepinephrine is based on hemodynamic parameters (blood pressure, cardiac output), clinical (cutaneous perfusion, mottling, hourly diuresis) and biological (SVO2, arterial lactate).

Intervention Type DRUG

Other Intervention Names

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Dynamic arterial elastance Control

Eligibility Criteria

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Inclusion Criteria

* Major patient ≥ 18 years
* Patient operated a cardiac surgery for myocardial revascularization (CABG surgery) or surgical correction of valvular or combined surgery (CABG and valve disease) or surgery the ascending aorta and cardiac surgery with vasoplegic syndrome treated by norepinephrine
* Signed consent
* Affiliation to social assurance

Exclusion Criteria

* Permanent atrial fibrillation
* Treatment with dobutamine and/or epinephrine
* Pregnant woman
* Patient under guardianship or private public law
* Internal pacemaker
* Hypothermia
* Patient refusal

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No