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

Centre Hospitalier Universitaire, Amiens

Status and phase: Completed; Phase 3

Conditions: Vasoplegic Syndrome

Treatments: Drug: Norepinephrine

Study type: Interventional

Funder types: Other

Identifiers

NCT02479529

2014-002707-22 (EudraCT Number)

PI2014_843_0014

Details and patient eligibility

About

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.

Enrollment: 130 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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130 participants in 2 patient groups

administration of norepinephrine by dynamic elastance

Experimental group

Description:

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

Treatment:

Drug: Norepinephrine

Drug: Norepinephrine

control administration of norepinephrine

Other group

Description:

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

Treatment:

Drug: Norepinephrine

Drug: Norepinephrine