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

C

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)

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

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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