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

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ClinicalTrials.gov Identifier: NCT02479529
Recruitment Status : Completed
First Posted : June 24, 2015
Last Update Posted : October 21, 2016
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire, Amiens

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Vasoplegic Syndrome Drug: Norepinephrine Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 130 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Weaning of Norepinephrine Guided by the Dynamic Arterial Compliance in Cardiac Surgery Post Operative.
Study Start Date : October 2014
Actual Primary Completion Date : June 2016
Actual Study Completion Date : June 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Surgery

Arm Intervention/treatment
Experimental: administration of norepinephrine by dynamic elastance
The norepinephrine weaning strategy is based on an index that reflects the vasomotor tone: dynamic arterial elastance
Drug: Norepinephrine
Administration and weaning of norepinephrine is based on dynamic arterial elastance
Other Name: 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).
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).
Other Name: Control




Primary Outcome Measures :
  1. The duration of treatment with norepinephrine. [ Time Frame: Day 28 ]
    Mean duration time of norepinephrine administration calculated in hours


Secondary Outcome Measures :
  1. The total dose of norepinephrine infused during the study period [ Time Frame: Day 28 ]
  2. ICU duration of stay in day [ Time Frame: Day 28 ]
  3. Total urine output in ml during the study period [ Time Frame: Day 28 ]
  4. Total of crystalloid an colloid infused during the study period (ml) [ Time Frame: Day 28 ]
  5. the rate of arterial lactate at the end of norepinephrine administration [ Time Frame: Day 28 ]
  6. Incidence of postoperative atrial arrhythmias (Ac/Fa, Ventricular tachycardia, Ventricular flutter, Ventricular fibrillation) during the study period [ Time Frame: Day 28 ]
  7. SOFA score [ Time Frame: Day 28 ]
    SOFA score measured at the end of norepinephrine administration



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02479529


Locations
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France
CHU Amiens-Picardie
Amiens, Picardie, France, 80054
Sponsors and Collaborators
Centre Hospitalier Universitaire, Amiens
Investigators
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Principal Investigator: Pierre-Grégoire Guinot, Doctor CHU Amiens-Picardie
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Centre Hospitalier Universitaire, Amiens
ClinicalTrials.gov Identifier: NCT02479529    
Other Study ID Numbers: PI2014_843_0014
2014-002707-22 ( EudraCT Number )
First Posted: June 24, 2015    Key Record Dates
Last Update Posted: October 21, 2016
Last Verified: October 2016
Additional relevant MeSH terms:
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Vasoplegia
Vascular Diseases
Cardiovascular Diseases
Postoperative Complications
Pathologic Processes
Norepinephrine
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Vasoconstrictor Agents