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Completed

NCT Number: NCT02479529

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

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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Key information

Conditions

Vasoplegic Syndrome Cardiovascular Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Vascular Diseases Vasoplegia

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

CHU Amiens-Picardie

Amiens, Picardie, 80054, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

norepinephrine

Drug

Administration and weaning of norepinephrine is based on dynamic arterial elastance

Other names: Dynamic arterial elastance

Primary outcomes

  1. The duration of treatment with norepinephrine.

    Time frame: Day 28

    Mean duration time of norepinephrine administration calculated in hours

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire, Amiens

Other

Registry information

Acronym: SNEAD

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Jun 24, 2015
Registry last updated
Sep 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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