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

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.

Study Overview

• Status: Completed
• Conditions: Vasoplegic Syndrome
• Intervention / Treatment: Drug: Norepinephrine; Drug: Norepinephrine

• Study Type: Interventional
• Enrollment (Actual): 130
• Phase: Phase 3

Contacts and Locations

Study Locations

• France
  • Picardie
    • Amiens, Picardie, France, 80054
      • CHU Amiens-Picardie

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: Dynamic arterial elastance; 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 Names: Control
Other: 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; Administration and weaning of norepinephrine is based on dynamic arterial elastance; Other Names: Dynamic arterial elastance; 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 Names: Control

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The duration of treatment with norepinephrine.	Mean duration time of norepinephrine administration calculated in hours	Day 28

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The total dose of norepinephrine infused during the study period		Day 28
ICU duration of stay in day		Day 28
Total urine output in ml during the study period		Day 28
Total of crystalloid an colloid infused during the study period (ml)		Day 28
the rate of arterial lactate at the end of norepinephrine administration		Day 28
Incidence of postoperative atrial arrhythmias (Ac/Fa, Ventricular tachycardia, Ventricular flutter, Ventricular fibrillation) during the study period		Day 28
SOFA score	SOFA score measured at the end of norepinephrine administration	Day 28

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire, Amiens
• Investigators: Principal Investigator: Pierre-Grégoire Guinot, Doctor, CHU Amiens-Picardie

Publications and helpful links

General Publications

• Guinot PG, Bernard E, Levrard M, Dupont H, Lorne E. Dynamic arterial elastance predicts mean arterial pressure decrease associated with decreasing norepinephrine dosage in septic shock. Crit Care. 2015 Jan 19;19(1):14. doi: 10.1186/s13054-014-0732-5.
• Guinot PG, Abou-Arab O, Guilbart M, Bar S, Zogheib E, Daher M, Besserve P, Nader J, Caus T, Kamel S, Dupont H, Lorne E. Monitoring dynamic arterial elastance as a means of decreasing the duration of norepinephrine treatment in vasoplegic syndrome following cardiac surgery: a prospective, randomized trial. Intensive Care Med. 2017 May;43(5):643-651. doi: 10.1007/s00134-016-4666-z. Epub 2017 Jan 24.

Study record dates

Study Major Dates

• Study Start: October 1, 2014
• Primary Completion (Actual): June 1, 2016
• Study Completion (Actual): June 1, 2016

Study Registration Dates

• First Submitted: March 18, 2015
• First Submitted That Met QC Criteria: June 23, 2015
• First Posted (Estimated): June 24, 2015

Study Record Updates

• Last Update Posted (Estimated): September 22, 2025
• Last Update Submitted That Met QC Criteria: September 17, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Vasoplegia; Organic Chemicals; Hydrocarbons; Hydrocarbons, Cyclic; Hydrocarbons, Aromatic; Amines; Catechols; Phenols; Benzene Derivatives; Alcohols; Amino Alcohols; Ethanolamines; Biogenic Monoamines; Biogenic Amines; Catecholamines; Norepinephrine
• Other Study ID Numbers: PI2014_843_0014; 2014-002707-22 (EudraCT Number)