CompletedNCT02479529SNEADUpdated Sep 22, 2025

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

A Phase 3 interventional study of Norepinephrine and Norepinephrine in Vasoplegic Syndrome, sponsored by Centre Hospitalier Universitaire, Amiens. Completed at 1 site in France. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2025-09-22.

Sponsored by Centre Hospitalier Universitaire, Amiens · Phase 3, Interventional, and Treatment

Phase: Phase 3
Study type: Interventional
Enrollment: 130
Allocation: Randomized
Ages: 18 Years to 70 Years
Sex: All

Study 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.

Conditions studied

Vasoplegic Syndrome

Browse trials for

Vasoplegia 45

Who can participate

Ages eligible: 18 Years to 70 Years
Sexes eligible: All
Accepts healthy volunteers: No

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

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 design

Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 130 participants (actual)

Study arms

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
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

Interventions

DrugNorepinephrine
Administration and weaning of norepinephrine is based on dynamic arterial elastance
Also known as: Dynamic arterial elastance
DrugNorepinephrine
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).
Also known as: Control

What researchers measure

Primary outcomes

The duration of treatment with norepinephrine.
Mean duration time of norepinephrine administration calculated in hours
Time frame: Day 28

Secondary outcomes

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

Study locations

1 site

CHU Amiens-Picardie
Amiens, Picardie 80054, France

References and documents

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. PubMed 25598221 ↗
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. PubMed 28120005 ↗

Registry details

Key details

Study ID: NCT02479529
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Responsible party: Sponsor
First posted: Jun 24, 2015
Start date: Oct 2014
Primary completion: Jun 2016
Completion: Jun 2016
Last update: Sep 22, 2025

Study contacts

Pierre-Grégoire Guinot, Doctor

principal investigator · CHU Amiens-Picardie

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

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