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

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Vasoplegia 48

In context

Vasoplegia

48 studies on the registry are indexed under Vasoplegia; 19 are open to participants now.

This study's enrollment of 130 is above the median of 110 across 27 interventional studies indexed under Vasoplegia.

Browse Vasoplegia studies →

Lead sponsor

Centre Hospitalier Universitaire, Amiens is the lead sponsor of 586 studies on the registry; 185 are open to participants now.

Browse Centre Hospitalier Universitaire, Amiens studies →

Counted across the registry records on this site, refreshed daily.

Who can participate

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 ↗

Timeline

Tracking since Sep 25, 2026

Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Oct 2014, a primary completion of Jun 2016 and a completion of Jun 2016. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered: Mar 18, 2015
First posted: Jun 24, 2015
Start: Oct 2014
Primary completionActual: Jun 2016
CompletionActual: Jun 2016
Last update: Sep 22, 2025

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

No changes since tracking began. The registry record was last updated on Sep 22, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

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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This study is completed, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: Norepinephrine

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