Clinical trial NCT02479529: Weaning of Norepinephrine Guided by the Dynamic Arterial Compliance in Cardiac Surgery Post Operative.
Official title: Weaning of Norepinephrine Guided by the Dynamic Arterial Compliance in Cardiac Surgery Post Operative.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Vasoplegic Syndrome
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
First posted: 2015-06-24
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: The duration of treatment with norepinephrine.
timeFrame: Day 28
Secondary outcomes:
measure: The total dose of norepinephrine infused during the study period
timeFrame: Day 28
measure: ICU duration of stay in day
timeFrame: Day 28
measure: Total urine output in ml during the study period
timeFrame: Day 28
measure: Total of crystalloid an colloid infused during the study period (ml)
timeFrame: Day 28
measure: the rate of arterial lactate at the end of norepinephrine administration
timeFrame: Day 28
measure: Incidence of postoperative atrial arrhythmias (Ac/Fa, Ventricular tachycardia, Ventricular flutter, Ventricular fibrillation) during the study period
timeFrame: Day 28
measure: SOFA score
timeFrame: Day 28
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens-Picardie
state: Picardie
Study officials:
affiliation: CHU Amiens-Picardie
name: Pierre-Grégoire Guinot, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.