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

Phase 3

Completed

• Conditions: Vasoplegic Syndrome
• Interventions: Drug: Norepinephrine

• Registration Number: NCT02479529
• Lead Sponsor: Centre Hospitalier Universitaire, Amiens

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-10
• Study First Submitted: 2015-03-18
• Study First Submitted QC: 2015-06-23
• Study First Posted: 2015-06-24
• Primary Completion: 2016-06
• Study Completion: 2016-06
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-20
• Last Update Posted: 2016-10-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 130

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
control administration of norepinephrine	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).
administration of norepinephrine by dynamic elastance	Norepinephrine	The norepinephrine weaning strategy is based on an index that reflects the vasomotor tone: dynamic arterial elastance

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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	Day 28	SOFA score measured at the end of norepinephrine administration
The total dose of norepinephrine infused during the study period	Day 28

Trial Locations

Locations (1)

CHU Amiens-Picardie; 🇫🇷 Amiens, Picardie, France