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

Vasoplegic Syndrome Clinical Trial

— SNEAD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02479529
• Other study ID #: PI2014_843_0014
• Secondary ID: 2014-002707-22
• Status: Completed
• Phase: Phase 3
• First received: March 18, 2015
• Last updated: October 20, 2016
• Start date: October 2014
• Est. completion date: June 2016

Study information

• Verified date: October 2016
• Source: Centre Hospitalier Universitaire, Amiens
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 130
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Vasoplegia
• Vasoplegic Syndrome

Intervention

Drug:
• Norepinephrine
Administration and weaning of norepinephrine is based on dynamic arterial elastance
• 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).

Locations

Country	Name	City	State
France	CHU Amiens-Picardie	Amiens	Picardie

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire, Amiens

Country where clinical trial is conducted

France, 

References & Publications (1)

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;19:14. doi: 10.1186/s13054-014-0732-5. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The duration of treatment with norepinephrine.	Mean duration time of norepinephrine administration calculated in hours	Day 28	No
Secondary	The total dose of norepinephrine infused during the study period		Day 28	No
Secondary	ICU duration of stay in day		Day 28	No
Secondary	Total urine output in ml during the study period		Day 28	No
Secondary	Total of crystalloid an colloid infused during the study period (ml)		Day 28	No
Secondary	the rate of arterial lactate at the end of norepinephrine administration		Day 28	No
Secondary	Incidence of postoperative atrial arrhythmias (Ac/Fa, Ventricular tachycardia, Ventricular flutter, Ventricular fibrillation) during the study period		Day 28	Yes
Secondary	SOFA score	SOFA score measured at the end of norepinephrine administration	Day 28	No