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

Overview

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.

Study Type

• Study Type: Interventional
• Study Design
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Primary Purpose: Treatment
  • Masking: None (Open Label)
• Study Primary Completion Date: June 2016

Interventions

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

Arms, Groups and Cohorts

• Experimental: administration of norepinephrine by dynamic elastance
  • The norepinephrine weaning strategy is based on an index that reflects the vasomotor tone: dynamic arterial elastance
• 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).

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

• 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
  • Time Frame: Day 28
  • SOFA score measured at the end of norepinephrine administration

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 70 Years

Are Healthy Volunteers Accepted: No

Investigator Details

• Lead Sponsor
  • Centre Hospitalier Universitaire, Amiens
• Provider of Information About this Clinical Study
  • Sponsor
• Overall Official(s)
  • Pierre-Grégoire Guinot, Doctor, Principal Investigator, CHU Amiens-Picardie

References

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.