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

Sponsor

Centre Hospitalier Universitaire, Amiens (Other)

Overall Status

Completed

CT.gov ID

NCT02479529

Collaborator

(none)

130

Enrollment

Location

Arms

Duration (Months)

6.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Vasoplegic Syndrome	Drug: Norepinephrine Drug: Norepinephrine	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

130 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Oct 1, 2014

Actual Primary Completion Date :

Jun 1, 2016

Actual Study Completion Date :

Jun 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
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 Administration and weaning of norepinephrine is based on dynamic arterial elastance Other Names: 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).	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). Other Names: Control

Arm

Intervention/Treatment

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

Administration and weaning of norepinephrine is based on dynamic arterial elastance

Other Names:

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).

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).

Other Names:

Control

Outcome Measures

Primary Outcome Measures

The duration of treatment with norepinephrine. [Day 28]
Mean duration time of norepinephrine administration calculated in hours

Secondary Outcome Measures

The total dose of norepinephrine infused during the study period [Day 28]
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CHU Amiens-Picardie	Amiens	Picardie	France	80054

Sponsors and Collaborators

Centre Hospitalier Universitaire, Amiens

Investigators

Principal Investigator: Pierre-Grégoire Guinot, Doctor, CHU Amiens-Picardie

Study Documents (Full-Text)

None provided.

More Information

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

Responsible Party:

Centre Hospitalier Universitaire, Amiens

ClinicalTrials.gov Identifier:

NCT02479529

Other Study ID Numbers:

PI2014_843_0014
2014-002707-22

First Posted:

Jun 24, 2015

Last Update Posted:

Oct 21, 2016

Last Verified:

Oct 1, 2016

Additional relevant MeSH terms:

Vasoplegia

Norepinephrine

Study Results

No Results Posted as of Oct 21, 2016