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

Primary Purpose

Vasoplegic Syndrome

Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Norepinephrine
Norepinephrine
Sponsored by
Centre Hospitalier Universitaire, Amiens
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vasoplegic Syndrome

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • CHU Amiens-Picardie

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

administration of norepinephrine by dynamic elastance

control administration of norepinephrine

Arm Description

The norepinephrine weaning strategy is based on an index that reflects the vasomotor tone: dynamic arterial elastance

The usual procedure of withdrawal norepinephrine is based on hemodynamic parameters (blood pressure), clinical (cutaneous perfusion, mottling, hourly diuresis) and biological (SVO2, arterial lactate).

Outcomes

Primary Outcome Measures

The duration of treatment with norepinephrine.
Mean duration time of norepinephrine administration calculated in hours

Secondary Outcome Measures

The total dose of norepinephrine infused during the study period
ICU duration of stay in day
Total urine output in ml during the study period
Total of crystalloid an colloid infused during the study period (ml)
the rate of arterial lactate at the end of norepinephrine administration
Incidence of postoperative atrial arrhythmias (Ac/Fa, Ventricular tachycardia, Ventricular flutter, Ventricular fibrillation) during the study period
SOFA score
SOFA score measured at the end of norepinephrine administration

Full Information

First Posted
March 18, 2015
Last Updated
October 20, 2016
Sponsor
Centre Hospitalier Universitaire, Amiens
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1. Study Identification

Unique Protocol Identification Number
NCT02479529
Brief Title
Weaning of Norepinephrine Guided by the Dynamic Arterial Compliance in Cardiac Surgery Post Operative.
Acronym
SNEAD
Official Title
Weaning of Norepinephrine Guided by the Dynamic Arterial Compliance in Cardiac Surgery Post Operative.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
October 2014 (undefined)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
June 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire, Amiens

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vasoplegic Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
130 (Actual)

8. Arms, Groups, and Interventions

Arm Title
administration of norepinephrine by dynamic elastance
Arm Type
Experimental
Arm Description
The norepinephrine weaning strategy is based on an index that reflects the vasomotor tone: dynamic arterial elastance
Arm Title
control administration of norepinephrine
Arm Type
Other
Arm Description
The usual procedure of withdrawal norepinephrine is based on hemodynamic parameters (blood pressure), clinical (cutaneous perfusion, mottling, hourly diuresis) and biological (SVO2, arterial lactate).
Intervention Type
Drug
Intervention Name(s)
Norepinephrine
Other Intervention Name(s)
Dynamic arterial elastance
Intervention Description
Administration and weaning of norepinephrine is based on dynamic arterial elastance
Intervention Type
Drug
Intervention Name(s)
Norepinephrine
Other Intervention Name(s)
Control
Intervention Description
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).
Primary Outcome Measure Information:
Title
The duration of treatment with norepinephrine.
Description
Mean duration time of norepinephrine administration calculated in hours
Time Frame
Day 28
Secondary Outcome Measure Information:
Title
The total dose of norepinephrine infused during the study period
Time Frame
Day 28
Title
ICU duration of stay in day
Time Frame
Day 28
Title
Total urine output in ml during the study period
Time Frame
Day 28
Title
Total of crystalloid an colloid infused during the study period (ml)
Time Frame
Day 28
Title
the rate of arterial lactate at the end of norepinephrine administration
Time Frame
Day 28
Title
Incidence of postoperative atrial arrhythmias (Ac/Fa, Ventricular tachycardia, Ventricular flutter, Ventricular fibrillation) during the study period
Time Frame
Day 28
Title
SOFA score
Description
SOFA score measured at the end of norepinephrine administration
Time Frame
Day 28

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pierre-Grégoire Guinot, Doctor
Organizational Affiliation
CHU Amiens-Picardie
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Amiens-Picardie
City
Amiens
State/Province
Picardie
ZIP/Postal Code
80054
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
25598221
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.
Results Reference
background
PubMed Identifier
28120005
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.
Results Reference
derived

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

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