NCT02479529

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
130

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Oct 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2014

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

March 18, 2015

Completed
3 months until next milestone

First Posted

Study publicly available on registry

June 24, 2015

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

September 22, 2025

Status Verified

September 1, 2025

Enrollment Period

1.7 years

First QC Date

March 18, 2015

Last Update Submit

September 17, 2025

Conditions

Vasoplegic Syndrome

Outcome Measures

Primary Outcomes (1)

  • The duration of treatment with norepinephrine.

    Mean duration time of norepinephrine administration calculated in hours

    Day 28

Secondary Outcomes (7)

  • 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

  • +2 more secondary outcomes

Study Arms (2)

administration of norepinephrine by dynamic elastance

EXPERIMENTAL

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

Drug: Norepinephrine

control administration of norepinephrine

OTHER

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

Interventions

NorepinephrineDRUG

Administration and weaning of norepinephrine is based on dynamic arterial elastance

Also known as: Dynamic arterial elastance
administration of norepinephrine by dynamic elastance

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Permanent atrial fibrillation
  • Treatment with dobutamine and/or epinephrine
  • Pregnant woman
  • Patient under guardianship or private public law
  • Internal pacemaker
  • Hypothermia
  • Patient refusal

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Amiens-Picardie

Amiens, Picardie, 80054, France

Location

Related Publications (2)

  • 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.

    PMID: 25598221BACKGROUND

  • 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.

    PMID: 28120005RESULT

MeSH Terms

Conditions

Vasoplegia

Interventions

Norepinephrine

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

EthanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsAminesBiogenic MonoaminesBiogenic AminesCatecholaminesCatecholsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbons

Study Officials

  • Pierre-Grégoire Guinot, Doctor

    CHU Amiens-Picardie

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 18, 2015

First Posted

June 24, 2015

Study Start

October 1, 2014

Primary Completion

June 1, 2016

Study Completion

June 1, 2016

Last Updated

September 22, 2025

Record last verified: 2025-09

Locations

FR(1)