Status:

UNKNOWN

Evaluation of Early Association of Terlipressin and Norepinephrine During Septic Shock; the TerliNor Study

Lead Sponsor:

Assistance Publique Hopitaux De Marseille

Conditions:

Septic Shock

Eligibility:

All Genders

18+ years

Phase:

PHASE4

Brief Summary

In guidelines norepinephrine is the first line vasopressor recommended in case of septic shock. Use of vasopressin is recommended when norepinephrine fails to maintain a mean arterial pressure above 6...

Eligibility Criteria

Inclusion

  • Older than 18 years
  • Dose of norepinephrine greater than 0.3 μg / kg / min
  • Lactate greater than 2.0 mmol / l

Exclusion

  • A left heart failure objectified in ultrasound transthoracique by a fraction of left(awkward) ejection of the ventricle lower than 30 % either by thermodilution transpulmonaire with a cardiac index lower than 2,5 l / min / m2 after optimization of the volémie or a central venous saturation in oxygen ( SVcO2) lower than 60 % after optimization of the blood volume.
  • Minors
  • Pregnant
  • Not having terlipressin allergy
  • Not having excipient allergy
  • A history known for recent acute coronary syndrome (\< 3mois)
  • An acute coronary syndrome defined by an increase of the troponine and a rise of the segment ST in the electrocardiogram

Key Trial Info

Start Date :

July 27 2018

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

June 1 2019

Estimated Enrollment :

40 Patients enrolled

Trial Details

Trial ID

NCT03336814

Start Date

July 27 2018

End Date

June 1 2019

Last Update

November 29 2018

Active Locations (1)

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Assistance Publique - Hôpitaux de Marseille

Marseille, France, 13354