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

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ClinicalTrials.gov Identifier: NCT03336814
Recruitment Status : Recruiting
First Posted : November 8, 2017
Last Update Posted : September 10, 2018
Sponsor:
Information provided by (Responsible Party):
Assistance Publique Hopitaux De Marseille

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 65mmHg or in salvage. Several studies failed to show a superiority of vasopressin over norepinephrine but none evaluated the effect of an early association on organ failure. Terlipressin is a pro-drug of vasopressin which has the same vasoconstrictor effect. We hypothesize that the early association of terlipressin and norepinephrine during septic shock reduces organ failure.

This bi centric, double-blinded, randomised, controlled versus placebo study includes 40 patients. Randomisation will be stratified between centers (two university affiliated intensive care units of Assistance-Publique-Hôpitaux de Marseille, Marseille, France). All patients with septic shock needing more than 0,5µg/kg/min of norepinephrine to reach PAM objectives are randomised, after hemodynamic evaluation and optimisation, to receive continuous infusions of terlipressin (0,01mg/kg/min) or placebo (physiologic serum). The 2 groups receive steroid therapy (continuous intravenous hydrocortisone perfusion) at this time. Clinicians are blinded of perfusion used. Use of terlipressin remains possible in salvage when patients need more of 1µg/kg/min of norepinephrine on physician's decision. Patients with acute ischemic or septic heart failure are excluded of the study.

Primary objective is sepsis related Sequential Organ Failure Assessment (SOFA) score difference between the groups at day 3. Secondary objectives are mortality at day 28, lactates clearance in the first 48hours, renal function (evaluates with AKIN criteria) and use of renal replacement therapy.


Condition or disease Intervention/treatment Phase
Septic Shock Drug: Terlipressin Other: Placebo Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Evaluation of Early Association of Terlipressin and Norepinephrine During Septic Shock; the TerliNor Study
Actual Study Start Date : July 27, 2018
Estimated Primary Completion Date : December 1, 2018
Estimated Study Completion Date : June 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Shock

Arm Intervention/treatment
Experimental: terlipressin associated with norepinephrine Drug: Terlipressin
Administration of terlipressine

Placebo Comparator: placebo (physiologic serum) associated with norepinephrine Other: Placebo
Administration of placebo




Primary Outcome Measures :
  1. Sequential Organ Failure Assessment (SOFA) score difference between the groups [ Time Frame: Day 3 ]

Secondary Outcome Measures :
  1. Mortality rate [ Time Frame: Day 28 ]
  2. Lactates clearance [ Time Frame: 48 hours ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Older than 18 years
  • Dose of norepinephrine greater than 0.5 μg / kg / min
  • Lactate greater than 2.0 mmol / l

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03336814


Contacts
Contact: Gary Duclos gary.duclos@ap-hm.fr
Contact: Camille Delannoy 0491382747 ext +33 drci@ap-hm.fr

Locations
France
Assistance Publique - Hôpitaux de Marseille Recruiting
Marseille Cedex 05, France, 13354
Contact: Duclos Gary       gary.duclos@ap-hm.fr   
Sponsors and Collaborators
Assistance Publique Hopitaux De Marseille
Investigators
Study Director: Jean-Olivier ARNAUD Assistance Publique Hôpitaux de Marseille

Responsible Party: Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier: NCT03336814     History of Changes
Other Study ID Numbers: 2017-07
2017-000441-43 ( EudraCT Number )
First Posted: November 8, 2017    Key Record Dates
Last Update Posted: September 10, 2018
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Assistance Publique Hopitaux De Marseille:
Terlipressin
norepinephrine

Additional relevant MeSH terms:
Shock
Shock, Septic
Pathologic Processes
Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Norepinephrine
Terlipressin
Lypressin
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Vasoconstrictor Agents
Antihypertensive Agents
Hemostatics
Coagulants
Antidiuretic Agents
Natriuretic Agents