COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03336814
Recruitment Status : Unknown
Verified November 2017 by Assistance Publique Hopitaux De Marseille.
Recruitment status was:  Recruiting
First Posted : November 8, 2017
Last Update Posted : November 29, 2018
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

Layout table for study information
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 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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

Inclusion Criteria:

  • Older than 18 years
  • Dose of norepinephrine greater than 0.3 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 identifier (NCT number): NCT03336814

Layout table for location contacts
Contact: Gary Duclos
Contact: Camille Delannoy 0491382747 ext +33

Layout table for location information
Assistance Publique - Hôpitaux de Marseille Recruiting
Marseille Cedex 05, France, 13354
Contact: Duclos Gary   
Sponsors and Collaborators
Assistance Publique Hopitaux De Marseille
Layout table for investigator information
Study Director: Jean-Olivier ARNAUD Assistance Publique Hôpitaux de Marseille
Layout table for additonal information
Responsible Party: Assistance Publique Hopitaux De Marseille Identifier: NCT03336814    
Other Study ID Numbers: 2017-07
2017-000441-43 ( EudraCT Number )
First Posted: November 8, 2017    Key Record Dates
Last Update Posted: November 29, 2018
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
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:
Additional relevant MeSH terms:
Layout table for MeSH terms
Shock, Septic
Pathologic Processes
Systemic Inflammatory Response Syndrome
Antihypertensive Agents
Vasoconstrictor Agents