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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03336814|
Recruitment Status : Not yet recruiting
First Posted : November 8, 2017
Last Update Posted : November 8, 2017
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|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Evaluation of Early Association of Terlipressin and Norepinephrine During Septic Shock; the|
|Estimated Study Start Date :||January 1, 2018|
|Estimated Primary Completion Date :||December 1, 2018|
|Estimated Study Completion Date :||June 1, 2019|
|Experimental: terlipressin associated with norepinephrine||
Administration of terlipressine
|Placebo Comparator: placebo (physiologic serum) associated with norepinephrine||
Administration of placebo
- Sequential Organ Failure Assessment (SOFA) score difference between the groups [ Time Frame: Day 3 ]
- Mortality rate [ Time Frame: Day 28 ]
- Lactates clearance [ Time Frame: 48 hours ]
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
|Contact: Gary Duclosfirstname.lastname@example.org|
|Contact: Camille Delannoy||0491382747 ext +email@example.com|
|Assistance Publique - Hôpitaux de Marseille|
|Marseille Cedex 05, France, 13354|
|Study Director:||Jean-Olivier ARNAUD||Assistance Publique Hôpitaux de Marseille|