Septic Shock Clinical Trial
Official title:
Evaluation of Early Association of Terlipressin and Norepinephrine During Septic Shock; the TerliNor Study
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.
n/a
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