Terlipressin for refractory septic shock: a study protocol of a single center, placebo-controlled double-blind phase III RCT (The TERESEP study).
Keywords:Terlipressin, Septic shock, Catecholamine, Randomized controlled clinical trial
Introduction: In septic shock, vasopressin is a standard treatment that increases blood pressure by vasopressin receptor activation. Vasopressin can reduce catecholamine dose requirement and reduce cardiac arrhythmia in septic shock. Terlipressin is specific vasopressin 1 receptor that may replace vasopressin for septic shock treatment.The TERESEP trial evaluates the benefit of terlipressin add-on catecholamine versus catecholamine only treatment for septic shock.
Methods and analysis: This single-center randomized controlled clinical trial is enrolling hospitalized intensive care patients with septic shock with norepinephrine doses of more than 0.2 microgram/kilogram/min or norepinephrine combine with epinephrine. Patient randomized for terlipressin combined with catecholamine or placebo combined with catecholamine. The primary endpoint is successful of shock treatment within 6 hours define as the rate of mean arterial blood pressure more than 65 mmHg achievement with catecholamine requirement dose less than 0.2 mcg/kg/min. The secondary outcomes include mean blood pressure, 28 days mortality, hospital mortality, intensive care unit range of stay, rate of urine output achievement, lactate clearance, accumulative catecholamine dose, cardiac arrhythmia, 28 days alive without any organ support. The main analysis will use intension to treat approach.
Ethic and dissemination: The Ethics Committee has approved this study of Siriraj hospital, Mahidol University (COA No. SI 049/2020). The trial result will be disseminated through the presentation at medical publication. Authorship will consider and grant using the policy of Mahidol University.
Trial registrations: ClinicalTrials.govNCT04339868. Registered on April 9,2020.
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