A Double-blind, Randomised, Placebo-controlled, Phase 2b/3 Adaptive Clinical Trial Investigating the Efficacy and Safety of Selepressin as Treatment for Patients with Vasopressor-dependent Septic Shock - SEPSIS-ACT

Ferring Pharmaceuticals A/S0 个研究点目标入组 868 人开始时间: 2015年7月3日最近更新: 2022年1月4日

试验速览

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•1. 18 years of age or older.
•2. Proven or suspected infection.
•3. Septic shock defined as hypotension (systolic blood pressure less than 90 mmHg OR MAP less than 65 mmHg) requiring vasopressor treatment (i.e. any dose of norepinephrine / noradrenaline greater than 5 µg/min) despite adequate fluid resuscitation (at least one litre for hypotension).
•4. Informed consent obtained in accordance with local regulations.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 900
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 900

•1. Not possible to initiate IMP treatment within 12 hours from onset of vasopressor treatment for septic shock.
•2. Primary cause of hypotension not due to sepsis (e.g. major trauma including traumatic brain injury, haemorrhage, burns, or congestive heart failure/cardiogenic shock).
•3. Previous severe sepsis with ICU admission within this hospital stay.
•4. Known/suspected acute mesenteric ischaemia.
•5. Suspicion of concomitant acute coronary syndrome based on clinical symptoms and/or ECG during this episode of septic shock.
•6. Chronic mechanical ventilation for any reason OR severe chronic obstructive pulmonary disease (COPD) requiring either continuous daily oxygen use during the preceding 30 days or mechanical ventilation (for acute exacerbation of COPD) during the preceding 30 days.
•7. Received bone marrow transplant during the preceding 6 months or chemotherapy during the preceding 30 days for lymphoma or leukemia.
•8. Known to be pregnant.
•9. Decision to limit full care taken before obtaining informed consent.
•10. Use of vasopressin in the past 12 hours prior to start of the IMP infusion or use of terlipressin within 7 days prior to start of the IMP infusion.
•11. Prior enrolment in the trial.
•12. Prior use of an investigational medicinal product within the last month OR planned or concurrent participation in a clinical trial for any investigational drug or investigational device.

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