NL-OMON43990
已完成
2 期
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 - Ferring 000133 SEPSIS-ACT
概览
- 阶段
- 2 期
- 干预措施
- 未指定
- 疾病 / 适应症
- shock
- 发起方
- Ferring
- 入组人数
- 225
- 状态
- 已完成
- 最后更新
- 2年前
概览
简要总结
暂无简介。
研究者
入排标准
入选标准
- •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 \*g/min)
- •despite adequate fluid resuscitation (at least one litre for hypotension).
- •4\. Informed consent obtained in accordance with local regulations.
排除标准
- •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.
结局指标
主要结局
未指定
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