跳至主要内容
临床试验/EUCTR2020-005756-37-ES
EUCTR2020-005756-37-ES进行中(未招募)1 期

Double blind randomized clinical trial comparing noradrenaline plus placebo versus noradrenaline plus terlipressin in septic shock

Fundación Pública Andaluza para la Gestión de la0 个研究点目标入组 152 人开始时间: 2021年7月27日最近更新:
相关药物

试验速览

阶段
1 期
状态
进行中(未招募)
发起方
入组人数
152

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional clinical trial of medicinal product

入排标准

性别
All

入选标准

  • 1. Adult patients (18 years or older).
  • 2. Patients with septic shock.
  • 3. Patients with a SOFA index> 4 points.
  • 4. Venous oxygen saturation (SvO2)> 70%
  • 5. Central venous pressure (CVP)> 8 mmHg.
  • 6. Signature of the informed consent by the patient or his or her legal representative.
  • 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 114
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range 38

排除标准

  • 1. Pregnant or lactating patients.
  • 2. Pathologies on which terlipressin is clinically indicated: gastrointestinal bleeding due to esophageal-gastric varices, hepatorenal syndrome.
  • 3. Patients diagnosed with unstable acute coronary syndrome.
  • 4. Patients with acute or chronic mesenteric ischemia.
  • 5. Patients with Raynaud's Phenomenon, or vasospastic disease.
  • 6. Patients participating in another intervention clinical trial.
  • 7. Patients with active bleeding.
  • 8. Patients with renal replacement technique at the time of randomization.
  • 9. Patients with some limitation of life support treatment (LLST).
  • 10. Previous use of terlipressin during your stay in the ICU.

研究者

发起方
Fundación Pública Andaluza para la Gestión de la

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