2024-514149-12-00招募中3 期
Double blind randomized clinical trial comparing noradrenaline plus placebo versus noradrenaline plus terlipressin in septic shock.
Fundacion Publica Andaluza Para La Gestion De La Investigacion En Salud De Sevilla10 个研究点 分布在 1 个国家目标入组 152 人开始时间: 2024年6月4日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 152
- 试验地点
- 10
- 主要终点
- Increase in ICU-free days of life
研究概览
简要总结
Main objective is composed by: -Reduction of organ failure evaluated by Sepsis realted Organ failure Assessment score (SOFA scale) 72 h after administration of terlipressin / placebo. -Increase in ICU-free days of life measured 28 days after administration of terlipressin / placebo
研究设计
- 分配方式
- Randomized
- 主要目的
- Noradrenaline plus placebo vs noradrenaline plus terlipressin for the treatment of septic shock
- 盲法
- Double (Subject, Monitor, Investigator)
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Adult patients (18 years or older).
- •Patients with septic shock.
- •Patients with a SOFA index> 4 points. (If the patient is going to be intubated at the time of randomization, take the neurological SOFA score from the medical record)
- •Signature of the informed consent by the patient or his or her legal representative. (Informed consent may be granted by phone if the legal representative is not present at the center at the time of signing, with written re-consent required as soon as possible)
排除标准
- •Pregnant or lactating patients
- •Previous use of terlipressin during your stay in the ICU
- •Previous use of vasopressin.
- •Known allergy to terlipressin
- •Pathologies on which terlipressin is clinically indicated: gastrointestinal bleeding due to esophageal-gastric varices, hepatorenal syndrome.
- •Patients diagnosed with unstable acute coronary syndrome.
- •Patients with acute or chronic mesenteric ischemia
- •Patients with Raynaud's Phenomenon, or vasospastic disease.
- •Patients participating in another intervention clinical trial.
- •Patients with active bleeding.
- •Patients with renal replacement technique at the time of randomization.
- •Patients with some limitation of life support treatment (LLST).
结局指标
主要结局
Increase in ICU-free days of life
Increase in ICU-free days of life
Reduction of organ failure evaluated by SOFA scale
Reduction of organ failure evaluated by SOFA scale
次要结局
- Association between the achievement of the combined primary endpoint and the genetic variants of the vasopressin receptor 1a and the LNPEP gene.
- Association between the appearance of adverse effects due to the use of terlipressin, and the genetic variants of the Vasopressin 1a receptor and LNPEP gene.
- Increase in lactate clearance.
- Increase of the days with life free of mechanical ventilation.
- Increase in vasopressor-free days of life
- Mortality
- Reduction of the need for continuous renal replacement therapy (CRRT).
- Reduction of the total equivalent dose of vasopressors
- No increase in adverse effects related to the administration of vasopressors
- Association of mortality with genetic variants of the vasopressin 1a receptor and the LNPEP gene.
研究者
UICEC HUVR-HUVM
Scientific
Fundacion Publica Andaluza Para La Gestion De La Investigacion En Salud De Sevilla
研究点 (10)
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