Terlipressin in Septic Shock in Cirrhosis
Effects on Survival of Terlipressin Administration in Cirrhotic Patients With Severe Sepsis or Septic Shock. A Randomized, Open Labelled Controlled Trial
Septic shock is a frequent and severe complication in cirrhosis. Current mortality rate ranges between 50 and 80% of cases. Refractory shock, hepatorenal failure and variceal bleeding are the main causes of death of these patients. Terlipressin administration could prevent these complications and improve survival in this setting.
Aim: To evaluate the effects of terlipressin administration on hospital survival in cirrhotic patients with severe sepsis or septic shock.
Methods: Prospective, open labelled, controlled trial evaluating 72 cirrhotic patients with severe sepsis or septic shock who will be randomized to receive terlipressin plus alpha-adrenergic drugs or only alpha-adrenergic drugs at shock diagnosis. Patients will be submitted to continuous systemic hemodynamic monitoring (S. Ganz catheter or Vigileo). Changes in vasoactive systems and cytokines levels will be also evaluated.
研究概览
详细说明
研究类型
注册 (实际的)
阶段
- 阶段2
- 第三阶段
联系人和位置
学习地点
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Catalonia
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Barcelona、Catalonia、西班牙、08036
- Hospital Clinic Barcelona
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Age between 18 and 80 years;
- Diagnosis of cirrhosis based on histology or on clinical, laboratory and ultrasonographical data;
- Diagnosis of septic shock based on the presence of data compatible with systemic inflammatory response syndrome, a mean arterial pressure below 60 mmHg during more than 1 hour despite adequate fluid resuscitation, and need for circulatory support with vasopressor drugs.
Exclusion Criteria:
- More than 24 hours of evolution of the shock;
- Cardiac index < 2,5 l/min;
- History of HIV infection or clinically relevant pulmonary, renal or cardiac disease except for atrial fibrillation;
- Pregnancy;
- Advanced hepatocellular carcinoma (Milan criteria);
- Previous history of transplantation;
- Uncontrolled gastrointestinal bleeding.
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Terlipressin group
Terlipressin in continuous infusion plus alpha adrenergic drugs (noradrenaline and/or dopamine in continuous infusion)
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Terlipressin 2-12 mg/24h intravenously in continuous infusion.
Duration: until 24h after shock resolution.
其他名称：
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有源比较器：Control group
Alpha adrenergic drugs (noradrenaline and/or dopamine in continuous infusion)
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Dopamine (1-20 µg/Kg/min) and/or norepinephrine (0.05-4 µg/Kg/min) until shock resolution
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
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Hospital survival
大体时间：Hospitalization
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Hospitalization
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次要结果测量
结果测量 |
大体时间 |
|---|---|
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Refractory shock
大体时间：ICU admission
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ICU admission
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Variceal bleeding
大体时间：ICU admission
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ICU admission
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Hepatorenal syndrome
大体时间：Hospitalization
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Hospitalization
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合作者和调查者
调查人员
- 首席研究员：Javier Fernandez, MD、Hospital Clinic of Barcelona
- 研究主任：Vicente Arroyo, MD、Hospital Clinic of Barcelona
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- 05-SS-JFDEZ-1
- EUDRACAT-2005-000439-56
- 2005-000439-56 (EudraCT编号)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
IPD 计划说明
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