Effects on Survival of Terlipressin Administration in Cirrhotic Patients With Severe Sepsis or Septic Shock. A Randomized, Open Labelled Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Hospital survival
研究概览
简要总结
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.
详细描述
Prospective, open labelled, RCT evaluating 72 cirrhotic patients with severe sepsis or septic shock (36 per arm) who were randomized to receive terlipressin plus alpha-adrenergic drugs or alpha-adrenergic drugs in the first 24h after septic shock diagnosis. Impact of terlipressin administration on shock reversal, changes in vasoactive systems, inflammatory response, incidence of variceal bleeding and type-1 HRS and ICU and hospital mortality was investigated
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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;
- •Advanced hepatocellular carcinoma (Milan criteria);
- •Previous history of transplantation;
- •Uncontrolled gastrointestinal bleeding.
研究组 & 干预措施
Terlipressin group
Terlipressin in continuous infusion plus alpha adrenergic drugs (noradrenaline and/or dopamine in continuous infusion)
干预措施: Terlipressin (Drug)
Control group
Alpha adrenergic drugs (noradrenaline and/or dopamine in continuous infusion)
干预措施: alpha adrenergic drugs (Drug)
结局指标
主要结局
Hospital survival
时间窗: Hospitalization
次要结局
- Refractory shock(ICU admission)
- Variceal bleeding(ICU admission)
- Hepatorenal syndrome(Hospitalization)
研究者
Vicente Arroyo Perez
Senior Hepatologist Consultant
Hospital Clinic of Barcelona