A Multicenter,Prospective,Randomized,Controlled,Double Blind Study in China to Evaluate the Effect of Terlipressin in Patients With Septic Shock
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- 28-day Mortality
研究概览
简要总结
The purpose of this study is to evaluate the efficacy of terlipressin for treating septic shock.
详细描述
Septic shock is the most common cause of death in intensive care units and has a mortality rate of 40 to 60%.Vasopressin is commonly used as an adjunct to catecholamines to support blood pressure in refractory septic shock.Recently small sample clinical study suggest that Terlipressin,a vasopressin analogues, was effective in reversing sepsis-induced arterial hypotension and in reducing norepinephrine requirements.But its effect on mortality is unknown.Invesgators hypothesized that Terlipressin as compared with norepinephrine would decrease mortality among patients with septic shock.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Septic shock was defined by the presence of two or more diagnostic criteria for the systemic inflammatory responsesyndrome, proven or suspected infection, and hypotension (exclusion of hypertention other than sepsis)
排除标准
- •organ transplantation;
- •pregancy or breast-feeding;
- •malignancy or other irreversible disease or condition for which has a poor prognosis;
- •acute coronary syndrome;
- •chronic heart failure(NYHA III or IV)/cardiogenic shock;
- •acute mesenteric ischemia;
- •greater than 48 hours had elapsed since the patient met entry criteria;
- •estimation of incomplite treament due to financial problem;
- •use of terlipressin for blood pressure support before entry;
- •Raynaud's phenomenon, systemic sclerosis or vasospastic diathesis;
- •registration of other clinical trial which will affect the outcome of the current study
研究组 & 干预措施
terlipressin
干预措施: Terlipressin (Drug)
norepinephrine
干预措施: Norepinephrine (Drug)
结局指标
主要结局
28-day Mortality
时间窗: 28-days
The prospectively defined primary end point was death from any cause and was assessed 28 days after the start of the infusion
次要结局
- days alive and free of vasopressor(during the first 28 days after the start of the infusion)
- SOFA score(7 days)
- 90-day mortality(90 days after the start of the infusion)
研究者
Guan XiangDong
director of surgical intensive care unit
First Affiliated Hospital, Sun Yat-Sen University