NCT00269685已完成2 期
Comparative Prospective Study of Vasopressin and Catecholamine in Septic Shock
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 20
- 主要终点
- To compare the efficiency of vasopressine to the standard and usual treatment of septic shock on the reverse of the hemodynamic criterion of septic shock
研究概览
简要总结
The purpose of this study is to compare the classical tactics in the treatment of septic shock (dopamine, noradrenalin and dobutamine) to the use of vasopressin as first choice pressor.
Vasopressin seems to be an interesting alternative in the treatment of septic shock. To this date, available studies have showed that it could correct hyperkinetic syndrome and vasoplegia in septic shocks without noticeable side effect. It as been demonstrated that vasopressin improves renal function, as no effect on digestive organs and as no metabolic effect.
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 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Legally major patient presenting a septic shock.
- •The time window between beginning of symptoms and onset of treatment is established at 12 hours.
- •The patient must be intubated and mechanically ventilated.
- •Patient presenting a mean arterial blood pressure of less than 60 mm Hg after adequate fluid resuscitation (at least 1 L of colloid or crystalloid) and 10 ug/Kg/min of dopamine.
- •Patient presenting a cardiac index of at least 3 L/min/m2
排除标准
- •Shock other than septic
- •cardiac hypokinesia
- •a pre-existing organic renal failure that needs hemodyalisis
- •oesophagal or gastric phatology that would lead to a naso-gastric tube contraindication
结局指标
主要结局
To compare the efficiency of vasopressine to the standard and usual treatment of septic shock on the reverse of the hemodynamic criterion of septic shock
次要结局
- To compare these two categories of treatment on:
- tonometric parameters
- renal function
- in term of tolerance: metabolic effects (increase in lactate and glycaemia), cardiac effects (tachycardia being defined as a heart rate increase of 15%), increase of cardiac enzymes (troponine, CK, CK-MB), and cutanuous vasoconstriction.
研究者
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