Effects of Terlipressin Added to Usual Care vs. Usual Care Alone on Renal Perfusion in Patients With Septic Shock
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Peak intensity
研究概览
简要总结
This open-label, randomized controlled trial aimed to investigate the effect of a fixed dose of terlipressin added to usual care vs. usual care alone on renal perfusion in patients with septic shock.
详细描述
Terlipressin is a synthetic vasopressin analog with great affinity to the V1 receptor (vasoconstrictive effect), and could selectively contract efferent arterioles, increase glomerular filtration pressure and renal perfusion. The investigators conducted this open-label, randomized controlled trial to observe the effects of a fixed dose of terlipressin added to usual care vs. usual care alone on renal perfusion in patients with septic shock. Renal perfusion was monitored by renal contrast-enhanced ultrasound. The primary outcome was peak intensity (renal perfusion parameter) at 24 hours after enrollment.
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
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult septic shock patients (age≥18 years old)
- •Norepinephrine dose was more than or equal to 15μg/min
排除标准
- •Age older than 85 years
- •Serum creatinine more than 177 μmol/L
- •Acute myocardial ischemia
- •Acute mesenteric artery ischemia
- •Expected death within 24 hours.
研究组 & 干预措施
The usual care group
Patients in the usual care group were treated with standard care.
干预措施: Usual care (Drug)
The terlipressin group
Patients in the terlipressin group received a fixed dose of terlipressin added to usual care. Terlipressin was intravenously pumped at a fixed dose of 1.3μg/kg/hour for 24 hours.
干预措施: Terlipressin treatment (Drug)
结局指标
主要结局
Peak intensity
时间窗: 24 hours after enrollment
Peak intensity is the peak concentration of contrast agent, a kind of renal perfusion parameter monitored by renal contrast-enhanced ultrasound.
次要结局
- The incidence of acute kidney injury(Within 28 days)
- urine output, mL(24 hours after enrollment)
研究者
Jingyuan,Xu
Clinical Professor
Southeast University, China