Effect of low-dose Terlipressin with Albumin on Major Adverse Kidney Events in patients with Septic Shock: A Randomised Controlled Trial
试验速览
- 阶段
- Phase 3 4
- 状态
- 招募中
- 发起方
- 入组人数
- 116
- 试验地点
- 1
- 主要终点
- Incidence of MAKE30 (Major adverse kidney events within 30 days) – defined as a composite outcome of KIDIGO stage 3, or death, or both, within 30 days
研究概览
简要总结
Low dose terlipressin infusion at one micrograms per kg per hour along with albumin infusion at twenty grams in twenty four hours for first forty eight hours are expected to decrease the incidence of major adverse kidney events in thirty days in septic shock patients including decreased mortality decreased incidence of persistent renal dysfunction and decreased need of renal replacement therapy after thirty days of onset of septic shock
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •Adult patients with septic shock.
排除标准
- •LATE STAGES OF SHOCK PREGNANCY LACTATION ADVANCED CARDIAC DISEASE ADVANCED KIDNEY DISEASE ADVANCED LIVER DISEASE PERIPHERAL VASCULAR DISEASE SOLID ORGAN TRANSPLANT PATIENTS SEVERE HYPOXEMIA HIGH DOSE VASOPRESSORS ACUTE KIDNEY INJURY STAGE THREE OR MORE.
结局指标
主要结局
Incidence of MAKE30 (Major adverse kidney events within 30 days) – defined as a composite outcome of KIDIGO stage 3, or death, or both, within 30 days
时间窗: Incidence of MAKE30 (Major adverse kidney events within 30 days) – defined as a composite outcome of KIDIGO stage 3, or death, or both, within 30 days
次要结局
- Difference in NGAL level Incidence of SA-AKI(Mean SOFA Mean renal SOFA score)
研究者
ANKIT GOYAL
ALL INDIA INSTITUTE OF MEDICAL SCIENCES, NEW DELHI