Effect of Normal Saline Versus Balance Salt Solution Resuscitation on Kidney Function; A Randomized Open Label Controlled Study
试验速览
- 阶段
- 不适用
- 入组人数
- 107
- 试验地点
- 1
- 主要终点
- acute kidney injury
研究概览
简要总结
The purpose of this study is to determine Acute kidney injury incidence between sterofundin and normal saline ; Resuscitation shock patients
详细描述
Sample size:Compare proportion for independent two groups formula. n=sample size α risk of 0.05, Statistical power of 80% P1 =incidence of acute kidney injury (AKI) in control (0.6)* P2 =incidence of acute kidney injury (AKI) in balanced salt solution (0.4)** from Ratanarat R,Hantaweepant C,Tangkawattanakul N,et al.The clinical outcome of acute kidney injury in critically ill Thai patients stratified with RIFLE classification.J Med Assoc Thai 2009 Mar;92 Suppl 2:61-7.
α risk of 0.05, Statistical power of 80%
Sample size for interim analysis 1.11 x 97 = 107.67 total 108 (at least 50 cases each arm)
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Shock patients (hypotension with signs of poor tissue perfusion)
排除标准
- •Age < 18 yr
- •Cardiogenic shock patients (History of ST elevation and Left ventricular ejection fraction (LVEF) < 35%),
- •Prolong shock >24 hrs,
- •Received chloride rich crystalloid (0.9% saline) or chloride rich colloid > 1000 ml within 72 hrs before recruitment
- •Do-not-resuscitation patients,
- •Contraindication for IV fluid administration such as pulmonary edema.,
- •Stage V chronic kidney disease (CKD),
- •chronic Hemodialysis or Peritonealdialyse
研究组 & 干预措施
normal saline
normal saline for fluid resuscitation and maintenance for 72 hours
干预措施: normal saline (Drug)
sterofundin
sterofundin for fluid resuscitation and maintenance for 72 hours
干预措施: sterofundin (Drug)
结局指标
主要结局
acute kidney injury
时间窗: 7 day
Number of Participants with acute kidney injury divided by KIDNEY DISEASE \| IMPROVING GLOBAL OUTCOMES (KDIGO) Staging
次要结局
- sodium level(day 1-3)
- Requirement of Renal replacement therapy (RRT)(up to 7 day)
- potassium level(day 1-3)
- chloride level(day 1-3)
- bicarbonate level(day 1-3)
- 28-day mortality(28 days after admission)
- ICU mortality(ICU admission up to 28 day)
- hospital stay(during hospital admission up to 28 day)
- ICU hospital stay(during admission up to 28 day)
- mean arterial pressure(day1-3)
- dose of norepinephrine(day1-3)
- dose of adrenaline(day1-3)