The Efficacy and Safety of Hypertonic Lactate Solution as Fluid Resuscitation Compared With Ringer's Lactate in Post-CABG (Coronary Artery Bypass Grafting) Patients
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 230
- 试验地点
- 1
- 主要终点
- hemodynamic stability
研究概览
简要总结
Prospective, randomized, open-label study to assess the efficacy and safety of hypertonic lactate solution, compared to Ringer's Lactate as fluid resuscitation to maintain hemodynamic stability in post-coronary artery bypass grafting(CABG) patients. Patients who were eligible received either hypertonic lactate solution or Ringer's Lactate post-CABG in the ICU when fluid resuscitation was needed.
详细描述
Prospective, randomized, open-label study to assess the efficacy and safety of hypertonic lactate solution, compared to Ringer's Lactate as fluid resuscitation to maintain hemodynamic stability in post-coronary artery bypass grafting(CABG) patients. Patients who were eligible received either hypertonic lactate solution or Ringer's Lactate post-CABG observed in the first 12 hours in the ICU when fluid resuscitation was needed.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who have given their written informed consent.
- •Male or female, aged 18-75 years.
- •Post-operative CABG on pump or off pump in ICU.
- •Patients who need fluid resuscitation.
排除标准
- •Combined operations.
- •Need for intra aortic balloon pump (IABP).
- •Patients with severe arrhythmia (VT, AF rapid response, heart block).
- •Severe hemodynamic imbalance.
- •Severe bleeding and/or re-operation.
- •Liver dysfunction(SGOT and SGPT 2x normal).
- •Renal failure (Creatinine >2 mg%).
研究组 & 干预措施
HL
Hypertonic lactate group
干预措施: Hypertonic lactate (Drug)
RL
Ringer's lactate
干预措施: Ringer's lactate (Drug)
结局指标
主要结局
hemodynamic stability
时间窗: 12 hours post-CABG surgery
次要结局
- Safety of hypertonic sodium lactate for maintaining the hemodynamic stability(12 hours post-CABG surgery)