The Efficacy of Hypertonic Lactate Solution in CABG(Coronary Artery Bypass Grafting) Patients
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Hemodynamic status
研究概览
简要总结
Previous clinical trials with 11.2% Hypertonic Ringer's Lactate in post-operative CABG subjects have shown an increase in several cardiac performance parameters, with lesser volume of resuscitation fluid required to reach circulation volume, as compared to Sodium Chloride.It also does not cause hyperchloremic acidosis, which is of value in treating shock patients.
The primary objectives of this prospective, randomized, open-label trial are to evaluate the clinical efficacy of hypertonic lactate in comparison to Ringer's lactate to maintain hemodynamic stability in intra- and post-CABG subjects in relation to hemodynamic status and body fluid balance, as well as to assess its safety in terms of lab parameters and occurrence of adverse events.The secondary objectives are to evaluate comparative clinical efficacy of the two fluids in relation to reduction in concomitant drug utilization, duration of ventilator usage, length of stay in ICU as well as total duration of hospitalization and neurocognitive status upto a period of 1 year post-CABG.
详细描述
Details provided in summary.
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
- 45 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female
- •45 to 80 years
- •CABG patients with on or off pump procedure
- •Ejection fraction < 50%
- •Given informed consent
排除标准
- •Combined operations
- •Severe arrhythmia(VT, AF rapid response, heart blocks) and severe hemodynamic imbalance
- •Severe bleeding and/or re-operation
- •Hypernatremia > 155 mMol/L
- •Severe liver failure(SGOT, SGPT 2x normal)
- •Severe renal failure(Creatinine > 2 mg. %)
- •Major diseases(eg. cancer)
研究组 & 干预措施
Group 1
Hypertonic lactate
干预措施: Hypertonic lactate (Drug)
Group 2
Ringer's lactate
干预措施: Ringer's lactate (Drug)
结局指标
主要结局
Hemodynamic status
时间窗: During and 12 hours after CABG surgery
次要结局
- Safety of hypertonic sodium lactate for maintaining hemodynamic stability(During and 12 hours after CABG surgery)