A Phase , Prospective, Randomized, Open-label Study to Compare the Efficacy and Safety of Hypertonic Sodium Lactate Solution Compared With 6% HES Solution in CABG (Coronary Artery Bypass Grafting) Patients
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Efficacy
研究概览
简要总结
The choice of fluid therapy is controversial in cardiac surgery. Numerous studies have shown that colloid is better as compared to crystalloids. Several previous studies have demonstrated that Hypertonic Sodium Lactate (HSL) administration during cardiac surgery shows a promising effect. This study aims to compare hemodynamic effects and fluid balance of HSL with 6% Hydroxy Ethyl Starch (HES).
详细描述
The primary objectives of this prospective, randomized and open-label study are as follows:
- To evaluate the clinical efficacy of Hypertonic Sodium Lactate (HSL) in comparison with 6% HES to maintain hemodynamic stability in intra CABG patients related to hemodynamic status and Body fluid balance.
- To assess the safety of HSL in intra CABG patients related to defined laboratory parameters clinical adverse events which occur during the trial.
Subjects meeting enrolment criteria will be randomly assigned to HSL or 6%HES treatment groups.
Assessment of comparability will be done by unpaired student t-test or Chi-Square test or by a two-way ANOVA for repeated measures followed by post-hoc analysis when significant difference is found within the two groups.
The hypothesis tested is that HSL is effective in intra CABG surgery patients, requiring less volume with better cardiac index, as compared to 6% HES.
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, aged 45-80 years.
- •CABG patients with on or off pump procedure.
- •Ejection fraction <50%
- •Patients who have given their written informed consent.
排除标准
- •Combined operations(surgeries)
- •Patients with severe arrhythmia (VT, AF rapid response, heart block) and severe hemodynamic imbalance.
- •Severe bleeding and/or re-operation.
- •Hypernatremia> 155 mmol/L
- •Severe liver failure: SGOT and SGPT more than twice normal.
- •Severe renal failure: creatinine more than 2 mg%.
- •Patients with major diseases such as cancer, etc.
研究组 & 干预措施
HSL(Totilac)
Hypertonic Sodium Lactate
干预措施: Hypertonic sodium lactate (Drug)
6% HES (Voluven)
6% Hydroxyethyl Starch
干预措施: 6% Hydroxy Ethyl Starch (Drug)
结局指标
主要结局
Efficacy
时间窗: Assessed from baseline till upto end of surgery(mean duration of surgery was 372.47 ± 122.82 min in HSLgroup vs 380.61 ± 82.08 min in HES group
• Evaluation of efficacy of Hypertonic Sodium Lactate against 6% HES to maintain hemodynamic stability in intra CABG patients: 1. Hemodynamic status (CI, MAP, PVR/PVRI, SVR/SVRI, CVP, PAM, PAW, HR). 2. Body fluid balance (urinary output; total fluid loss including urine and hemorrhage; total fluid infusion including HSL and 6% HES, blood product and other fluids).
Safety
时间窗: Assessed from baseline till upto end of surgery(mean duration of surgery was 372.47 ± 122.82 min in HSLgroup vs 380.61 ± 82.08 min in HES group
Assess safety of HSL in intra CABG patients: 1. Lab parameters: Hb, HCT, Na,K, Cl, Mg, lactate, glucose, and arterial blood gas. 2. Adverse events
次要结局
未报告次要终点