Fluid Resuscitation Management for Patients With Septic Shock: the Efficacy and Safety Comparison Between Bicarbonated Ringer's Solution and Lactated Ringer's Solution
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 260
- 试验地点
- 1
- 主要终点
- the average doses of vasopressors
研究概览
简要总结
In this prospective randomized controlled trial, investigators aim to study the effects and safety of bicarbonated Ringer's solution in patients with septic shock compared with lactated ringer's solution, and provide evidence for current fluid resuscitation strategies for septic shock.
详细描述
Although the latest guidelines recommend crystalloids as the first choice for the patients' fluid resuscitation, it still remains controversial that which crystalloid solution is the best choice. It is reported that balanced crystalloid can result in better outcomes than saline for critically ill patients. However, there are few studies conducted between different crystalloid solutions.
Lactated ringer's solution is the longest-used crystalloid solution. Compared with lactated ringer's solution whose anion is lactate, the anion of bicarbonate ringer's solution is bicarbonate. And lactate needs to be metabolized into bicarbonate through the mitochondria of the liver before it can play an alkalization role. Therefore, in theory, bicarbonate ringer's solution does not need to rely on liver metabolism, the onset time to maintain acid-base balance is shorter, and it may be more suitable for patients with severe acidosis. In patients with septic shock, the incidence of moderate to severe metabolic is increased. Bicarbonate ringer's solution can directly supplement the concentration of bicarbonate, while lactated ringer's solution needs to take time and be metabolized in the liver. Thus, we hypothesize that bicarbonate ringer's solution is more effective for patients with shock and metabolic acidosis than lactated ringer's solution.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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
- •At the age of 18 to 75;
- •Being treated in the ICU;
- •Diagnosed as septic shock according tho the definition of Sepsis 3.0 with fluid resuscitation requirement.
排除标准
- •Severe hepatic failure;
- •Possible brain injury;
- •With absolute contraindications for central vena catheterization;
- •Ever participated in another clinical trial within 30 days prior enrollment;
- •Have corrected metabolic acidosis through alkaline drug application within 24 hours prior to enrollment;
- •Hypermagnesemia or hypothyroidism;
- •Pregnant of breast-feeding women;
- •Considered inevitable death;
- •Other situations where investigators think enrollment is not appropriate.
研究组 & 干预措施
lactated ringer's solution
We apply lactated ringer's solution as resuscitation fluid to patients with septic shock.
干预措施: Lactated Ringer's solution (Drug)
bicarbonated ringer's solution
We apply bicarbonated ringer's solution as resuscitation fluid to patients with septic shock.
干预措施: Bicarbonated Ringer's solution (Drug)
结局指标
主要结局
the average doses of vasopressors
时间窗: From the onset of shock to the first blood pressure stabilization (MAP≥65mmHg), or serum lactate <2.2mmol/l, or discontinuation of vasoactive drugs. About 24 hours.
total doses of norepinephrine÷weight÷duration of usage
次要结局
- the PH value(0, 3 hours, 6 hours, 12 hours, 24 hours)
- mortality from any cause(on the day28 after enrollment)
- the rate of metabolic alkalosis(From the onset of shock to the first blood pressure stabilization (MAP≥65mmHg), or serum lactate <2.2mmol/l, or discontinuation of vasoactive drugs. About 24 hours.)
- total volume of fluids before hemodynamic stabilization(From the onset of shock to the first blood pressure stabilization (MAP≥65mmHg), or serum lactate <2.2mmol/l, or discontinuation of vasoactive drugs. About 24 hours.)
- the change of serum lactate value at the 6th hour(6 hours)
- the BE value(0, 3 hours, 6 hours, 12 hours, 24 hours)
- shock reversal time(From the onset of shock to the first blood pressure stabilization (MAP≥65mmHg), or serum lactate <2.2mmol/l, or discontinuation of vasoactive drugs. About 24 hours.)
- the proportion of patients whose serum lactate decreases 30%(From the onset of shock to the first blood pressure stabilization (MAP≥65mmHg), or serum lactate <2.2mmol/l, or discontinuation of vasoactive drugs. About 24 hours.)
研究者
ZhiYong Peng
Professor; Chief physician
Zhongnan Hospital