Sodium Bicarbonate Ringer's Solution Versus Normal Saline for Early Fluid Resuscitation in Patients With Sepsis
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 450
- 试验地点
- 1
- 主要终点
- Change in Sequential Organ Failure Assessment(SOFA) value at 24h
研究概览
简要总结
At present, people still have different opinions on choosing which kind of crystalloid solution for patients with sepsis, and there is no unified standard yet. It is necessary to conduct systematic studies on comparison of different fluid resuscitation methods on the efficacy and safety of crystalloid solution for patients with sepsis. Therefore, this study focuses on the efficacy and safety of sodium bicarbonate Ringer's solution compared with normal saline.
详细描述
Sepsis and septic shock are clinical emergencies requiring immediate treatment and fluid resuscitation. Early effective fluid resuscitation can improve the prognosis of patients. So far, there is no perfect crystalloid solution. Normal saline is the most readily available and economical crystalline fluid for clinical resuscitation. It is isoosmotic and can meet the basic needs of patients in the early rehydration. But it lacks acid-base buffer system and potassium, calcium and magnesium ions, and the level of chloride ions is also significantly higher than that of plasma.
Sodium Bicarbonate Ringer's solution contains physiological levels of Na+(130mmol/L), K+(4mmol/L), Ca2+(1.5mmol/L), Mg2+(1mmol/L), HCO3-(28mmol/L) and Cl-(109mmol/L). It also has citric acid/ sodium citrate buffer system (Citrate3-1.3mmol/L), pH7.3, and osmotic pressure 276mOsm/L. It is the most similar solution to extracellular fluid.
Theoretically，Compared with normal saline, Sodium Bicarbonate Ringer's solution can maintain acid-base balance faster and better when restoring the microcirculation without affecting the level of chloride ion. Therefore we hypothesize that Sodium Bicarbonate Ringer's solution can promote the body to restore to acid-base balance more quickly, and improve organ function more significantly than normal saline.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed as sepsis or septic shock according to the definition of Sepsis-3.0 with fluid resuscitation requirement;
- •aged between 18 and 80, male or female;
- •Signed informed Consent (with delay within 24 hours).
排除标准
- •Patients with hypermagnesemia;
- •Patients with hypothyroidism;
- •Patients predicted to die or discharged within 24 hours after admission;
- •Patients with previous history of mental illness, severe hepatic and renal insufficiency, severe cardiac disease, primary severe central nervous system lesions;
- •Pregnant or breast-feeding women;
- •Patients who have received cardiopulmonary resuscitation；
- •Patients who participated in other clinical trials within 30 days;
- •Patients have other conditions that are not appropriate for inclusion according to the researcher's judgment.
研究组 & 干预措施
Sodium Bicarbonate Ringer's Solution
Intravenous drip, 500~1000ml per time. Infusion speed: 15ml/kg/h or according to guidelines or department routine.
干预措施: Sodium Bicarbonate Ringer's Solution (Drug)
Normal Saline
Intravenous drip, 500~1000ml per time. Dosage depends on age、weight and symptoms.
Infusion speed: According to the department process or clinician's decision.
干预措施: Normal Saline (Drug)
结局指标
主要结局
Change in Sequential Organ Failure Assessment(SOFA) value at 24h
时间窗: 0 hours, 24 hours
ΔSOFA=SOFA24h-SOFA0h
次要结局
- Changes in pH value over time, and the lowest pH value during hospitalization(0 hours, 3 hours, 6 hours, 24 hours)
- The proportion of patients receiving RRT(Within 7 days)
- Serum lactate clearance rate(0 hours, 6 hours)
- The proportion of patients with serum lactate clearance rate>30%(0 hours, 6 hours, 24 hours)
- Changes in base residue (BE value) over time(0 hours, 3 hours, 6 hours, 24 hours)
- Changes in serum bicarbonate(HCO3-) over time(0 hours, 3 hours, 6 hours, 24 hours)
- The proportion of patients with hyperchloremia(0 hours, 3 hours, 24 hours)
- Changes in SOFA score over time(0 hours, 24 hours, 48 hours, 72 hours)
- Changes in APACHEII score over time(0 hours, 24 hours, 48 hours, 72 hours)
- Mechanical ventilation time(h)(Within 7 days)