The Impact of Multiple Electrolytes Injection (II) and Normal Saline on Hyperchloremia in Severe Hemorrhagic Stroke Patients: A Prospective, Multicenter, Open-label, Randomized Controlled Study
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 342
- 试验地点
- 1
- 主要终点
- Hyperchloremia
研究概览
简要总结
Normal saline (0.9% sodium chloride), a classical crystalloid solution, is widely used to maintain fluid balance, volume resuscitation and dilute drugs during clinical practice. However, the chloride concentration of normal saline (154mmol/L) is much higher than human plasma, and a large amount of infusion may lead to iatrogenic hyperchloremia in ICU patients. In contrast, the concentrations of Multiple electrolytes II is more similar to those of plasma and is considered to be a better fluid choice than normal saline.
详细描述
Fluid therapy remains an important part of the treatment and management of critically ill patients. An everyday fluid intake can be simplely divided into: resuscitation fluid, maintenance fluid, nutrition, blood products, drugs and drug carriers. Daily resuscitation and maintenance fluids can account for 31.2% of the total fluid intake and increase during the first 3 days of admission, up to 58.1%, resulting in heavy sodium and chloride loads.
Among them, normal saline (0.9% sodium chloride), a classical crystalloid solution, is widely used to maintain fluid balance, volume resuscitation and dilute drugs. However, the chloride concentration of normal saline (154mmol/L) is much higher than that of human plasma, and a large amount of infusion may lead to iatrogenic hyperchloremia in ICU patients. Hyperchloremia is thought to cause acidosis, decrease in the glomerular filtration rate, impaired renal function, and even mortality. In contrast, the concentrations of balanced crystalloid solutions are more similar to those of plasma and is considered to be a better fluid choice than normal saline.
Hemorrhagic Stroke, which includes spontaneous cerebral hemorrhage and subarachnoid hemorrhage (SAH), is characterized by high mortality and disability. According to the latest studies, there are approximately 1.7 million new hemorrhagic strokes in China each year, and hemorrhagic strokes account for only 30% of all new stroke cases, but 60% of stroke deaths. There is a lack of relevant research on fluid recommendation for this population. One study of subarachnoid hemorrhage suggested that saline caused hyperchloremia, hypertonia, and positive fluid balance over 1500 mL in a large number of patients early after SAH.
Multiple electrolytes II, as a new isotonic balanced salt solution, contains a variety of cations (sodium, potassium, calcium, magnesium) and a lower chloride concentration than normal saline. A study of 30 patients demonstrated that it improved acid-base balance when used in neurosurgery. It may be a new alternative to sodium chloride solution.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with a diagnosis of hemorrhagic stroke (cerebral hemorrhage, intraventricular hemorrhage, or subarachnoid hemorrhage confirmed by CT or MRI, except for subdural or extradural hemorrhage caused by tramma)
- •Patients requiring fluid therapy
- •Patients over 18 years old
排除标准
- •Hemorrhage onset more than 72hours
- •Preexisting hyperchloremia(blood chloride > 110mmol/L)
- •Presence of hypothalamic disease or cerebral salt wasting syndrome
- •Patients who can eat by themselves
- •Patients receiving routine RRT
- •Patients with known allergic or adverse reactions to the liquid used
- •Patients with organ failure (such as heart failure, renal failure, liver failure) or end-stage disease
- •Patients with autoimmune diseases, inflammatory diseases, metabolic diseases and blood diseases
- •Patients with serious heart disease or arrhythmia
- •Patients who are expected to have difficulty complying with the study plan or collecting data completely
- •Pregnant or lactating women
- •No informed consent was signed
- •Patients participating in other clinical trials
- •Other conditions deemed by the investigator to be ineligible for participation in the study
研究组 & 干预措施
Multiple Electrolyte
Multiple Electrolytes Injection(II): contains sodium chloride 6.799g, potassium chloride 0.2984g, calcium chloride 0.3675g, magnesium chloride 0.2033g, sodium acetate 3.266g, L-malic acid 0.671, sodium hydroxide 0.200g per 1000mL.
干预措施: Multiple Electrolyte (Drug)
Normal Saline
Sodium chloride injection: contains sodium chloride 9.0g per 1000mL.
干预措施: Normal Saline (Drug)
结局指标
主要结局
Hyperchloremia
时间窗: At 24 hours, 48 hours, 72 hours after enrollment
The incidence of hyperchloremia
次要结局
- RRT(recorded till day 7 after enrollment)
- ICU length of stay(recorded at ICU discharge or 28 days after enrollment)
- Hyperchloremia acidosis(At 24 hours, 48 hours, 72 hours after enrollment)
- Plasma osmolality(At 24 hours, 48 hours, 72 hours after enrollment)
- AKI(recorded till day 7 after enrollment)
- hospital length of stay(recorded at discharge or 28 days after enrollment)
- hospitalization expense(recorded at discharge or 28 days after enrollment)
研究者
Jian-Xin Zhou
Professor
Capital Medical University