Impact of Multiple Electrolytes Injection Ⅱ and Saline on Hyperchloremia in Patients With Aneurysmal Subarachnoid Hemorrhage:a Pilot Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Hyperchloremia
研究概览
简要总结
The goal of this pilot randomized trial is to compare the effect of Multiple Electrolytes Injection Ⅱand saline on the occurrence of hyperchloremia within 72h of randomization in patients with aneurysmal subarachnoid hemorrhage(aSAH). A secondary aim was to provide data for the design and power of a large-scale, multicenter, randomized controlled trial.
详细描述
Background:
The isotonic solutions commonly used in ICUs are saline (0.9% sodium chloride) and balanced crystalloid solutions (Ringer's solution, multiple electrolytes injection, etc.). Studies have shown that the lower chloride in balanced crystalloids compared to saline may result in lower risks of hyperchloremia, acute kidney injury and poor clinical outcome in critical ill patients. As a balanced crystalloid, few evidence was found on multiple electrolytes solution II in patients with aneurysmal subarachnoid hemorrhage (aSAH).
Purpose This study aimed to evaluate the security and feasibility of the study. Moreover, compare the impact of multiple electrolytes injection and saline solution on hyperchloremia in aSAH patients.
Method As a pilot trial of a prospective randomized controlled study, patients with aneurysmal subarachnoid hemorrhage randomly assigned to receive saline or multiple electrolytes injection II as maintenance fluid for 3 days during ICU stay.
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
- Single (Outcomes Assessor)
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 aneurysmal subarachnoid hemorrhage;
- •Expected ICU stay > 24 hours.
排除标准
- •Under 18 years of age;
- •Pregnancy;
- •Patients at imminent risk for death within 24 hours;
- •Patients with a known history of serious cardiovascular, respiratory, kidney, liver, blood, or immune disease;
- •Azotemia (BUN > 200μmol/L), hypokalemia (blood potassium < 2.5mmol/L), hypocalcemia (blood calcium < 1.8mmol/L);
- •Patients routinely receiving renal replacement therapy (RRT);
- •Declined to participate in the study.
研究组 & 干预措施
multiple electrolytes solution group
Experimental group drugs: Multiple Electrolytes Injection(II) Manufacturer: B.Braun Melsungen AG Dosage Form: Liquid Specification: 500ml/ bag Ingredients: Per 1000ml 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 Duration :36 months Storage conditions: airtight storage, storage temperature shall not exceed 25, can not be refrigerated or frozen
干预措施: maintenance fluid (Drug)
saline group
Control group drug: Sodium chloride injection Manufacturer: Hua Run Shuang He Pharmaceutical Co., LTD. Dosage Form: Liquid Specification: 500ml:4.5g Ingredients: Per 1000ml contains sodium chloride 9.0g Duration: 36 months Storage conditions: airtight storage
干预措施: maintenance fluid (Drug)
结局指标
主要结局
Hyperchloremia
时间窗: At 0 hours, 24 hours, 48 hours, 72 hours after enrollment
The incidence of hyperchloremia
次要结局
- Hyperchloremia acidosis(At 0 hours, 24 hours, 48 hours, 72 hours after enrollment)
- hospital length of stay(recorded at discharge or 28 days after enrollment)
- hospitalization expense(recorded at discharge or 28 days after enrollment)
- AKI(recorded at 24 hours, 48 hours, 72 hours after enrollment)
- RRT(recorded at 24 hours, 48 hours, 72 hours after enrollment)
研究者
Jian-Xin Zhou
Professor
Capital Medical University