A Double-Blind, Randomized Control Trial of Rapidly Infused High Strong Ion Difference Fluid Versus Hartmann's Solution on Acid-Base Status in Sepsis and Septic Shock Patients in the Emergency Department Hospital Pulau Pinang
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 162
- 主要终点
- pH change
研究概览
简要总结
This is a research to study primarily the effect of rapidly infused high strong ion difference (SID) fluid vs Hartmann's solution in altering the pH and bicarbonate level of the patient, who is in sepsis with metabolic acidosis. Half of the study population gets high SID fluid, while the other half will get Hartmann's solution.
详细描述
Balanced fluids are preferred in initial resuscitation of septic patients based on several recent studies.
The Stewart's concept on acid-base balance predicts that high strong ion difference (SID) fluid thus will increase the pH level.
High SID fluid are specially formulated by adding sodium bicarbonate into half saline solution, the resultant fluid contains sodium= 145mmol/L and chloride=70mmol/L (SID= 75) as compared to Hartmann's solution with the SID of 20.
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
- Triple (Participant, Care Provider, Investigator)
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
- •age≥18 years
- •fulfills 2/3 qSOFA criteria
- •presumed infection
- •a blood pH at presentation ≤ 7.35
- •hyperlactatemia (blood lactate level, >2mmol/L )
排除标准
- •existing cardiac failure, major cardiac arrhythmia, advanced chronic kidney disease or end stage failure
- •known pregnancy
- •suspected dengue
- •primary diagnosis is related to burn, trauma, or drug overdose
- •if more than 500cc of resuscitation fluid was administered before enrollment.
研究组 & 干预措施
High SID fluid
Group 1: half-normal saline with addition of 75mEq/L sodium bicarbonate
干预措施: High SID fluid (Combination Product)
Hartmann's solution
Group 2: Hartmann's Solution
干预措施: Hartmann's solution (Combination Product)
结局指标
主要结局
pH change
时间窗: 2 hours
bicarbonate level change
时间窗: 2 hours
mmol/L
次要结局
- Lactate level difference(2 hours)
- Development of pulmonary edema(48 hours)
- Length of stay(90 days)
- 30 days all-cause mortality(30 days)
研究者
Yeoh Chun Chiat
Principal Investigator
Clinical Research Centre, Malaysia