Electrolyte Balance Effects of Sterofundin Versus Normal Saline in Diabetic Ketoacidosis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 58
- 试验地点
- 2
- 主要终点
- Mean difference of serum sodium level between Sterofundin and normal saline fluid use in diabetic ketoacidosis patients
研究概览
简要总结
The goal of this prospective single centered randomized control trial is to compare the electrolyte balance effects between Sterofundin and Normal Saline in Diabetic Ketoacidosis patients. The main questions it aims to answer are:
i. Is there any difference in duration of bicarbonate (HCO3-) to reach equal or more than 15mmol/L from the initial blood taking in between Sterofundin and NS fluid use in DKA patients? ii. Is there any difference in the level of post-infusion serum sodium (Na+) between Sterofundin and NS fluid use in DKA patients? iii. Is there any difference in the level of post-infusion serum potassium (K+) between Sterofundin and NS fluid use in DKA patients?
Patients will be randomized in a 1:1 ratio to receive IV Sterofundin (intervention) or IV Normal Saline (standard care). The patient will have the respective fluid regime as the main fluid therapy during the first 24 hours of ICU stay. If patients were randomized to the control arm, the fluid regime for the first 24 hours in ICU will be normal saline. If patients were randomized to the interventional arm, the main fluid therapy during the first 24 hours of ICU stay will be Sterofundin.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged ≥ 18 years old.
- •Patients admitted to ICU < 12 hours after initial fluid resuscitation from emergency department/ ward.
排除标准
- •End stage renal failure
- •Heart failure
- •Started treatment of sodium bicarbonate infusion prior to ICU admission
- •Known allergy to Sterofundin
结局指标
主要结局
Mean difference of serum sodium level between Sterofundin and normal saline fluid use in diabetic ketoacidosis patients
时间窗: 24 Hours
Mean difference of serum potassium level between Sterofundin and normal saline fluid use in diabetic ketoacidosis patients.
时间窗: 24 Hours
The duration taken for serum HCO3 ≥ 15 within 24 hours ICU admission.
时间窗: 24 Hours
次要结局
- The Need of Renal Replacement Therapy(30 days)
- Mechanical ventilation day(30 days)
研究者
Mohd Zulfakar Mazlan, MBBS
Associate Professor
Universiti Sains Malaysia