The Comparison Between Ringer Lactate Solution and Normal Saline With Dextrose Water in the First Week Post-Operative Period of Deceased Donor and Living Donor Kidney Transplantation
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 159
- 试验地点
- 1
- 主要终点
- Serum bicarbonate level
研究概览
简要总结
This is a randomized controlled pragmatic clinical trial. We aim to evaluate the effect of Ringer lactate solution (RLS) and normal saline solution (NSS) with dextrose water (D5W) on the electrolyte abnormality of kidney transplant recipients (KTR) during the first post-operative week. The problem with using NSS with or without D5W as a standard replacement fluid is the hyperchloremic metabolic acidosis which might compromise the kidney allograft function. A total 60 KTRs per arm will be enrolled and randomized to receive either RLS or NSS with D5W. The primary outcome is serum bicarbonate level at day 4 after transplantation. Secondary outcomes include the serum potassium, serum sodium, serum chloride, cytokine panel, and the incidence of delayed graft function.
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
- •A kidney transplant recipient who receives transplant at King Chulalongkorn Memorial Hospital.
- •Age >=18 years
- •Both deceased donor and living donor kidney transplantation will be included
排除标准
- •multiorgan transplantation
- •Known allergy to RLS or NSS
研究组 & 干预措施
Ringer lactate arm
The patient will receive RLS as a replacement fluid for urine output (mL per mL) until the patient have sufficient oral intake and fluid can be removed.
干预措施: Ringer's Lactate Crystalloid Solutions (Drug)
Normal saline arm with dextrose water
The patient will receive NSS with D5W as a replacement fluid for urine output (mL per mL) until the patient have sufficient oral intake and fluid can be removed.
干预措施: Normal saline (Drug)
结局指标
主要结局
Serum bicarbonate level
时间窗: Day 5 after transplantation
Serum bicarbonate level
时间窗: Day 4 after transplantation
次要结局
- Serum potassium level(Day 5 after transplantation)
- Serum chloride level(Day 5 after transplantation)
- Immune function marker(Day 5 after transplantation)
- Serum potassium level(Day 4 after transplantation)
- Serum chloride level(Day 4 after transplantation)
- Serum sodium level(Day 4 after transplantation)
- Immune function marker(Day 4 after transplantation)
研究者
Suwasin Udomkarnjananun
Assistant Professor
King Chulalongkorn Memorial Hospital
