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临床试验/NCT06030609
NCT06030609已完成3 期

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

King Chulalongkorn Memorial Hospital1 个研究点 分布在 1 个国家目标入组 159 人开始时间: 2024年9月1日最近更新:
适应症
干预措施
相关药物

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

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

Experimental

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

Active Comparator

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Suwasin Udomkarnjananun

Assistant Professor

King Chulalongkorn Memorial Hospital

研究点 (1)

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