跳至主要内容
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2024年9月1日

概览

阶段
3 期
干预措施
Ringer's Lactate Crystalloid Solutions
疾病 / 适应症
Electrolyte Imbalance
发起方
King Chulalongkorn Memorial Hospital
入组人数
159
试验地点
1
主要终点
Serum bicarbonate level
状态
已完成
最后更新
15天前

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 KTR will be enrolled and randomized to receive either RLS or NSS with D5W. The primary outcome is serum bicarbonate level at day 5 after transplantation. Secondary outcomes include the serum potassium, serum sodium, serum chloride, cytokine panel, and the incidence of delayed graft function.

注册库
clinicaltrials.gov
开始日期
2024年9月1日
结束日期
2026年3月24日
最后更新
15天前
研究类型
Interventional
研究设计
Parallel
性别
All

研究者

责任方
Principal Investigator
主要研究者

Suwasin Udomkarnjananun

Assistant Professor

King Chulalongkorn Memorial Hospital

入排标准

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

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

结局指标

主要结局

Serum bicarbonate level

时间窗: Day 5 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)

研究点 (1)

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