Clinical Impact of Different Crystalloid Solution on Early Biomarkers of Kidney Injury After Lumbar Fusion Surgery in Elderly Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 174
- 试验地点
- 1
- 主要终点
- Urinary neutrophil gelatinase-associated lipocalin (uNGAL)
研究概览
简要总结
This study aims to compare the effects of sodium acetate Ringer's solution versus sodium lactate Ringer's solution on early postoperative renal function indicators, renal injury biomarkers, and acute kidney injury (AKI) in elderly patients undergoing lumbar fusion surgery.
详细描述
This is a single-center prospective randomized comparative study. A total of 174 elderly patients scheduled for elective lumbar fusion surgery under general anesthesia will be randomly assigned in a 1:1 ratio to receive either sodium acetate Ringer's solution (Group A, n = 87) or sodium lactate Ringer's solution (Group B, n = 87) for intraoperative fluid management.
Conventional renal function indicators, including serum creatinine (SCr) and estimated glomerular filtration rate (eGFR), as well as early renal injury biomarkers, including lactate, urinary neutrophil gelatinase-associated lipocalin (uNGAL), urinary kidney injury molecule-1 (uKIM-1), and serum cystatin C (sCysC), will be compared between the two groups. Postoperative AKI will be assessed according to the KDIGO serum creatinine criteria.
The study will evaluate whether the choice of intraoperative crystalloid solution influences early postoperative renal stress in this high-risk population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 80 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age 65-80 years
- •planned lumbar fusion surgery
- •ability to provide informed consent
排除标准
- •severe pre-existing cardiac, hepatic, or renal dysfunction
- •known allergy to study fluids
- •use of nephrotoxic drugs within 24 h before surgery
- •emergency surgery
- •severe psychiatric disorders or impaired consciousness
- •intraoperative blood loss >1000 mL or requirement for blood transfusion
- •presence of malignancy
研究组 & 干预措施
Sodium Acetate Ringer's Solution (Group A)
Patients in this arm receive sodium acetate Ringer's solution as the intraoperative crystalloid fluid for management during elective lumbar fusion surgery under general anesthesia. The fluid administration protocol is standardized as follows: (1) initial volume loading of 5-10 mL/kg within 30 minutes after anesthesia induction; (2) maintenance infusion at 5-7 mL/kg/h; and (3) replacement of blood loss at a crystalloid-to-blood loss ratio of approximately 3:1. Infusion rates are adjusted based on stroke volume variation and hemodynamic parameters. The assigned crystalloid solution is also used as the carrier fluid for any required vasoactive medications. This arm is compared against a control arm receiving sodium lactate Ringer's solution. The target population consists of elderly patients (aged 65-80 years) scheduled for lumbar fusion surgery.
干预措施: Sodium Acetate Ringer's Solution (Group A) (Other)
Sodium Lactate Ringer's Solution (Group B)
Patients in this arm receive sodium lactate Ringer's solution as the intraoperative crystalloid fluid for management during elective lumbar fusion surgery under general anesthesia. The fluid administration protocol is identical to that of the experimental arm: (1) initial volume loading of 5-10 mL/kg within 30 minutes after anesthesia induction; (2) maintenance infusion at 5-7 mL/kg/h; and (3) replacement of blood loss at a crystalloid-to-blood loss ratio of approximately 3:1. Infusion rates are adjusted based on stroke volume variation and hemodynamic parameters. The assigned crystalloid solution is also used as the carrier fluid for any required vasoactive medications. This arm serves as the active comparator against sodium acetate Ringer's solution. The target population consists of elderly patients (aged 65-80 years) scheduled for lumbar fusion surgery
干预措施: Sodium Lactate Ringer's Solution (Group B) (Other)
结局指标
主要结局
Urinary neutrophil gelatinase-associated lipocalin (uNGAL)
时间窗: Postoperative 6, 12, and 24 hours
Urinary NGAL measured by enzyme-linked immunosorbent assay (ELISA) after standardized sample processing and storage. Higher uNGAL levels indicate greater renal tubular injury.
次要结局
- Serum creatinine (SCr)(Postoperative 6, 12, and 24 hours)
- Estimated glomerular filtration rate (eGFR)(Postoperative 6, 12, and 24 hours)
- Urinary kidney injury molecule-1 (uKIM-1)(Postoperative 6, 12, and 24 hours)
研究者
Xianping Wu
Shunde Hospital of Guangzhou University of Chinese Medicine
Shunde Hospital of Guangzhou University of Chinese Medicine