Acute Kidney Injury, Biomarkers, Elderly Patients, Lumbar Fusion Surgery, Sodium Acetate Ringer's Solution, Sodium Lactate Ringer's Solution
Conditions
Brief summary
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.
Detailed description
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.
Interventions
OTHERSodium 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.
OTHERSodium 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.
Sponsors
Xianping Wu
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
65 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* age 65-80 years * planned lumbar fusion surgery * ability to provide informed consent
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Urinary neutrophil gelatinase-associated lipocalin (uNGAL) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Serum creatinine (SCr) | Postoperative 6, 12, and 24 hours | Serum creatinine measured using an automatic biochemical analyzer. Higher SCr indicates worse renal function. |
| Estimated glomerular filtration rate (eGFR) | Postoperative 6, 12, and 24 hours | eGFR calculated using the CKD-EPI equation based on serum creatinine. Lower eGFR indicates worse renal function. |
| Urinary kidney injury molecule-1 (uKIM-1) | Postoperative 6, 12, and 24 hours | Urinary KIM-1 measured by enzyme-linked immunosorbent assay (ELISA). Higher uKIM-1 indicates greater renal tubular injury. |
Countries
China
Outcome results
None listed