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NCT Number: NCT07542353

Clinical Impact of Different Crystalloid Solution on Early Biomarkers of Kidney Injury After Lumbar Fusion Surgery in Elderly Patients

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.

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Key information

Conditions

Lumbar Fusion Surgery Acute Kidney Injury Biomarkers Elderly Patients Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Renal Insufficiency Sodium Acetate Ringer's Solution Sodium Lactate Ringer's Solution Urogenital Diseases Urologic Diseases

Age range

65 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shunde Hospital of Guangzhou University of Chinese Medicine

Foshan, 528300, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sodium Acetate Ringer's Solution (Group A)

Other

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.

Sodium Lactate Ringer's Solution (Group B)

Other

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.

Primary outcomes

  1. Urinary neutrophil gelatinase-associated lipocalin (uNGAL)

    Time frame: 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 outcomes

  1. Serum creatinine (SCr)

    Time frame: Postoperative 6, 12, and 24 hours

    Serum creatinine measured using an automatic biochemical analyzer. Higher SCr indicates worse renal function.

  2. Estimated glomerular filtration rate (eGFR)

    Time frame: Postoperative 6, 12, and 24 hours

    eGFR calculated using the CKD-EPI equation based on serum creatinine. Lower eGFR indicates worse renal function.

  3. Urinary kidney injury molecule-1 (uKIM-1)

    Time frame: Postoperative 6, 12, and 24 hours

    Urinary KIM-1 measured by enzyme-linked immunosorbent assay (ELISA). Higher uKIM-1 indicates greater renal tubular injury.

Sponsors and collaborators

Lead sponsor

Xianping Wu

Other Gov

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
Apr 21, 2026
Registry last updated
Apr 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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