NCT07542353

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
174

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2023

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 19, 2024

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 26, 2025

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

April 8, 2026

Completed
13 days until next milestone

First Posted

Study publicly available on registry

April 21, 2026

Completed
Last Updated

April 21, 2026

Status Verified

April 1, 2026

Enrollment Period

10 months

First QC Date

April 8, 2026

Last Update Submit

April 14, 2026

Conditions

Lumbar Fusion SurgeryElderly PatientsSodium Acetate Ringer's SolutionSodium Lactate Ringer's SolutionAcute Kidney InjuryBiomarkers

Outcome Measures

Primary Outcomes (1)

  • Urinary neutrophil gelatinase-associated lipocalin (uNGAL)

    Urinary NGAL measured by enzyme-linked immunosorbent assay (ELISA) after standardized sample processing and storage. Higher uNGAL levels indicate greater renal tubular injury.

    Postoperative 6, 12, and 24 hours

Secondary Outcomes (3)

  • 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

Study Arms (2)

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.

Other: Sodium Acetate Ringer's Solution (Group A)

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

Other: Sodium Lactate Ringer's Solution (Group B)

Interventions

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 Acetate Ringer's Solution (Group A)
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.

Sodium Lactate Ringer's Solution (Group B)

Eligibility Criteria

Age65 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • age 65-80 years
  • planned lumbar fusion surgery
  • ability to provide informed consent

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shunde Hospital of Guangzhou University of Chinese Medicine

Foshan, 528300, China

Location

MeSH Terms

Conditions

Acute Kidney Injury

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Shunde Hospital of Guangzhou University of Chinese Medicine

Study Record Dates

First Submitted

April 8, 2026

First Posted

April 21, 2026

Study Start

September 1, 2023

Primary Completion

June 19, 2024

Study Completion

September 26, 2025

Last Updated

April 21, 2026

Record last verified: 2026-04

Locations

CN(1)