Lumbar Fusion SurgeryNCT07542353

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

A study testing Sodium Acetate Ringer's Solution (Group A) and Sodium Lactate Ringer's Solution (Group B) in people with Lumbar Fusion Surgery and Elderly Patients, run by Xianping Wu at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 65 to 80 years
Conditions the study is for: Lumbar Fusion Surgery, Elderly Patients, Sodium Acetate Ringer's Solution
What is being tested?: Sodium Acetate Ringer's Solution (Group A) and Sodium Lactate Ringer's Solution (Group B)
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 174 participants
Where: 1 siteChina
Study dates: 1 Sep 2023to 26 Sep 2025
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 65 to 80 years
All sexes
No healthy volunteers
Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

China1 site

Shunde Hospital of Guangzhou University of Chinese Medicine
Foshan, 528300

Other trials in China

About this study

Read the 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.

Conditions: Lumbar Fusion Surgery, Elderly Patients, Sodium Acetate Ringer's Solution, Sodium Lactate Ringer's Solution, Acute Kidney Injury, Biomarkers
Being tested: Sodium Acetate Ringer's Solution (Group A), Sodium Lactate Ringer's Solution (Group B)
Medical subject headings: Acute Kidney Injury

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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.

Study groups in NCT07542353
Study group	Role	What they receive
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. Receives: 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 Receives: Other: Sodium Lactate Ringer's Solution (Group B)

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Postoperative 6, 12, and 24 hours

Secondary outcomes (3)

Serum creatinine (SCr)
Serum creatinine measured using an automatic biochemical analyzer. Higher SCr indicates worse renal function.
Measured: Postoperative 6, 12, and 24 hours
Estimated glomerular filtration rate (eGFR)
eGFR calculated using the CKD-EPI equation based on serum creatinine. Lower eGFR indicates worse renal function.
Measured: Postoperative 6, 12, and 24 hours
Urinary kidney injury molecule-1 (uKIM-1)
Urinary KIM-1 measured by enzyme-linked immunosorbent assay (ELISA). Higher uKIM-1 indicates greater renal tubular injury.
Measured: Postoperative 6, 12, and 24 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Sep 202326 Sep 2025

First posted21 Apr 2026
Study start1 Sep 2023
Primary completion19 Jun 2024
Study completion26 Sep 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Lumbar Fusion SurgeryStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 174 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07542353
Sponsor's protocol ID: KY-2023100
Status last verified: Apr 2026
First submitted: 8 Apr 2026
Last updated: 21 Apr 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 21 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Clinical Impact of Different Crystalloid Solution on Early Biomarkers of Kidney Injury After Lumbar Fusion Surgery in Elderly Patients
ClinicalTrials.gov ID: NCT07542353
Acronym / sponsor ID: KY-2023100
Conditions: Lumbar Fusion Surgery, Elderly Patients, Sodium Acetate Ringer's Solution, Sodium Lactate Ringer's Solution, Acute Kidney Injury, Biomarkers
Study type: Interventional
Recruitment status: Completed
Enrolment: 174 participants (actual)
Lead sponsor: Xianping WuOther government
Study start: 1 Sep 2023 (actual)
Primary completion: 19 Jun 2024 (actual)
Study completion: 26 Sep 2025 (actual)
First posted: 21 Apr 2026 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

The study will evaluate whether the choice of intraoperative crystalloid solution influences early postoperative renal stress in this high-risk population.

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Sodium Acetate Ringer's Solution (Group A)	Other	Other: 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.
Sodium Lactate Ringer's Solution (Group B)	Other	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

Who may qualify

Ages: 65 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Older adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (7 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
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.	Other	Sodium Acetate Ringer's Solution (Group A)
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.	Other	Sodium Lactate Ringer's Solution (Group B)

Primary outcome

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.

3 secondary outcomes

Serum creatinine (SCr)
Time frame: Postoperative 6, 12, and 24 hours
Estimated glomerular filtration rate (eGFR)
Time frame: Postoperative 6, 12, and 24 hours
Urinary kidney injury molecule-1 (uKIM-1)
Time frame: Postoperative 6, 12, and 24 hours

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2026.

Related trials for Lumbar Fusion Surgery

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Recruiting
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Recruiting
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Urinary neutrophil gelatinase-associated lipocalin (uNGAL) (time frame: Postoperative 6, 12, and 24 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07542353.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2026.