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Can watching kidney oxygen during liver surgery keep kidneys safe?

NCT ID NCT07816640

Prevention Sponsor: Chinese PLA General Hospital Source: ClinicalTrials.gov ↗

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
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Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

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Status unknown
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First seen Sep 14, 2026 · Last updated Sep 15, 2026 · Updated 1 time

Summary

Acute kidney injury is a common complication after major liver surgery. This trial tests whether adjusting anesthesia care based on real-time kidney oxygen readings, measured with near-infrared spectroscopy, can reduce kidney injury after elective hepatectomy. About 1,200 adults scheduled for liver removal at roughly 20 hospitals in China join, with half receiving oxygen-guided care and half receiving usual care. Researchers compare rates of acute kidney injury within seven days after surgery.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
near-infrared spectroscopy monitoring of kidney oxygen levels to guide anesthesia care
What this could lead to
If it works, this could give surgical teams a real-time way to protect kidneys during liver surgery and lower the chance of postoperative kidney injury.
What could go wrong
The approach may not translate into fewer kidney injuries, and monitoring adds equipment and protocol demands that some hospitals may find hard to adopt. Results will take time to confirm across many centers.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 1,200 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

45 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Age ≥45 years. * Scheduled for elective open, laparoscopic, or robot-assisted hepatectomy. * Planned general anesthesia with tracheal intubation and an expected surgical duration ≥2 hours. * Stable preoperative serum creatinine available before randomization, with baseline estimated glomerular filtration rate (eGFR) ≥60 mL/min/1.73 m². * Body mass index \<30 kg/m² and bilateral renal cortex-to-skin distance ≤4 cm on ultrasound, allowing reliable bilateral renal NIRS monitoring and stable baseline RrSO₂ signals. * American Society of Anesthesiologists physical status I-III. * Ability to understand the study and provide written informed consent. Exclusion Criteria: * Pre-existing or unstable renal dysfunction, including eGFR \<60 mL/min/1.73 m², AKI before randomization, unstable or progressively increasing serum creatinine, end-stage kidney disease, chronic dialysis, previous kidney transplantation, or other significant renal disease that may interfere with postoperative AKI assessment. * Concomitant surgery expected to directly affect renal function assessment, including nephrectomy, kidney transplantation, or renal artery or vein reconstruction. * Emergency or rescue surgery, or inability to provide valid informed consent before surgery. * Inability to obtain reliable bilateral renal RrSO₂ monitoring because of excessive tissue depth, positioning, skin lesions, scars, infection, hematoma, severe edema, jaundice, or other technical or anatomical factors despite appropriate sensor repositioning and troubleshooting. * Severe systemic disease or high perioperative risk, including severe cardiac or pulmonary dysfunction, recent major cardiovascular or cerebrovascular events, severe anemia, or any condition judged by the investigator to make participation unsafe. * Participation in another interventional clinical trial that may affect perioperative management, AKI risk, or the primary outcome, or any other condition judged by the investigator to make participation unsuitable.

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Conditions

The condition(s) this trial relates to.

acute kidney injury

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Acute kidney injury Hepatectomy

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    20 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Beijing Tsinghua Changgung Hospital

    Beijing, Beijing Municipality, China

  • Chinese PLA General Hospital

    Beijing, Beijing Municipality, 100853, China

  • First Hospital of Shanxi Medical University

    Taiyuan, Shanxi, China

  • Harbin Medical University Cancer Hospital

    Harbin, Heilongjiang, China

  • Hunan Provincial People's Hospital

    Changsha, Hunan, China

  • Qilu Hospital of Shandong University

    Qingdao, Shandong, China

  • Sun Yat-sen Memorial Hospital, Sun Yat-sen University

    Guangzhou, Guangdong, China

  • Taizhou Hospital of Zhejiang Province

    Linhai, Zhejiang, China

  • The Affiliated Hospital of Qingdao University

    Qingdao, Shandong, China

  • The First Affiliated Hospital of Anhui Medical University

    Hefei, Anhui, China

  • The First Affiliated Hospital of Chongqing Medical University

    Chongqing, Chongqing Municipality, China

  • The First Affiliated Hospital of Guangxi Medical University

    Nanning, Guangxi, China

  • The First Affiliated Hospital of Wenzhou Medical University

    Wenzhou, Zhejiang, China

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan, China

  • The First Hospital of Jiaxing

    Jiaxing, Zhejiang, China

  • The First Hospital of Lanzhou University

    Lanzhou, Gansu, China

  • The Fourth Hospital of Hebei Medical University

    Shijiazhuang, Hebei, China

  • The Third Affiliated Hospital, Sun Yat-sen University

    Guangzhou, Guangdong, China

  • Xiangya Hospital of Central South University

    Changsha, Hunan, China

  • Zhejiang Provincial People's Hospital

    Hangzhou, Zhejiang, China

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