Renal Oxygenation-Guided AKI Reduction Trial

NCT07816640 | Not Yet Recruiting DMC FDA Device

• 1 other identifier: PLAGH_ROGAR
• Study Type: interventional
• Target: 1,200
• Locations: 1 country
• Sites: 20

Brief Summary

Acute kidney injury (AKI) is a common complication after major liver surgery. This study will evaluate whether intraoperative management guided by renal regional oxygen saturation (RrSO₂), measured using near-infrared spectroscopy, can reduce postoperative acute kidney injury in adults undergoing elective hepatectomy. Approximately 1,200 participants at about 20 hospitals in China will be randomly assigned in a 1:1 ratio to RrSO₂-guided management or usual perioperative care. All participants will undergo continuous bilateral renal RrSO₂ monitoring. In the intervention group, RrSO₂ values will be visible to the anesthesia team, and a decrease of 10% or more from baseline on either side will trigger a standardized assessment and stepwise management algorithm. In the control group, RrSO₂ data will be recorded but concealed from the clinical team and will not guide treatment. The primary outcome is AKI within 7 days after surgery or before hospital discharge, whichever occurs first, based on Kidney Disease: Improving Global Outcomes serum creatinine criteria or initiation of renal replacement therapy.

Conditions

Hepatectomy; Acute Kidney Injury

Keywords

renal regional oxygen saturation; near-infrared spectroscopy; acute kidney injury; hepatectomy; perioperative management; kidney protection

Outcome Measures

Primary Outcomes (1)

• Incidence of postoperative acute kidney injury

  Proportion of participants who develop acute kidney injury (AKI), defined by any of the following: an increase in serum creatinine of ≥0.3 mg/dL (26.5 μmol/L) within 48 hours; an increase in serum creatinine to ≥1.5 times the preoperative baseline within 7 days; or initiation of new renal replacement therapy within 7 days. Urine-output criteria will not be used for the primary outcome.

  From the end of surgery through postoperative day 7 or hospital discharge, whichever occurs first

Secondary Outcomes (10)

• Severity of postoperative AKI

  Through postoperative day 7 or hospital discharge, whichever occurs first

• Postoperative peak serum creatinine

  From the end of surgery until hospital discharge, assessed up to 30 days after surgery.

• Persistence and recovery of AKI

  From the end of surgery through postoperative day 7 or hospital discharge, whichever occurs first, assessed for up to 7 days.

• New Initiation of Renal Replacement Therapy Within 7 Days After Surgery

  Through postoperative Day 7 or hospital discharge, whichever occurs first

• Renal Replacement Therapy Dependence

  Through postoperative day 30

Study Arms (2)

Renal oxygenation-guided perioperative management

EXPERIMENTAL

Bilateral renal regional oxygen saturation will be continuously monitored and displayed to the designated anesthesiologist. A decrease of 10% or more from the corresponding side-specific baseline will trigger assessment of signal validity and a standardized, clinically individualized optimization process addressing volume status, perfusion pressure, cardiac output, heart rate, ventilation and oxygenation, and hemoglobin concentration. Responses after each intervention will be reassessed and recorded.

Device: INVOS 5100C regional oxygen saturation monitoring system; Other: RrSO2-guided perioperative management

Usual perioperative management with blinded renal oxygenation monitoring

ACTIVE COMPARATOR

Bilateral renal regional oxygen saturation will be continuously recorded, but values and trends will be hidden from the anesthesia and surgical teams and will not be used to guide care. Participants will receive usual perioperative management according to current clinical practice and local standards.

Device: INVOS 5100C regional oxygen saturation monitoring system; Other: Usual perioperative management

Interventions

INVOS 5100C regional oxygen saturation monitoring system DEVICE

A near-infrared spectroscopy system will be used to continuously record bilateral renal regional oxygen saturation from before anesthesia induction until the end of the intraoperative monitoring period. The device is used in both study arms; display of the values differs by randomized allocation.

Also known as: Near-infrared spectroscopy; bilateral renal RrSO2 monitoring

Renal oxygenation-guided perioperative management; Usual perioperative management with blinded renal oxygenation monitoring

RrSO2-guided perioperative management OTHER

When either renal RrSO2 decreases by at least 10% from its side-specific baseline, signal artifact and sensor displacement will first be excluded. The anesthesiologist will then assess and treat reversible causes using clinically appropriate measures that may include a small isotonic crystalloid bolus based on goal-directed volume assessment, titrated norepinephrine, dobutamine, treatment of hemodynamically significant bradycardia, optimization of ventilation and oxygenation, and red blood cell transfusion when predefined criteria are met. RrSO2 and hemodynamic responses will be reassessed after each action.

Renal oxygenation-guided perioperative management

Usual perioperative management OTHER

Perioperative anesthesia and hemodynamic management will follow current clinical practice and institutional standards. Renal RrSO2 values will remain hidden and will not be used for clinical decisions.

Usual perioperative management with blinded renal oxygenation monitoring

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chinese PLA General Hospital: lead

Study Sites (20)

The First Affiliated Hospital of Anhui Medical University

Hefei, Anhui, China

Location

Chinese PLA General Hospital

Beijing, Beijing Municipality, 100853, China

Location

Beijing Tsinghua Changgung Hospital

Beijing, Beijing Municipality, China

Location

The First Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, China

Location

The First Hospital of Lanzhou University

Lanzhou, Gansu, China

Location

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

Guangzhou, Guangdong, China

Location

The Third Affiliated Hospital, Sun Yat-sen University

Guangzhou, Guangdong, China

Location

The First Affiliated Hospital of Guangxi Medical University

Nanning, Guangxi, China

Location

The Fourth Hospital of Hebei Medical University

Shijiazhuang, Hebei, China

Location

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, China

Location

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

Location

Hunan Provincial People's Hospital

Changsha, Hunan, China

Location

Xiangya Hospital of Central South University

Changsha, Hunan, China

Location

Qilu Hospital of Shandong University

Qingdao, Shandong, China

Location

The Affiliated Hospital of Qingdao University

Qingdao, Shandong, China

Location

First Hospital of Shanxi Medical University

Taiyuan, Shanxi, China

Location

Zhejiang Provincial People's Hospital

Hangzhou, Zhejiang, China

Location

The First Hospital of Jiaxing

Jiaxing, Zhejiang, China

Location

Taizhou Hospital of Zhejiang Province

Linhai, Zhejiang, China

Location

The First Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, China

Location

MeSH Terms

Conditions

Acute Kidney Injury

Interventions

Spectroscopy, Near-Infrared

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Central Study Contacts

Hao Li

CONTACT

15010665099; lihao301@126.com

Chang Liu

CONTACT

18904089879; liuchang0121eason@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participants and postoperative outcome assessors will be blinded to treatment allocation. The primary statistical analysis team will use coded groups until the prespecified unblinding stage. Intraoperative anesthesiologists and device display personnel cannot be blinded because RrSO2 values must be visible in the intervention arm and hidden in the control arm.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Department of Anesthesiology

Model Details: Two-arm, 1:1, multicenter, parallel-group superiority trial comparing renal oxygenation-guided perioperative management with usual perioperative management.

Study Record Dates

• First Submitted: September 2, 2026
• First Posted: September 14, 2026
• Study Start: September 20, 2026
• Primary Completion (Estimated): November 30, 2027
• Study Completion (Estimated): December 30, 2027
• Last Updated: September 14, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (20)