Renal Oxygenation-Guided AKI Reduction Trial (ROGAR)

September 9, 2026 updated by: Weidong Mi, Chinese PLA General Hospital

Effect of Renal Oxygenation-Guided Perioperative Management on Acute Kidney Injury After Elective Hepatectomy: A Multicenter, Randomized, Controlled, Parallel-Group Superiority Trial

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

ROGAR is an investigator-initiated, multicenter, prospective, randomized, parallel-group superiority trial enrolling approximately 1,200 adults aged 45 years or older undergoing elective open, laparoscopic, or robot-assisted hepatectomy under general anesthesia. Participants will be randomized 1:1 to renal oxygenation-guided management or usual perioperative care using a centralized allocation system stratified by study center.

All participants will undergo continuous bilateral renal regional oxygen saturation (RrSO₂) monitoring using near-infrared spectroscopy. Before randomization, kidney location and suitability for monitoring will be confirmed by ultrasound, and a baseline RrSO₂ value will be established for each side before anesthesia.

In the intervention group, RrSO₂ values will be visible to the anesthesia team. A decrease of 10% or more from the corresponding side-specific baseline will trigger confirmation of signal validity followed by a standardized stepwise management algorithm addressing clinically relevant determinants of oxygen delivery and perfusion. RrSO₂ and hemodynamic responses will be reassessed after each intervention. In the control group, RrSO₂ will be continuously recorded but concealed from the clinical team and will not guide perioperative management.

Study Type

Interventional

Enrollment (Estimated)

1200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Anhui
      • Hefei, Anhui, China
        • The First Affiliated Hospital of Anhui Medical University
        • Contact:
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100853
      • Beijing, Beijing Municipality, China
        • Beijing Tsinghua Changgung Hospital
        • Contact:
    • Chongqing Municipality
      • Chongqing, Chongqing Municipality, China
        • The First Affiliated Hospital of Chongqing Medical University
        • Contact:
    • Gansu
      • Lanzhou, Gansu, China
        • The First Hospital of Lanzhou University
        • Contact:
    • Guangdong
      • Guangzhou, Guangdong, China
        • Sun Yat-sen Memorial Hospital, Sun Yat-sen University
        • Contact:
          • Xiaoyun Lin
          • Phone Number: +86 13539498378
      • Guangzhou, Guangdong, China
        • The Third Affiliated Hospital, Sun Yat-sen University
        • Contact:
    • Guangxi
      • Nanning, Guangxi, China
        • The First Affiliated Hospital of Guangxi Medical University
        • Contact:
    • Hebei
      • Shijiazhuang, Hebei, China
        • The Fourth Hospital of Hebei Medical University
        • Contact:
          • Huaqin Liu
          • Phone Number: +86 13582126106
    • Heilongjiang
      • Harbin, Heilongjiang, China
        • Harbin Medical University Cancer Hospital
        • Contact:
          • Fei Han
          • Phone Number: +86 18686857197
    • Henan
      • Zhengzhou, Henan, China
        • The First Affiliated Hospital of Zhengzhou University
        • Contact:
    • Hunan
      • Changsha, Hunan, China
        • Xiangya Hospital of Central South University
        • Contact:
      • Changsha, Hunan, China
        • Hunan Provincial People's Hospital
        • Contact:
    • Shandong
      • Qingdao, Shandong, China
        • The Affiliated Hospital Of Qingdao University
        • Contact:
          • Aijie Liu
          • Phone Number: +86 18661801683
      • Qingdao, Shandong, China
        • Qilu Hospital of Shandong University
        • Contact:
          • Dongliang Li
    • Shanxi
      • Taiyuan, Shanxi, China
        • First Hospital of Shanxi Medical University
        • Contact:
          • Jieping Lv
          • Phone Number: +86 13593131366
    • Zhejiang
      • Hangzhou, Zhejiang, China
        • Zhejiang Provincial People's Hospital
        • Contact:
      • Jiaxing, Zhejiang, China
        • The First Hospital of Jiaxing
        • Contact:
      • Linhai, Zhejiang, China
        • Taizhou Hospital of Zhejiang Province
        • Contact:
      • Wenzhou, Zhejiang, China
        • The First Affiliated Hospital of Wenzhou Medical University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Renal oxygenation-guided perioperative management
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
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.
Other Names:
  • Near-infrared spectroscopy; bilateral renal RrSO2 monitoring
Other: RrSO2-guided perioperative management
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.
Active Comparator: Usual perioperative management with blinded renal oxygenation monitoring
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
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.
Other Names:
  • Near-infrared spectroscopy; bilateral renal RrSO2 monitoring
Other: Usual perioperative management
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of postoperative acute kidney injury
Time Frame: From the end of surgery through postoperative day 7 or hospital discharge, whichever occurs first
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Severity of postoperative AKI
Time Frame: Through postoperative day 7 or hospital discharge, whichever occurs first
Highest postoperative acute kidney injury (AKI) stage according to Kidney Disease: Improving Global Outcomes (KDIGO) criteria. Outcomes will include the highest KDIGO stage (no AKI, stage 1, stage 2, or stage 3) and the incidence of severe AKI, defined as KDIGO stage 2 or 3.
Through postoperative day 7 or hospital discharge, whichever occurs first
Postoperative peak serum creatinine
Time Frame: From the end of surgery until hospital discharge, assessed up to 30 days after surgery.
The highest serum creatinine concentration measured after surgery during the index hospitalization will be identified for each participant and reported in micromoles per liter (μmol/L).
From the end of surgery until hospital discharge, assessed up to 30 days after surgery.
Persistence and recovery of AKI
Time Frame: From the end of surgery through postoperative day 7 or hospital discharge, whichever occurs first, assessed for up to 7 days.
Among participants who develop AKI, the clinical course of AKI will be characterized according to prespecified definitions of transient AKI, persistent AKI, and kidney recovery.
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
Time Frame: Through postoperative Day 7 or hospital discharge, whichever occurs first
The proportion of participants who newly initiate renal replacement therapy (RRT) for acute kidney injury from the end of surgery through postoperative Day 7 or hospital discharge, whichever occurs first. Renal replacement therapy includes any form of intermittent or continuous kidney replacement therapy initiated during the assessment period.
Through postoperative Day 7 or hospital discharge, whichever occurs first
Renal Replacement Therapy Dependence
Time Frame: Through postoperative day 30
The proportion of participants who are receiving renal replacement therapy through postoperative Day 30.
Through postoperative day 30
In-hospital clinical recovery outcomes
Time Frame: From the end of surgery to hospital discharge,assessed up to 30 days after surgery.
In-hospital outcomes will included ICU length of stay, postoperative hospital length of stay.
From the end of surgery to hospital discharge,assessed up to 30 days after surgery.
Postoperative morbidity and complication burden
Time Frame: Through postoperative day 30
Postoperative morbidity will be assessed by the Clavien-Dindo grade, and the Comprehensive Complication Index (CCI). The CCI will be calculated from all postoperative complications occurring within 30 days after surgery after assigning a Clavien-Dindo grade to each event and ranges from 0 (no complication) to 100 (death).
Through postoperative day 30
Health-related quality of life
Time Frame: At baseline and postoperative day 30
Health-related quality of life will be assessed using the validated Chinese version of the EuroQol 5-Dimension 5-Level (EQ-5D-5L).
At baseline and postoperative day 30
Healthcare resource use and direct medical costs
Time Frame: From randomization through postoperative day 30
Total direct medical costs incurred from randomization through postoperative Day 30 will be assessed in Chinese yuan (CNY).
From randomization through postoperative day 30
All-Cause Mortality Within 30 Days After Surgery
Time Frame: From the end of surgery through postoperative Day 30
The outcome will be the proportion of participants who die from any cause within 30 days after surgery. The date of death will be recorded when available.
From the end of surgery through postoperative Day 30

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chinese PLA General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 20, 2026

Primary Completion (Estimated)

November 30, 2027

Study Completion (Estimated)

December 30, 2027

Study Registration Dates

First Submitted

September 2, 2026

First Submitted That Met QC Criteria

September 9, 2026

First Posted (Actual)

September 14, 2026

Study Record Updates

Last Update Posted (Actual)

September 14, 2026

Last Update Submitted That Met QC Criteria

September 9, 2026

Last Verified

September 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PLAGH_ROGAR

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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