AzTrials
AzTrials

Acute Kidney InjuryROGARNCT07816640

Renal Oxygenation-Guided AKI Reduction Trial

A study testing INVOS 5100C regional oxygen saturation monitoring system, RrSO2-guided perioperative management and Usual perioperative management in people with Acute Kidney Injury and Hepatectomy, run by Chinese PLA General Hospital at 20 sites in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 45 years and older
Conditions the study is for
Acute Kidney Injury, Hepatectomy
What is being tested?
INVOS 5100C regional oxygen saturation monitoring system, RrSO2-guided perioperative management and Usual perioperative management
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,200 participants
Where
20 sitesChina
Study dates
20 Sep 2026to 30 Dec 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

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 45 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

20 sites in 1 country. Contact the study team or a site near you to ask about taking part.

20 sites in 1 country

China20 sites
  • Chinese PLA General Hospital

    Beijing, Beijing Municipality, 100853

    Hao Li, 15010665099, lihao301@126.com

    lihao301@126.com

  • Beijing Tsinghua Changgung Hospital

    Beijing, Beijing Municipality

    Huan Zhang, +86 13611326452, whta01956@btch.edu.cn

  • Hunan Provincial People's Hospital

    Changsha, Hunan

    Lai Wei, +86 13975856480, 448027999@qq.com

  • Xiangya Hospital of Central South University

    Changsha, Hunan

    E Wang, +86 18874889950, ewang324@csu.edu.cn

  • The First Affiliated Hospital of Chongqing Medical University

    Chongqing, Chongqing Municipality

    Su Min, +86 13508302749, ms89011068@163.com

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

    Guangzhou, Guangdong

    Xiaoyun Lin, +86 13539498378

  • The Third Affiliated Hospital, Sun Yat-sen University

    Guangzhou, Guangdong

    Ziqing Hei, +86 13925020330, heiziqing@sina.com

  • Zhejiang Provincial People's Hospital

    Hangzhou, Zhejiang

    Foquan Luo, +86 13979197017, lfqjxmc@126.com

  • Harbin Medical University Cancer Hospital

    Harbin, Heilongjiang

    Fei Han, +86 18686857197

  • The First Affiliated Hospital of Anhui Medical University

    Hefei, Anhui

    Xuesheng Liu, +86 18655193385, liuxuesheng@ahmu.edu.cn

  • The First Hospital of Jiaxing

    Jiaxing, Zhejiang

    Huadong Ni, +86 15068386387, huadongni@126.com

  • The First Hospital of Lanzhou University

    Lanzhou, Gansu

    Yatao Liu, +86 13919451548, doctorliuyt@163.com

  • Taizhou Hospital of Zhejiang Province

    Linhai, Zhejiang

    Lingyang Chen, +86 13757600208, chenly@enzemed.com

  • The First Affiliated Hospital of Guangxi Medical University

    Nanning, Guangxi

    Yunan Lin, +86 13768278751, 2277464077@qq.com

  • Qilu Hospital of Shandong University

    Qingdao, Shandong

    Dongliang Li

  • The Affiliated Hospital of Qingdao University

    Qingdao, Shandong

    Aijie Liu, +86 18661801683

  • The Fourth Hospital of Hebei Medical University

    Shijiazhuang, Hebei

    Huaqin Liu, +86 13582126106

  • First Hospital of Shanxi Medical University

    Taiyuan, Shanxi

    Jieping Lv, +86 13593131366

  • The First Affiliated Hospital of Wenzhou Medical University

    Wenzhou, Zhejiang

    Weifeng Yu, +86 13901961704, ywf808@yeah.net

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan

    Jianjun Yang, +86 13357739238, jianjunyan91971@163.com

Other trials in China

About this study

Official title: 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.

Read the 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.

Being tested
INVOS 5100C regional oxygen saturation monitoring system, RrSO2-guided perioperative management, Usual perioperative management
Keywords
renal regional oxygen saturation; near-infrared spectroscopy; acute kidney injury; hepatectomy; perioperative management; kidney protection
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.

  • INVOS 5100C regional oxygen saturation monitoring systemDevice

    Also called Near-infrared spectroscopy; bilateral renal RrSO2 monitoring

    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.

  • RrSO2-guided perioperative managementOther

    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.

  • Usual perioperative managementOther

    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.

Study groups in NCT07816640
Study groupRoleWhat they receive
Renal oxygenation-guided perioperative managementExperimentalBilateral 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.
Receives: Device: INVOS 5100C regional oxygen saturation monitoring system; Other: RrSO2-guided perioperative management
Usual perioperative management with blinded renal oxygenation monitoringActive comparatorBilateral 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.
Receives: Device: INVOS 5100C regional oxygen saturation monitoring system; Other: Usual perioperative management

What is being measured

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

  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.

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

Secondary outcomes (10)
  1. Severity of postoperative AKI

    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.

    Measured: Through postoperative day 7 or hospital discharge, whichever occurs first

  2. Postoperative peak serum creatinine

    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).

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

  3. Persistence and recovery of AKI

    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.

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

  4. New Initiation of Renal Replacement Therapy Within 7 Days After Surgery

    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.

    Measured: Through postoperative Day 7 or hospital discharge, whichever occurs first

  5. Renal Replacement Therapy Dependence

    The proportion of participants who are receiving renal replacement therapy through postoperative Day 30.

    Measured: Through postoperative day 30

  6. In-hospital clinical recovery outcomes

    In-hospital outcomes will included ICU length of stay, postoperative hospital length of stay.

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

  7. Postoperative morbidity and complication burden

    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).

    Measured: Through postoperative day 30

  8. Health-related quality of life

    Health-related quality of life will be assessed using the validated Chinese version of the EuroQol 5-Dimension 5-Level (EQ-5D-5L).

    Measured: At baseline and postoperative day 30

  9. Healthcare resource use and direct medical costs

    Total direct medical costs incurred from randomization through postoperative Day 30 will be assessed in Chinese yuan (CNY).

    Measured: From randomization through postoperative day 30

  10. All-Cause Mortality Within 30 Days After Surgery

    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.

    Measured: From the end of surgery through postoperative Day 30

Timeline

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

  1. First posted14 Sep 2026
  2. Study start20 Sep 2026 (estimated)
  3. Primary completion30 Nov 2027 (estimated)
  4. Study completion30 Dec 2027 (estimated)

Resources

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
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
Two-arm, 1:1, multicenter, parallel-group superiority trial comparing renal oxygenation-guided perioperative management with usual perioperative management.
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
1,200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07816640
Sponsor's protocol ID
PLAGH_ROGAR
Acronym
ROGAR
Status last verified
Sep 2026
First submitted
2 Sep 2026
Last updated
14 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing INVOS 5100C regional oxygen saturation monitoring system, RrSO2-guided perioperative management and Usual perioperative management in people with Acute Kidney Injury and Hepatectomy, run by Chinese PLA General Hospital at 20 sites in China.

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 7 inclusion and 6 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: opening soon, as of the sponsor's last update on 14 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 20 sites 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?

This study is still under way. Results are not available in the source record yet.

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

Contact Hao Li (15010665099, lihao301@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of postoperative acute kidney injury (time frame: From the end of surgery through postoperative day 7 or hospital discharge, whichever occurs first). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 14 Sep 2026.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in