Not yet recruitingNCT07816640ClinicalTrials.gov record

Renal Oxygenation-Guided AKI Reduction Trial

Acute Kidney Injury · Hepatectomy

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THE QUICK READ

What this study involves

The registry does not currently label this study as recruiting. Ask about its status before planning a screening visit.

Study type: Interventional
Phase: Not applicable
Age range: 45 years - Not specified
Sex eligible: All sexes
Healthy volunteers: Not accepted
Participants: 1200 Estimated

These are starting points, not an eligibility decision. The research team must review the full requirements.

About the research

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 full 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.

Who may be able to participate?

The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.

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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Treatment, groups and participation

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Assignment: Random assignment
Masking: Double masked

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 · Other: RrSO2-guided perioperative management

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 · Other: Usual perioperative management

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.

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.

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.

Prepare your questions

What researchers are measuring

Outcome measures describe what is being studied. They are not proof that a treatment works.

Primary measures

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.

Secondary measures

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.

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).

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.

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.

Renal Replacement Therapy Dependence

Time frame: Through postoperative day 30

The proportion of participants who are receiving renal replacement therapy 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.

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).

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).

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).

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.

No results are flagged as posted.

Review the complete result tables and limitations in the official record.

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Research locations (20)

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20 locations

The First Affiliated Hospital of Anhui Medical UniversityHefei, Anhui, ChinaStatus unknown

Xuesheng LiuCONTACTliuxuesheng@ahmu.edu.cn +86 18655193385