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Renal Oxygenation-Guided AKI Reduction Trial (ROGAR)

9 de septiembre de 2026 actualizado por: 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.

Descripción general del estudio

Estado

Aún no reclutando

Condiciones

Intervención / Tratamiento

Descripción detallada

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.

Tipo de estudio

Intervencionista

Inscripción (Estimado)

1200

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

  • Nombre: Hao Li
  • Número de teléfono: 15010665099
  • Correo electrónico: lihao301@126.com

Copia de seguridad de contactos de estudio

Ubicaciones de estudio

  • Porcelana
    • Anhui
      • Hefei, Anhui, Porcelana
        • The First Affiliated Hospital of Anhui Medical University
        • Contacto:
    • Beijing Municipality
      • Beijing, Beijing Municipality, Porcelana, 100853
        • Chinese PLA General Hospital
        • Contacto:
          • Hao Li
          • Número de teléfono: 15010665099
          • Correo electrónico: lihao301@126.com
        • Contacto:
      • Beijing, Beijing Municipality, Porcelana
        • Beijing Tsinghua Changgung Hospital
        • Contacto:
    • Chongqing Municipality
      • Chongqing, Chongqing Municipality, Porcelana
        • The First Affiliated Hospital of Chongqing Medical University
        • Contacto:
    • Gansu
      • Lanzhou, Gansu, Porcelana
        • The First Hospital of Lanzhou University
        • Contacto:
    • Guangdong
      • Guangzhou, Guangdong, Porcelana
        • Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
        • Contacto:
          • Xiaoyun Lin
          • Número de teléfono: +86 13539498378
      • Guangzhou, Guangdong, Porcelana
        • The Third Affiliated Hospital, Sun Yat-Sen University
        • Contacto:
          • Ziqing Hei
          • Número de teléfono: +86 13925020330
          • Correo electrónico: heiziqing@sina.com
    • Guangxi
      • Nanning, Guangxi, Porcelana
        • The First Affiliated Hospital of Guangxi Medical University
        • Contacto:
          • Yunan Lin
          • Número de teléfono: +86 13768278751
          • Correo electrónico: 2277464077@qq.com
    • Hebei
      • Shijiazhuang, Hebei, Porcelana
        • The Fourth Hospital of Hebei Medical University
        • Contacto:
          • Huaqin Liu
          • Número de teléfono: +86 13582126106
    • Heilongjiang
      • Harbin, Heilongjiang, Porcelana
        • Harbin Medical University Cancer Hospital
        • Contacto:
          • Fei Han
          • Número de teléfono: +86 18686857197
    • Henan
      • Zhengzhou, Henan, Porcelana
        • The First Affiliated Hospital of Zhengzhou University
        • Contacto:
    • Hunan
      • Changsha, Hunan, Porcelana
        • Xiangya Hospital of Central South University
        • Contacto:
      • Changsha, Hunan, Porcelana
        • Hunan Provincial People's Hospital
        • Contacto:
          • Lai Wei
          • Número de teléfono: +86 13975856480
          • Correo electrónico: 448027999@qq.com
    • Shandong
      • Qingdao, Shandong, Porcelana
        • The Affiliated Hospital of Qingdao University
        • Contacto:
          • Aijie Liu
          • Número de teléfono: +86 18661801683
      • Qingdao, Shandong, Porcelana
        • Qilu Hospital of Shandong University
        • Contacto:
          • Dongliang Li
    • Shanxi
      • Taiyuan, Shanxi, Porcelana
        • First Hospital of Shanxi Medical University
        • Contacto:
          • Jieping Lv
          • Número de teléfono: +86 13593131366
    • Zhejiang
      • Hangzhou, Zhejiang, Porcelana
        • Zhejiang Provincial People's Hospital
        • Contacto:
          • Foquan Luo
          • Número de teléfono: +86 13979197017
          • Correo electrónico: lfqjxmc@126.com
      • Jiaxing, Zhejiang, Porcelana
        • The First Hospital of Jiaxing
        • Contacto:
          • Huadong Ni
          • Número de teléfono: +86 15068386387
          • Correo electrónico: huadongni@126.com
      • Linhai, Zhejiang, Porcelana
        • Taizhou Hospital of Zhejiang Province
        • Contacto:
          • Lingyang Chen
          • Número de teléfono: +86 13757600208
          • Correo electrónico: chenly@enzemed.com
      • Wenzhou, Zhejiang, Porcelana
        • The First Affiliated Hospital of Wenzhou Medical University
        • Contacto:
          • Weifeng Yu
          • Número de teléfono: +86 13901961704
          • Correo electrónico: ywf808@yeah.net

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

No

Descripción

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.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Prevención
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Doble

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
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.
Dispositivo: 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.
Otros nombres:
  • Near-infrared spectroscopy; bilateral renal RrSO2 monitoring
Otro: 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.
Comparador activo: 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.
Dispositivo: 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.
Otros nombres:
  • Near-infrared spectroscopy; bilateral renal RrSO2 monitoring
Otro: 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.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Incidence of postoperative acute kidney injury
Periodo de tiempo: 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

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Severity of postoperative AKI
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Chinese PLA General Hospital

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Estimado)

20 de septiembre de 2026

Finalización primaria (Estimado)

30 de noviembre de 2027

Finalización del estudio (Estimado)

30 de diciembre de 2027

Fechas de registro del estudio

Enviado por primera vez

2 de septiembre de 2026

Primero enviado que cumplió con los criterios de control de calidad

9 de septiembre de 2026

Publicado por primera vez (Actual)

14 de septiembre de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

14 de septiembre de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

9 de septiembre de 2026

Última verificación

1 de septiembre de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • PLAGH_ROGAR

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

Sí

producto fabricado y exportado desde los EE. UU.

Sí

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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