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Renal Oxygenation-Guided AKI Reduction Trial (ROGAR)

2026年9月9日 更新者：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.

調査の概要

状態

まだ募集していません

条件

介入・治療

詳細な説明

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.

研究の種類

介入

入学 (推定)

1200

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

研究連絡先のバックアップ

研究場所

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

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 大人
  • 高齢者

健康ボランティアの受け入れ

いいえ

説明

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.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：防止
  • 割り当て：ランダム化
  • 介入モデル：並列代入
  • マスキング：ダブル

武器と介入

参加者グループ / アーム
介入・治療
実験的：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.
デバイス：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.
他の名前：
  • Near-infrared spectroscopy; bilateral renal RrSO2 monitoring
他の：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.
アクティブコンパレータ：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.
デバイス：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.
他の名前：
  • Near-infrared spectroscopy; bilateral renal RrSO2 monitoring
他の：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.

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Incidence of postoperative acute kidney injury
時間枠：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

二次結果の測定

結果測定
メジャーの説明
時間枠
Severity of postoperative AKI
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Chinese PLA General Hospital

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (推定)

2026年9月20日

一次修了 (推定)

2027年11月30日

研究の完了 (推定)

2027年12月30日

試験登録日

最初に提出

2026年9月2日

QC基準を満たした最初の提出物

2026年9月9日

最初の投稿 (実際)

2026年9月14日

学習記録の更新

投稿された最後の更新 (実際)

2026年9月14日

QC基準を満たした最後の更新が送信されました

2026年9月9日

最終確認日

2026年9月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • PLAGH_ROGAR

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

いいえ

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米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

はい

米国で製造され、米国から輸出された製品。

はい

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