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Renal Oxygenation-Guided AKI Reduction Trial (ROGAR)

9. September 2026 aktualisiert von: 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.

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Geschätzt)

1200

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studieren Sie die Kontaktsicherung

Studienorte

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

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Verhütung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Doppelt

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
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.
Gerät: 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.
Andere Namen:
  • Near-infrared spectroscopy; bilateral renal RrSO2 monitoring
Sonstiges: 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.
Aktiver Komparator: 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.
Gerät: 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.
Andere Namen:
  • Near-infrared spectroscopy; bilateral renal RrSO2 monitoring
Sonstiges: 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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Incidence of postoperative acute kidney injury
Zeitfenster: 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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Severity of postoperative AKI
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Chinese PLA General Hospital

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

20. September 2026

Primärer Abschluss (Geschätzt)

30. November 2027

Studienabschluss (Geschätzt)

30. Dezember 2027

Studienanmeldedaten

Zuerst eingereicht

2. September 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

9. September 2026

Zuerst gepostet (Tatsächlich)

14. September 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

14. September 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

9. September 2026

Zuletzt verifiziert

1. September 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • PLAGH_ROGAR

Plan für individuelle Teilnehmerdaten (IPD)

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NEIN

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Ja

Produkt, das in den USA hergestellt und aus den USA exportiert wird

Ja

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