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NCT07816640
Renal Oxygenation-Guided AKI Reduction Trial
Conditions: Acute Kidney Injury, Hepatectomy
Sex: All
Ages: 45 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 1200
Sponsor: Chinese PLA General Hospital
Location: The First Affiliated Hospital of Anhui Medical University Hefei Anhui
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. 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.
Eligibility Criteria
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 \
Source: ClinicalTrials.gov (NCT07816640). StuddyBuddy aggregates publicly available trial information.