A Phase 1 interventional study of NIRS-guided management and Standard anesthesia management in Acute Kidney Injury, sponsored by Chinese PLA General Hospital. Completed at 1 site in China. Open to participants aged 45 Years and older. Per ClinicalTrials.gov, last updated 2026-05-08.
Sponsored by Chinese PLA General Hospital · Phase 1, Interventional, and Prevention
The trial is a prospective, randomized, single-blind, pilot study investigating whether near-infrared spectroscopy (NIRS)-guided optimization of intraoperative renal oxygen saturation reduces postoperative acute kidney injury (AKI) in patients undergoing elective hepatectomy. The trial will enroll 80 adults (≥45 years, American society of Aneshesiologists physical status I-III), randomizing them to either standard anesthesia management or NIRS-guided management where a predefined 6-step intervention protocol (volume optimization, vasoactive drugs, inotropes, heart rate management, transfusion, and FiO₂ management) is triggered if decreases >10% from baseline. Primary outcomes are the incidence of AKI within 7 days and the 28-day Comprehensive Complication Index (CCI). The study aims to determine if real-time SrtO₂ monitoring and proactive intervention can prevent this serious complication, based on previous observational data linking renal desaturation to AKI risk.
1,595 studies on the registry are indexed under Acute Kidney Injury; 371 are open to participants now.
This study's enrollment of 80 is below the median of 100 across 763 interventional studies indexed under Acute Kidney Injury.
Browse Acute Kidney Injury studies →Chinese PLA General Hospital is the lead sponsor of 558 studies on the registry; 202 are open to participants now.
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Exclusion Criteria:
NIRS-guided management where a predefined 6-step intervention protocol (volume optimization, vasoactive drugs, inotropes, heart rate management, transfusion, and FiO₂ increase)
Procedure: NIRS-guided management
standard anesthesia management
Procedure: Standard anesthesia management
NIRS-guided management where a predefined 6-step intervention protocol (volume optimization, vasoactive drugs, inotropes, heart rate management, transfusion, and FiO₂ increase)
Standard anesthesia management
Actue kidney injury
An increase in serum creatinine of ≥26.5 μmol/L from baseline within 48 hours or an increase of ≥50% from baseline within 7 days
Time frame: Postoperative Day 1-7
Comprehensive Complication Index
The co-primary outcome is the Comprehensive Complication Index (CCI) score, which includes all complications occurring from randomization to the 28-day follow-up period and calculated using the Clavien-Dindo classification (CDC).
Time frame: Postoperative Day 1-28
Total duration and proportion of time during surgery of renal desaturation
Total duration and proportion of time during surgery when renal oxygen saturation decreases by \>10% from baseline
Time frame: Intraoperative
Area under the curve for renal oxygen desaturation
Area under the curve for renal oxygen saturation decrease by \>10% from baseline
Time frame: Intraoperative
Use of vasoactive drugs
The type and total dose of vasoactive drugs
Time frame: Intraoperative
Intraoperative blood pressure levels
Intraoperative low blood pressure and the lowest level
Time frame: Intraoperative
AKI grading
According to serum creatinine level to conduct AKI grade
Time frame: Postoperative Day 1-7
Overall incidence of postoperative complications
Overall incidence of postoperative complications, including neurological, respiratory, cardiovascular complications, acute kidney injury, and sepsis.
Time frame: Postoperative Day 1-28
mortality
In-hospital mortality and 28-day postoperative mortality
Time frame: Postoperative Day 1-28
Plan to share: No
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This study is completed, as verified in May 2026. You cannot join it, but the record below documents what was studied.
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Chinese PLA General Hospital