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NOT YET RECRUITING
NCT07141693
PHASE1

Renal Oximetry-Guided Anesthesia With Near-Infrared Spectroscopy for Improved Postoperative Outcomes

Sponsor: Chinese PLA General Hospital

View on ClinicalTrials.gov

Summary

The trial is a prospective, randomized, single-blind, pilot study investigating whether near-infrared spectroscopy (NIRS)-guided optimization of intraoperative renal oxygen saturation (SrtO₂) 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 SrtO₂ 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.

Official title: Renal Oximetry-Guided Anesthesia With Near-Infrared Spectroscopy for Improved Postoperative Outcomes in Hepatectomy: A Dual-Center, Prospective, Randomized, Single-Blind Investigator-Initiated Pilot Trial

Key Details

Gender

All

Age Range

45 Years - Any

Study Type

INTERVENTIONAL

Enrollment

80

Start Date

2025-09-01

Completion Date

2026-05-30

Last Updated

2025-08-26

Healthy Volunteers

No

Interventions

PROCEDURE

NIRS-guided management

NIRS-guided management where a predefined 6-step intervention protocol (volume optimization, vasoactive drugs, inotropes, heart rate management, transfusion, and FiO₂ increase)

PROCEDURE

Standard anesthesia management

Standard anesthesia management