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

NCT ID: NCT07141693

Last Updated: 2025-08-26

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-01
• Study Completion Date: 2026-05-30

Brief 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.

Conditions

Acute Kidney Injury

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

NIRS-guided anesthesia management group

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

Group Type: EXPERIMENTAL

NIRS-guided management

Intervention Type: PROCEDURE

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

standard anesthesia management

Group Type: PLACEBO_COMPARATOR

Standard anesthesia management

Intervention Type: PROCEDURE

Standard anesthesia management

Interventions

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)

Intervention Type: PROCEDURE

Standard anesthesia management

Standard anesthesia management

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Age ≥ 45 years
• Scheduled for elective hepatectomy
• Planned for general anesthesia with endotracheal intubation
• BMI < 30 kg/m2
• Preoperative ultrasound shows renal cortical to skin distance ≤ 4 cm
• ASA classification I-III
• Consenting to participate and signing informed consent

Exclusion Criteria

• Liver transplantation surgery
• Preoperative renal dysfunction or requirement for dialysis treatment;
• Contraindications to vasoactive drugs such as norepinephrine or dopamine as determined by the clinician;
• Severe cardiopulmonary insufficiency (severe arrhythmia, heart failure, respiratory failure, chronic obstructive pulmonary disease), or a serious cardiovascular or cerebrovascular event within the last six months before randomization (such as acute heart failure, acute myocardial infarction, stroke, etc.);
• Patient refusal to participate or current participation in another experimental study;
• Other factors deemed unsuitable for inclusion by the researcher.

• Minimum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beijing Tsinghua Changgeng Hospital

OTHER

Sponsor Role: collaborator

Chinese PLA General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Hao Li

Prof

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

ChinesePLA_ROGAR_Pilot

Identifier Type: -

Identifier Source: org_study_id