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

NCT07141693 | Not Yet Recruiting Phase 1 DMC FDA Device

• 1 other identifier: ChinesePLA_ROGAR_Pilot
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (2)

• 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

  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).

  Postoperative Day 1-28

Secondary Outcomes (7)

• Total duration and proportion of time during surgery of renal desaturation

  Intraoperative

• Area under the curve for renal oxygen desaturation

  Intraoperative

• Use of vasoactive drugs

  Intraoperative

• Intraoperative blood pressure levels

  Intraoperative

• AKI grading

  Postoperative Day 1-7

Study Arms (2)

NIRS-guided anesthesia management group

EXPERIMENTAL

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

PLACEBO COMPARATOR

standard anesthesia management

Procedure: Standard anesthesia management

Interventions

NIRS-guided management PROCEDURE

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

NIRS-guided anesthesia management group

Standard anesthesia management PROCEDURE

Standard anesthesia management

Standard anesthesia management

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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;

Sponsors & Collaborators

• Chinese PLA General Hospital: lead
• Beijing Tsinghua Changgeng Hospital: collaborator

MeSH Terms

Conditions

Acute Kidney Injury

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof

Study Record Dates

• First Submitted: August 9, 2025
• First Posted: August 26, 2025
• Study Start: September 1, 2025
• Primary Completion: April 1, 2026
• Study Completion (Estimated): May 30, 2026
• Last Updated: August 26, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share