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NCT Number: NCT07141693

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

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.

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Key information

Conditions

Acute Kidney Injury Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Renal Insufficiency Urogenital Diseases Urologic Diseases

Age range

45 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Chinese PLA General Hospital

Beijing, Beijing Municipality, 100853, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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)

Standard anesthesia management

Procedure

Standard anesthesia management

Primary outcomes

  1. Actue kidney injury

    Time frame: Postoperative Day 1-7

    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

  2. Comprehensive Complication Index

    Time frame: Postoperative Day 1-28

    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).

Secondary outcomes

  1. Total duration and proportion of time during surgery of renal desaturation

    Time frame: Intraoperative

    Total duration and proportion of time during surgery when renal oxygen saturation decreases by >10% from baseline

  2. Area under the curve for renal oxygen desaturation

    Time frame: Intraoperative

    Area under the curve for renal oxygen saturation decrease by >10% from baseline

  3. Use of vasoactive drugs

    Time frame: Intraoperative

    The type and total dose of vasoactive drugs

  4. Intraoperative blood pressure levels

    Time frame: Intraoperative

    Intraoperative low blood pressure and the lowest level

  5. AKI grading

    Time frame: Postoperative Day 1-7

    According to serum creatinine level to conduct AKI grade

  6. Overall incidence of postoperative complications

    Time frame: Postoperative Day 1-28

    Overall incidence of postoperative complications, including neurological, respiratory, cardiovascular complications, acute kidney injury, and sepsis.

  7. mortality

    Time frame: Postoperative Day 1-28

    In-hospital mortality and 28-day postoperative mortality

Sponsors and collaborators

Lead sponsor

Chinese PLA General Hospital

Other

Collaborators

  • Beijing Tsinghua Changgeng Hospital

Registry information

Official study 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

Acronym: ROGAR

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 26, 2025
Registry last updated
May 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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