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
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Actue kidney injury
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 45 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
Standard anesthesia management
standard anesthesia management
干预措施: Standard anesthesia management (Procedure)
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)
干预措施: NIRS-guided management (Procedure)
结局指标
主要结局
Actue kidney injury
时间窗: 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
Comprehensive Complication Index
时间窗: 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).
次要结局
- 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)
- AKI grading(Postoperative Day 1-7)
- Overall incidence of postoperative complications(Postoperative Day 1-28)
- mortality(Postoperative Day 1-28)
- Intraoperative blood pressure levels(Intraoperative)
研究者
Hao Li
Prof
Chinese PLA General Hospital