Acute Kidney Injury
Conditions
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 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.
Interventions
PROCEDURENIRS-guided management
NIRS-guided management where a predefined 6-step intervention protocol (volume optimization, vasoactive drugs, inotropes, heart rate management, transfusion, and FiO₂ increase)
PROCEDUREStandard anesthesia management
Standard anesthesia management
Sponsors
Chinese PLA General Hospital
Beijing Tsinghua Changgeng Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
45 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Actue kidney injury | 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| Total duration and proportion of time during surgery of renal desaturation | Intraoperative | Total duration and proportion of time during surgery when renal oxygen saturation decreases by \>10% from baseline |
| Area under the curve for renal oxygen desaturation | Intraoperative | Area under the curve for renal oxygen saturation decrease by \>10% from baseline |
| Use of vasoactive drugs | Intraoperative | The type and total dose of vasoactive drugs |
| Intraoperative blood pressure levels | Intraoperative | Intraoperative low blood pressure and the lowest level |
| AKI grading | Postoperative Day 1-7 | According to serum creatinine level to conduct AKI grade |
| Overall incidence of postoperative complications | Postoperative Day 1-28 | Overall incidence of postoperative complications, including neurological, respiratory, cardiovascular complications, acute kidney injury, and sepsis. |
| mortality | Postoperative Day 1-28 | In-hospital mortality and 28-day postoperative mortality |
Countries
China
Outcome results
None listed