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| Name | Class |
|---|---|
| Beijing Tsinghua Changgeng Hospital | OTHER |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 FiOâ‚‚ increase) |
|
| Standard anesthesia management | Placebo Comparator | standard anesthesia management |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NIRS-guided management | Procedure | NIRS-guided management where a predefined 6-step intervention protocol (volume optimization, vasoactive drugs, inotropes, heart rate management, transfusion, and FiOâ‚‚ increase) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Total duration and proportion of time during surgery of renal desaturation | Total duration and proportion of time during surgery when renal oxygen saturation decreases by >10% from baseline | Intraoperative |
| Area under the curve for renal oxygen desaturation |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chinese PLA General Hospital | Beijing | Beijing Municipality | 100853 | China |
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| ID | Term |
|---|---|
| D058186 | Acute Kidney Injury |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| Standard anesthesia management | Procedure | Standard anesthesia management |
|
Area under the curve for renal oxygen saturation decrease by >10% from baseline |
| Intraoperative |
| Use of vasoactive drugs | The type and total dose of vasoactive drugs | Intraoperative |
| Intraoperative blood pressure levels | Intraoperative low blood pressure and the lowest level | Intraoperative |
| AKI grading | According to serum creatinine level to conduct AKI grade | Postoperative Day 1-7 |
| Overall incidence of postoperative complications | Overall incidence of postoperative complications, including neurological, respiratory, cardiovascular complications, acute kidney injury, and sepsis. | Postoperative Day 1-28 |
| mortality | In-hospital mortality and 28-day postoperative mortality | Postoperative Day 1-28 |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |