Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
NOT YET RECRUITING
NCT07816640
NA

Renal Oxygenation-Guided AKI Reduction Trial

Sponsor: Chinese PLA General Hospital

View on ClinicalTrials.gov

Summary

Acute kidney injury (AKI) is a common complication after major liver surgery. This study will evaluate whether intraoperative management guided by renal regional oxygen saturation (RrSO₂), measured using near-infrared spectroscopy, can reduce postoperative acute kidney injury in adults undergoing elective hepatectomy. Approximately 1,200 participants at about 20 hospitals in China will be randomly assigned in a 1:1 ratio to RrSO₂-guided management or usual perioperative care. All participants will undergo continuous bilateral renal RrSO₂ monitoring. In the intervention group, RrSO₂ values will be visible to the anesthesia team, and a decrease of 10% or more from baseline on either side will trigger a standardized assessment and stepwise management algorithm. In the control group, RrSO₂ data will be recorded but concealed from the clinical team and will not guide treatment. The primary outcome is AKI within 7 days after surgery or before hospital discharge, whichever occurs first, based on Kidney Disease: Improving Global Outcomes serum creatinine criteria or initiation of renal replacement therapy.

Official title: Effect of Renal Oxygenation-Guided Perioperative Management on Acute Kidney Injury After Elective Hepatectomy: A Multicenter, Randomized, Controlled, Parallel-Group Superiority Trial

Key Details

Gender

All

Age Range

45 Years - Any

Study Type

INTERVENTIONAL

Enrollment

1200

Start Date

2026-09-20

Completion Date

2027-12-30

Last Updated

2026-09-14

Healthy Volunteers

No

Interventions

DEVICE

INVOS 5100C regional oxygen saturation monitoring system

A near-infrared spectroscopy system will be used to continuously record bilateral renal regional oxygen saturation from before anesthesia induction until the end of the intraoperative monitoring period. The device is used in both study arms; display of the values differs by randomized allocation.

OTHER

RrSO2-guided perioperative management

When either renal RrSO2 decreases by at least 10% from its side-specific baseline, signal artifact and sensor displacement will first be excluded. The anesthesiologist will then assess and treat reversible causes using clinically appropriate measures that may include a small isotonic crystalloid bolus based on goal-directed volume assessment, titrated norepinephrine, dobutamine, treatment of hemodynamically significant bradycardia, optimization of ventilation and oxygenation, and red blood cell transfusion when predefined criteria are met. RrSO2 and hemodynamic responses will be reassessed after each action.

OTHER

Usual perioperative management

Perioperative anesthesia and hemodynamic management will follow current clinical practice and institutional standards. Renal RrSO2 values will remain hidden and will not be used for clinical decisions.

Locations (20)

The First Affiliated Hospital of Anhui Medical University

Hefei, Anhui, China

Chinese PLA General Hospital

Beijing, Beijing Municipality, China

Beijing Tsinghua Changgung Hospital

Beijing, Beijing Municipality, China

The First Affiliated Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, China

The First Hospital of Lanzhou University

Lanzhou, Gansu, China

Sun Yat-sen Memorial Hospital, Sun Yat-sen University

Guangzhou, Guangdong, China

The Third Affiliated Hospital, Sun Yat-sen University

Guangzhou, Guangdong, China

The First Affiliated Hospital of Guangxi Medical University

Nanning, Guangxi, China

The Fourth Hospital of Hebei Medical University

Shijiazhuang, Hebei, China

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, China

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

Hunan Provincial People's Hospital

Changsha, Hunan, China

Xiangya Hospital of Central South University

Changsha, Hunan, China

Qilu Hospital of Shandong University

Qingdao, Shandong, China

The Affiliated Hospital of Qingdao University

Qingdao, Shandong, China

First Hospital of Shanxi Medical University

Taiyuan, Shanxi, China

Zhejiang Provincial People's Hospital

Hangzhou, Zhejiang, China

The First Hospital of Jiaxing

Jiaxing, Zhejiang, China

Taizhou Hospital of Zhejiang Province

Linhai, Zhejiang, China

The First Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, China