Renal Oxygenation-Guided AKI Reduction Trial
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age45+
SponsorChinese PLA General Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥45 years.
Scheduled for elective open, laparoscopic, or robot-assisted hepatectomy.
Planned general anesthesia with tracheal intubation and an expected surgical duration ≥2 hours.
Stable preoperative serum creatinine available before randomization, with baseline estimated glomerular filtration rate (eGFR) ≥60 mL/min/1.73 m².
Disqualifiers
Pre-existing or unstable renal dysfunction, including eGFR <60 mL/min/1.73 m², AKI before randomization, unstable or progressively increasing serum creatinine, end-stage kidney disease, chronic dialysis, previous kidney transplantation, or other significant renal disease that may interfere with postoperative AKI assessment.
Concomitant surgery expected to directly affect renal function assessment, including nephrectomy, kidney transplantation, or renal artery or vein reconstruction.
Emergency or rescue surgery, or inability to provide valid informed consent before surgery.
Inability to obtain reliable bilateral renal RrSO₂ monitoring because of excessive tissue depth, positioning, skin lesions, scars, infection, hematoma, severe edema, jaundice, or other technical or anatomical factors despite appropriate sensor repositioning and troubleshooting.
Trial design
Design model
Parallel
Treatments tested in this trial
INVOS 5100C regional oxygen saturation monitoring system
DeviceA 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.
RrSO2-guided perioperative management
Other interventionWhen 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.
Usual perioperative management
Other interventionPerioperative 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.
Treatment groups
1,200 Participants
are divided into 2 treatment groupsGroup A: Renal oxygenation-guided perioperative managementExperimental treatment 2 interventions
Group B: Usual perioperative management with blinded renal oxygenation monitoringActive comparator 2 interventions
Trial outcomes
Primary outcomes
1
Incidence of postoperative acute kidney injury
Proportion of participants who develop acute kidney injury (AKI), defined by any of the following: an increase in serum creatinine of ≥0.3 mg/dL (26.5 μmol/L) within 48 hours; an increase in serum creatinine to ≥1.5 times the preoperative baseline within 7 days; or initiation of new renal replacement therapy within 7 days. Urine-output criteria will not be used for the primary outcome.
Time frame
From the end of surgery through postoperative day 7 or hospital discharge, whichever occurs firstSecondary outcomes
1
Severity of postoperative AKI
Highest postoperative acute kidney injury (AKI) stage according to Kidney Disease: Improving Global Outcomes (KDIGO) criteria. Outcomes will include the highest KDIGO stage (no AKI, stage 1, stage 2, or stage 3) and the incidence of severe AKI, defined as KDIGO stage 2 or 3.
Time frame
Through postoperative day 7 or hospital discharge, whichever occurs first2
Postoperative peak serum creatinine
The highest serum creatinine concentration measured after surgery during the index hospitalization will be identified for each participant and reported in micromoles per liter (μmol/L).
Time frame
From the end of surgery until hospital discharge, assessed up to 30 days after surgery.3
Persistence and recovery of AKI
Among participants who develop AKI, the clinical course of AKI will be characterized according to prespecified definitions of transient AKI, persistent AKI, and kidney recovery.
Time frame
From the end of surgery through postoperative day 7 or hospital discharge, whichever occurs first, assessed for up to 7 days.4
New Initiation of Renal Replacement Therapy Within 7 Days After Surgery
The proportion of participants who newly initiate renal replacement therapy (RRT) for acute kidney injury from the end of surgery through postoperative Day 7 or hospital discharge, whichever occurs first. Renal replacement therapy includes any form of intermittent or continuous kidney replacement therapy initiated during the assessment period.
Time frame
Through postoperative Day 7 or hospital discharge, whichever occurs firstSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: