Association of Tissue Oxygen Saturation With Postoperative Acute Kidney Injury in Double Valves Replacement Surgery

Study Overview
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Brief Summary
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To investigate the relationship of tissue oxygenation of different organs and tissue beds (e.g., a tissue bed on the arm vs. leg vs. flank tissue bed(s) and renal tissue bed, and thus can be used as a surrogate of renal tissue oxygenation monitoring.

Detailed Description
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In this study, we will monitor tissue oxygenation of four different tissue beds including cerebral tissue (SctO2) on the forehead, and 3 somatic tissue beds monitored on the forearm (SarmO2), upper leg (SlegO2), and the renal region (SrrO2). The primary end point is AKI and the secondary end points are postoperative major non-renal complications (e.g. stroke, delirium, myocardial infraction, heart failure, new or worsening arrhythmia, mechanical ventilation > 24 hours, deep wound infection, etc.) and mortality. The associations between tissue oxygenation of different tissue beds, i.e. SctO2, SarmO2, SlegO2, and SrrO2, and AKI and non-renal outcomes will be compared to explore the tissue bed(s) whose oxygen saturation has a stronger association with the outcomes of interest. The strength of this study is to use the patient as self-control.

Official Title
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Association of Intraoperative Cerebral and Somatic Tissue Oxygen Saturation With Postoperative Acute Kidney Injury in Adult Patients Undergoing Double Valves Replacement Surgery

Conditions
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Acute Kidney Injury

Intervention / Treatment
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* Device: FORE-SIGHT Elite, CASMED, Inc., Branford, Connecticut, USA


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Written informed consent obtained Age ≥18 years of age Double valves replacement surgery with cardiopulmonary bypass (CPB) Exclusion Criteria: The Trauma, deformity or abnormality sites which the sensor will be put may affect the monitoring of the data Preoperative renal dysfunction needs renal replacement therapy Emergency surgery Preoperative intubated patient Unable to cooperate with the study, i.e., mental illness, et al Patients with hemoglobin and anemia Participate in other trials in the prior 3 months Patient refuses to participate in the study Patient is unfit for the study decided by reach stuff

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: FORE-SIGHT Elite, CASMED, Inc., Branford, Connecticut, USA|Tissue oxygenation was monitored using a tissue oximeter based on near-infrared spectroscopy (FORE-SIGHT Elite, CASMED, Inc., Branford, Connecticut, USA). The oximeter had four cables with each cable connected to an adhesive probe.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative acute kidney injury (AKI) | AKI is defined as any of the following (Not Graded): K Increase in serum creatinine (SCr) by X0.3 mg/dl (X26.5 lmol/l) within 48 hours; or K Increase in SCr to X1.5 times baseline, which is known or presumed to have occurred within the prior 7 days; or K Urine volume o0.5 ml/kg/h for 6 hours.AKI is defined as any of the following (Not Graded): K Increase in SCr by X0.3 mg/dl (X26.5 lmol/l) within 48 hours; or K Increase in SCr to X1.5 times baseline, which is known or presumed to have occurred within the prior 7 days; or K Urine volume o0.5 ml/kg/h for 6 hours. AKI is defined as any of the following (Not graded):Increase in SCr by X0.3 mg/dl (X26.5 lmol/l) within 48 hours; or increase in SCr to X1.5 times baseline, which is known or presumed to have occurred within the prior 7 days; or urine volume less than 0.5 ml/kg/h for 6 hours. | Seven days postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of mechanical ventilation | Time between intubation and extubation | Postoperative day 0-day 7 | 
| Length of ICU stay | Days between end of operation and departure of ICU | Postoperative day 0-day 7 | 
| Length of hospital stay | Days between end of operation and hospital discharge | Postoperative day 0-day 30 | 
| Adverse events in 30 days | Clinical events since hospital discharge | Postoperative day 0-day 30 |