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

Completed

• Conditions: Acute Kidney Injury

• Registration Number: NCT03323203
• Lead Sponsor: Xijing Hospital

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2017-10-24
• Study First Submitted QC: 2017-10-24
• Study First Posted: 2017-10-26
• Study Start: 2018-01-04
• Primary Completion: 2019-12-07
• Study Completion: 2019-12-07
• Status Verified: 2020-12
• Last Update Submitted: 2020-12-28
• Last Update Posted: 2020-12-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 110

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Postoperative acute kidney injury (AKI)	Seven days postoperatively	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Xijing Hospital; 🇨🇳 Xi'an, Shaanxi, China