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

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

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.

Study Overview

• Status: Completed
• Conditions: Acute Kidney Injury
• Intervention / Treatment: Device: FORE-SIGHT Elite, CASMED, Inc., Branford, Connecticut, USA

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 Type: Observational
• Enrollment (Actual): 110

Contacts and Locations

Study Locations

• China
  • Shaanxi
    • Xi'an, Shaanxi, China, 710032
      • Xijing Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients who are going to have double valves replacement surgery

Description

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 Plan

How is the study designed?

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Xijing Hospital
• Investigators: Principal Investigator: Hailong Dong, PhD, Xijing Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 4, 2018
• Primary Completion (Actual): December 7, 2019
• Study Completion (Actual): December 7, 2019

Study Registration Dates

• First Submitted: October 24, 2017
• First Submitted That Met QC Criteria: October 24, 2017
• First Posted (Actual): October 26, 2017

Study Record Updates

• Last Update Posted (Actual): December 29, 2020
• Last Update Submitted That Met QC Criteria: December 28, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Renal Insufficiency; Wounds and Injuries; Acute Kidney Injury
• Other Study ID Numbers: KY20172070-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No