Clinical trial NCT03323203: Association of Tissue Oxygen Saturation With Postoperative Acute Kidney Injury in Double Valves Replacement Surgery
Official title: Association of Intraoperative Cerebral and Somatic Tissue Oxygen Saturation With Postoperative Acute Kidney Injury in Adult Patients Undergoing Double Valves Replacement Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Kidney Injury
Lead sponsor: Xijing Hospital
Sponsor class: OTHER
First posted: 2017-10-26
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who are going to have double valves replacement surgery

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.

Eligibility criteria: 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

Primary outcomes:
measure: Postoperative acute kidney injury (AKI)
timeFrame: Seven days postoperatively
Secondary outcomes:
measure: Length of mechanical ventilation
timeFrame: Postoperative day 0-day 7
measure: Length of ICU stay
timeFrame: Postoperative day 0-day 7
measure: Length of hospital stay
timeFrame: Postoperative day 0-day 30
measure: Adverse events in 30 days
timeFrame: Postoperative day 0-day 30
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Xijing Hospital
state: Shaanxi
Study officials:
affiliation: Xijing Hospital
name: Hailong Dong, PhD
role: PRINCIPAL_INVESTIGATOR
References: