NCT03323203

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 110 (actual)
• Sponsor: Xijing Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Acute Kidney Injury

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2018-01-04
• Primary completion: 2019-12-07
• Completion: 2019-12-07
• First posted: 2017-10-26
• Last updated: 2020-12-29

Locations

1 site across 1 country: China